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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05572515
Registration number
NCT05572515
Ethics application status
Date submitted
5/10/2022
Date registered
7/10/2022
Titles & IDs
Public title
A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma
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Scientific title
A Phase 3 Randomized Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Monoclonal Antibody and Lenalidomide
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Secondary ID [1]
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64007957MMY3006
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Secondary ID [2]
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CR109244
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Universal Trial Number (UTN)
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Trial acronym
MajesTEC-9
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Relapsed or Refractory Multiple Myeloma
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Condition category
Condition code
Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Teclistamab
Treatment: Drugs - Pomalidomide
Treatment: Drugs - Bortezomib
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Carfilzomib
Experimental: Teclistamab - Participants will receive teclistamab monotherapy.
Experimental: Pomalidomide, Bortezomib and Dexamethasone (PVd) or Carfilzomib and Dexamethasone (Kd) - Participants will receive either PVd or Kd based on principal investigator's choice.
Treatment: Drugs: Teclistamab
Teclistamab will be administered subcutaneously.
Treatment: Drugs: Pomalidomide
Pomalidomide will be administered orally.
Treatment: Drugs: Bortezomib
Bortezomib will be administered subcutaneously.
Treatment: Drugs: Dexamethasone
Dexamethasone will be administered orally in PVd and intravenously or orally in Kd.
Treatment: Drugs: Carfilzomib
Carfilzomib will be administered intravenously.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival (PFS)
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Assessment method [1]
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PFS is defined as the time from the date of randomization to the date of first documented disease progression, as defined in the International myeloma working group (IMWG) 2016 response criteria, or death due to any cause, whichever occurs first.
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Timepoint [1]
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Up to 9 years
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Secondary outcome [1]
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Overall Response (Partial Response [PR] or Better)
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Assessment method [1]
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Overall response (PR or better) is defined as participants who have a PR or better prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 criteria.
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Timepoint [1]
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Up to 9 years
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Secondary outcome [2]
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Very Good Partial Response (VGPR) or Better Response
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Assessment method [2]
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VGPR or better (Stringent Complete Response \[sCR\]+Complete Response \[CR\]+VGPR) is defined as participants who achieve a VGPR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 criteria.
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Timepoint [2]
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Up to 9 years
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Secondary outcome [3]
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Complete Response (CR) or Better Response
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Assessment method [3]
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CR or better response is defined as participants who achieve a CR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 criteria.
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Timepoint [3]
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Up to 9 years
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Secondary outcome [4]
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Duration of Response (DOR)
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Assessment method [4]
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DOR is defined as the time interval between the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG 2016 response criteria or death due to any cause, whichever occurs first.
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Timepoint [4]
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Up to 9 years
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Secondary outcome [5]
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Time to Next Treatment (TTNT)
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Assessment method [5]
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TTNT is defined as the time from randomization to the start of subsequent antimyeloma treatment.
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Timepoint [5]
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Up to 9 years
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Secondary outcome [6]
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Progression-free Survival on Next-line Therapy (PFS2)
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Assessment method [6]
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PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as progressive disease as assessed by investigator on the first subsequent line of antimyeloma therapy, or death from any cause, whichever occurs first.
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Timepoint [6]
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0
Up to 9 years
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Secondary outcome [7]
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Overall Survival (OS)
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Assessment method [7]
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OS is defined as the time from the date of randomization to the date of the participant's death due to any cause.
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Timepoint [7]
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Up to 9 years
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Secondary outcome [8]
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Number of Participants with Adverse Events (AEs) by Severity
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Assessment method [8]
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Number of participants with AEs by Severity will be reported.
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Timepoint [8]
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0
Up to 9 years
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Secondary outcome [9]
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Number of Participants with Serious Adverse Events (SAEs) by Severity
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Assessment method [9]
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Number of participants with SAEs by Severity will be reported.
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Timepoint [9]
0
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Up to 9 years
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Secondary outcome [10]
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Number of Participants with Abnormal Laboratory Results
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Assessment method [10]
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Number of participants with abnormal laboratory results (such as hematology and chemistry) will be reported.
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Timepoint [10]
0
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Up to 9 years
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Secondary outcome [11]
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Serum Concentrations of Teclistamab
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Assessment method [11]
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Serum concentrations of teclistamab will be reported.
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Timepoint [11]
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Up to 9 years
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Secondary outcome [12]
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Number of Participants with Anti-drug Antibodies (ADAs) to Teclistamab
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Assessment method [12]
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Number of participants with ADAs to teclistamab will be reported.
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Timepoint [12]
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Up to 9 years
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Secondary outcome [13]
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Change from Baseline in Symptoms, Functioning, and Overall Health-related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30)
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Assessment method [13]
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Change from baseline in symptoms, functioning, and overall HRQoL assessed by EORTC QLQ-C30 score version 3 will be reported. The EORTC- QLQ-C30 Version 3 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
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Timepoint [13]
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Baseline up to 9 years
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Secondary outcome [14]
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Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Score
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Assessment method [14]
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Change from baseline in symptoms, functioning, and overall HRQoL assessed by MySIm-Q will be reported. The MySIm-Q is a disease-specific PRO assessment complementary to the EORTC-QLQ-C30. It includes 17 items resulting in a symptom subscale and an impact subscale. The recall period is the "past 7 days", and responses are reported on a 5-point verbal rating scale.
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Timepoint [14]
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Baseline up to 9 years
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Secondary outcome [15]
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Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
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Assessment method [15]
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Change from baseline in symptoms, functioning, and overall HRQoL assessed by PRO-CTCAE will be reported. The National Cancer Institute's (NCI's) PRO-CTCAE is an item library of common adverse events experienced by people with cancer that are appropriate for self-reporting of treatment tolerability. Each symptom selected for inclusion can be rated by up to 3 attributes characterizing the presence/frequency, severity, and/or interference of the AEs. It ranges from 0 to 4 with higher scores indicating higher frequency or greater severity/impact.
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Timepoint [15]
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Baseline up to 6 months
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Secondary outcome [16]
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Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
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Assessment method [16]
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Change from baseline in symptoms, functioning, and overall HRQoL assessed by EQ-5D-5L will be reported. The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
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Timepoint [16]
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Baseline up to 9 years
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Secondary outcome [17]
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Time to Worsening in Symptoms, Functioning, and Overall HRQoL
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Assessment method [17]
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Time to worsening in symptoms, functioning, and overall HRQoL will be measured as the interval from the date of randomization to the start date of meaningful change.
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Timepoint [17]
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Up to 9 years
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Secondary outcome [18]
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PFS in Participants in High-risk Molecular Features
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Assessment method [18]
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PFS in participants in high-risk molecular features will be reported. PFS is defined as the time from the date of randomization to the date of first documented disease progression, as defined in the IMWG 2016 response criteria, or death due to any cause, whichever occurs first.
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Timepoint [18]
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Up to 9 years
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Secondary outcome [19]
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Depth of Response in Participants in High-risk Molecular Features
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Assessment method [19]
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Depth of response in participants in high-risk molecular features will be reported.
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Timepoint [19]
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Up to 9 years
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Eligibility
Key inclusion criteria
* Documented diagnosis of multiple myeloma as defined by the criteria below: (a)Multiple myeloma diagnosis according to International Myeloma Working Group (IMWG) diagnostic criteria (b) Measurable disease at screening as defined by any of the following: (1) Serum M-protein level greater than or equal to (>=)0.5 grams per deciliter (g/dL) (central laboratory); or (2) Urine M-protein level >=200 milligrams (mg)/24 hours (central laboratory); or (3) Serum immunoglobulin free light chain >=10 milligrams per deciliter (mg/dL) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio
* Received 1 to 3 prior lines of antimyeloma therapy including a minimum of 2 consecutive cycles of an anti- cluster of differentiation 38 (CD38) monoclonal antibody at the approved dosing regimen in any prior line and 2 consecutive cycles of lenalidomide in any prior line
* Documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator's determination of response by International myeloma working group (IMWG) criteria
* Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
* A female participant must agree not to be pregnant, breast-feeding, or plan to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
* Must be willing and able to adhere to the lifestyle restrictions specified in this protocol
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Received any prior B cell maturation antigen (BCMA)-directed therapy
* A participant is not eligible to receive PVd as control therapy if any of the following are present: (1) Received prior pomalidomide therapy, (2) Does not meet criteria for bortezomib retreatment (3) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide or bortezomib, (4) Grade 1 peripheral neuropathy with pain or Grade greater than or equal to (>=) 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, (5) Received a strong cytochrome P (CYP) 3A4 inducer within 5 half-lives prior to randomization; A participant is not eligible to receive Kd as control therapy if any of the following are present:(1) Received prior carfilzomib therapy, (2) Uncontrolled hypertension, defined as an average systolic blood pressure greater than (>)159 millimeters of mercury (mmHg) or diastolic blood pressure >99 mmHg despite optimal treatment (3) Grade 2 peripheral neuropathy with pain or Grade >=3 peripheral neuropathy as defined by NCI-CTCAE Version 5.0, (4) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to carfilzomib (intolerance defined as prior therapy discontinued due to any adverse event [AE] related to carfilzomib)
* Central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma.
* Received a live, attenuated vaccine within 4 weeks before randomization
* Plasma cell leukemia at the time of screening, Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein (POEMS) syndrome and skin changes, or primary amyloid light chain amyloidosis
* Received a maximum cumulative dose of corticosteroids of >=140 mg of prednisone or equivalent within 14 days prior to randomization
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/03/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/08/2031
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Actual
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Sample size
Target
590
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Blacktown Hospital - Blacktown
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Recruitment hospital [2]
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St Vincents Hospital Melbourne - Fitzroy
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Recruitment hospital [3]
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Box Hill Hospital - Melbourne
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Recruitment hospital [4]
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Fiona Stanley Hospital - Murdoch
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Recruitment hospital [5]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
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2148 - Blacktown
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Recruitment postcode(s) [2]
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3065 - Fitzroy
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Recruitment postcode(s) [3]
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3128 - Melbourne
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Recruitment postcode(s) [4]
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6150 - Murdoch
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Recruitment postcode(s) [5]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alaska
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United States of America
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California
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Iowa
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United States of America
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Louisiana
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Maryland
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Massachusetts
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Missouri
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New Jersey
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New York
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North Carolina
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Pennsylvania
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Texas
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Utah
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Virginia
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Austria
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Salzburg
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Austria
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Vienna
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Brasschaat
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Haine-St-Paul
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Kortrijk
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Leuven
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Liege
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Brazil
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Brasilia
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Brazil
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Caxias do Sul
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Brazil
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Curitiba
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Brazil
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Joinville
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Brazil
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Natal
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Niteroi
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Rio de Janeiro
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São Paulo
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Alberta
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Canada
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Ontario
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China
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Beijing
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Changchun
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China
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Changsha
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Chengdu
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Chongqing
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China
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Fu Zhou
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China
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Guangzhou
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China
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Hangzhou
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Harbin
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China
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Nanchang
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Nanjing
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China
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Nanning
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Shanghai
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Shenyang
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China
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Shenzhen
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China
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Tian Jin
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China
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Tianjin
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China
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Wenzhou
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China
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Wuhan
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China
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Wuxi
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China
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Xi'an
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China
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Zhengzhou
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Czechia
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Brno
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Olomouc
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Czechia
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Ostrava - Poruba
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Czechia
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Praha 2
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Denmark
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Aalborg
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Denmark
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Aarhus
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Copenhagen
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Herning
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Denmark
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Odense C
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Denmark
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Vejle
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France
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AMIENS cedex 1
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France
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Caen cedex 9
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France
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Grenoble
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France
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Le Mans
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France
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Lille
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France
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Montpellier
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France
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Nantes Cedex 1
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France
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Paris
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France
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Toulouse
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France
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Vandœuvre-lès-Nancy
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Germany
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Cottbus
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Hamburg
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Germany
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Heidelberg
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Germany
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Marburg
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Germany
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Tübingen
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Germany
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Ulm
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Germany
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Zwickau
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Greece
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Athens Attica
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Greece
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Patra
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Greece
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Thessaloniki
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India
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Gurgaon
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India
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Pune
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Israel
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Hadera
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Israel
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Haifa
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Israel
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Petah Tikva
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Israel
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Ramat Gan
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Israel
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Tel Aviv-Yafo
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Italy
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Bologna
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Milano
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Italy
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Palermo
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Italy
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Pisa
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Italy
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Reggio Emilia
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Italy
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Roma
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Italy
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Siena
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Italy
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Turin
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Italy
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Udine
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Italy
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Varese
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Japan
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Bunkyo Ku
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Chiba
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Gifu
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Gunma
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Japan
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Hirakata
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Japan
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Hitachi
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Iruma-gun
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Japan
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Kamogawa City
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Japan
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Kashiwa
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Kurashiki
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Matsuyama
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Nagakute
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Niigata
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Okayama
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Osaka
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Sapporo
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Tokyo
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Yamanashi
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Malaysia
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Georgetown
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Subang Jaya
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Amersfoort
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Utrecht
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Lublin
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Almada
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Portugal
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Braga
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Lisbon
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Porto
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Portugal
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Vila Nova de Gaia
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Badalona
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Hospitalet de Llobregat
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Jerez de la Frontera
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Leon
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Madrid
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Murcia
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València
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Falun
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Helsingborg
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Uppsala
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Denizli
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Istanbul
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Aberdeen
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Birmingham
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Colchester
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Liverpool
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London
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Norwich
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Staffordshire
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Janssen Research & Development, LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd.
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Trial website
https://clinicaltrials.gov/study/NCT05572515
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Trial related presentations / publications
Query!
Public notes
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Contacts
Principal investigator
Name
0
0
Janssen Research & Development, LLC Clinical Trial
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Address
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0
Janssen Research & Development, LLC
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Country
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0
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Phone
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0
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Fax
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0
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Email
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0
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Contact person for public queries
Name
0
0
Study Contact
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Address
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0
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Country
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0
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Phone
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0
844-434-4210
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0
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Email
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0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05572515