Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05730036
Registration number
NCT05730036
Ethics application status
Date submitted
6/02/2023
Date registered
15/02/2023
Titles & IDs
Public title
A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma
Query!
Scientific title
An Open-label, Randomized, Phase 3 Study of Linvoseltamab (REGN5458; Anti- BCMA x Anti-CD3 Bispecific Antibody) Versus the Combination of Elotuzumab, Pomalidomide, and Dexamethasone (EPd), in Patients With Relapsed/Refractory Multiple Myeloma (LINKER-MM3)
Query!
Secondary ID [1]
0
0
2022-501396-62-00
Query!
Secondary ID [2]
0
0
R5458-ONC-2245
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
LINKER-MM3
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Relapsed Refractory Multiple Myeloma (RRMM)
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Other cancer types
Query!
Intervention/exposure
Study type
Interventional(has expanded access)
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Linvoseltamab
Treatment: Drugs - Elotuzumab
Treatment: Drugs - Pomalidomide
Treatment: Drugs - Dexamethasone
Experimental: Linvoseltamab - Randomization 1:1
Active comparator: Elotuzumab/Pomalidomide/Dexamethasone (EPd) - Randomization 1:1
Treatment: Drugs: Linvoseltamab
REGN5458 will be administered by intravenous (IV) infusion
Treatment: Drugs: Elotuzumab
Elotuzumab will be administered by IV infusion
Treatment: Drugs: Pomalidomide
Pomalidomide capsules will administered by mouth (PO)
Treatment: Drugs: Dexamethasone
Dexamethasone tablets/capsules will be administered PO and/or by IV infusion
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Progression Free Survival (PFS) per International Myeloma Working Group (IMWG) response criteria determined by Independent Review Committee (IRC) in CD38 antibody exposed participants
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [1]
0
0
PFS per IMWG response criteria determined by IRC in all participants
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [2]
0
0
Objective Response (OR) of Partial Response (PR) or better per IMWG response criteria as determined by the IRC in CD38 antibody exposed participants
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [3]
0
0
OR of PR or better per IMWG response criteria as determined by the IRC in all participants
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [4]
0
0
OR of Very Good Partial Response (VGPR) or better per IMWG response criteria as determined by IRC in CD38 antibody exposed participants
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [5]
0
0
OR of VGPR or better per IMWG response criteria as determined by IRC in all participants
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [6]
0
0
OR of Complete Response (CR) or better per IMWG response criteria as determined by IRC in CD38 antibody exposed participants
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [7]
0
0
OR of CR or better per IMWG response criteria as determined by IRC in all participants
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [8]
0
0
Incidence of minimal residual disease (MRD) negative status in participants previously exposed to CD38 antibodies
Query!
Assessment method [8]
0
0
Query!
Timepoint [8]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [9]
0
0
Incidence of MRD negative status in all participants
Query!
Assessment method [9]
0
0
Query!
Timepoint [9]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [10]
0
0
Overall Survival (OS) in participants previously exposed to CD38 antibodies
Query!
Assessment method [10]
0
0
Query!
Timepoint [10]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [11]
0
0
OS in all participants
Query!
Assessment method [11]
0
0
Query!
Timepoint [11]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [12]
0
0
Mean change in the worst pain score measured by Brief Pain Inventory-Short Form (BPI-SF) Item 3 in participants previously exposed to CD38 antibodies
Query!
Assessment method [12]
0
0
The BPI-SF is a validated, self-administered questionnaire designed to measure a participant's perceived level of pain. The BPI-SF Item 3 uses a numeric rating scale to assess pain severity and pain interference in the past 24 hours. The numeric rating scale ranges from 0 (no pain) to 10 (worst imaginable pain), where higher scores indicate greater intensity of pain.
Query!
Timepoint [12]
0
0
Baseline to week 12
Query!
Secondary outcome [13]
0
0
Mean change in the worst pain score measured by BPI-SF Item 3 in all participants
Query!
Assessment method [13]
0
0
The BPI-SF is a validated, self-administered questionnaire designed to measure a participant's perceived level of pain. The BPI-SF Item 3 uses a numeric rating scale to assess pain severity and pain interference in the past 24 hours. The numeric rating scale ranges from 0 (no pain) to 10 (worst imaginable pain), where higher scores indicate greater intensity of pain.
Query!
Timepoint [13]
0
0
Baseline to week 12
Query!
Secondary outcome [14]
0
0
Incidence of treatment emergent adverse events (TEAEs) in participants previously exposed to CD38 antibodies
Query!
Assessment method [14]
0
0
Query!
Timepoint [14]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [15]
0
0
Incidence TEAEs in all participants
Query!
Assessment method [15]
0
0
Query!
Timepoint [15]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [16]
0
0
Severity of TEAEs in participants previously exposed to CD38 antibodies
Query!
Assessment method [16]
0
0
Query!
Timepoint [16]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [17]
0
0
Severity of TEAEs in all participants
Query!
Assessment method [17]
0
0
Query!
Timepoint [17]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [18]
0
0
Incidence of adverse events of special interest (AESI) in participants previously exposed to CD38 antibodies
Query!
Assessment method [18]
0
0
Query!
Timepoint [18]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [19]
0
0
Incidence of AESI in all participants
Query!
Assessment method [19]
0
0
Query!
Timepoint [19]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [20]
0
0
Severity of AESI in participants previously exposed to CD38 antibodies
Query!
Assessment method [20]
0
0
Query!
Timepoint [20]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [21]
0
0
Severity AESI in all participants
Query!
Assessment method [21]
0
0
Query!
Timepoint [21]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [22]
0
0
Incidence of Serious Adverse Events (SAE) in participants previously exposed to CD38 antibodies
Query!
Assessment method [22]
0
0
Query!
Timepoint [22]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [23]
0
0
Incidence of SAE in all participants
Query!
Assessment method [23]
0
0
Query!
Timepoint [23]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [24]
0
0
Severity of SAE in participants previously exposed to CD38 antibodies
Query!
Assessment method [24]
0
0
Query!
Timepoint [24]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [25]
0
0
Severity of SAE in all participants
Query!
Assessment method [25]
0
0
Query!
Timepoint [25]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [26]
0
0
PFS per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies
Query!
Assessment method [26]
0
0
Query!
Timepoint [26]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [27]
0
0
PFS per IMWG response criteria as determined by the investigator in all participants
Query!
Assessment method [27]
0
0
Query!
Timepoint [27]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [28]
0
0
OR of PR or better per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies
Query!
Assessment method [28]
0
0
Query!
Timepoint [28]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [29]
0
0
OR of PR or better per IMWG response criteria as determined by the investigator in all participants
Query!
Assessment method [29]
0
0
Query!
Timepoint [29]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [30]
0
0
OR of VGPR or better per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies
Query!
Assessment method [30]
0
0
Query!
Timepoint [30]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [31]
0
0
OR of VGPR or better per IMWG response criteria as determined by the investigator in all participants
Query!
Assessment method [31]
0
0
Query!
Timepoint [31]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [32]
0
0
OR of CR or better per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies
Query!
Assessment method [32]
0
0
Query!
Timepoint [32]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [33]
0
0
OR of CR or better per IMWG response criteria as determined by the investigator in all participants
Query!
Assessment method [33]
0
0
Query!
Timepoint [33]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [34]
0
0
Duration of Response (DoR) as per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies
Query!
Assessment method [34]
0
0
Query!
Timepoint [34]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [35]
0
0
DoR as per IMWG response criteria as determined by the investigator in all participants
Query!
Assessment method [35]
0
0
Query!
Timepoint [35]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [36]
0
0
DoR as per IMWG response criteria as determined by the IRC in participants previously exposed to CD38 antibodies
Query!
Assessment method [36]
0
0
Query!
Timepoint [36]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [37]
0
0
DoR as per IMWG response criteria as determined by the IRC in all participants
Query!
Assessment method [37]
0
0
Query!
Timepoint [37]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [38]
0
0
Duration of MRD negative status in the bone marrow in participants previously exposed to CD38 antibodies
Query!
Assessment method [38]
0
0
Query!
Timepoint [38]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [39]
0
0
Duration of MRD negative status in the bone marrow in all participants
Query!
Assessment method [39]
0
0
Query!
Timepoint [39]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [40]
0
0
Time from randomization to objective response (=PR) as per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies
Query!
Assessment method [40]
0
0
Query!
Timepoint [40]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [41]
0
0
Time from randomization to objective response (=PR) as per IMWG response criteria as determined by the investigator in all participants
Query!
Assessment method [41]
0
0
Query!
Timepoint [41]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [42]
0
0
Time from randomization to objective response (=PR) as per IMWG response criteria as determined by the IRC in participants previously exposed to CD38 antibodies
Query!
Assessment method [42]
0
0
Query!
Timepoint [42]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [43]
0
0
Time from randomization to objective response (=PR) as per IMWG response criteria as determined by the IRC in all participants
Query!
Assessment method [43]
0
0
Query!
Timepoint [43]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [44]
0
0
Concentration of linvoseltamab in the serum over time in participants previously exposed to CD38 antibodies
Query!
Assessment method [44]
0
0
Query!
Timepoint [44]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [45]
0
0
Concentration of linvoseltamab in the serum over time in all participants
Query!
Assessment method [45]
0
0
Query!
Timepoint [45]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [46]
0
0
Incidence of antidrug antibodies (ADAs) in participants previously exposed to CD38 antibodies
Query!
Assessment method [46]
0
0
Query!
Timepoint [46]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [47]
0
0
Incidence of ADAs in all participants
Query!
Assessment method [47]
0
0
Query!
Timepoint [47]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [48]
0
0
Titer of ADAs in participants previously exposed to CD38 antibodies
Query!
Assessment method [48]
0
0
Query!
Timepoint [48]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [49]
0
0
Titer of ADAs in all participants
Query!
Assessment method [49]
0
0
Query!
Timepoint [49]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [50]
0
0
Incidence of neutralizing antibodies (Nabs) to linvoseltamab over time in participants previously exposed to CD38 antibodies
Query!
Assessment method [50]
0
0
Query!
Timepoint [50]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [51]
0
0
Incidence of Nabs to linvoseltamab over time in all participants
Query!
Assessment method [51]
0
0
Query!
Timepoint [51]
0
0
Up to approximatively 5 years
Query!
Secondary outcome [52]
0
0
Proportion of Pain Responders in participants previously exposed to CD38 antibodies
Query!
Assessment method [52]
0
0
Defined by at least a 2-point reduction from baseline in the BPI-SF Item 3 without an increase in analgesic use using the modified Analgesic Quantification Algorithm (AQA).
Query!
Timepoint [52]
0
0
At week 12
Query!
Secondary outcome [53]
0
0
Proportion of Pain Responders in all participants
Query!
Assessment method [53]
0
0
Defined by at least a 2-point reduction from baseline in the BPI-SF Item 3 without an increase in analgesic use using the modified Analgesic Quantification Algorithm (AQA).
Query!
Timepoint [53]
0
0
At week 12
Query!
Secondary outcome [54]
0
0
Change in patient-reported global health status/quality of life (QoL), per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in participants previously exposed to CD38 antibodies
Query!
Assessment method [54]
0
0
The EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional Scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much."
Query!
Timepoint [54]
0
0
Baseline to week 12
Query!
Secondary outcome [55]
0
0
Change in patient-reported QoL, per EORTC QLQ-C30 in all participants
Query!
Assessment method [55]
0
0
The EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional Scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much."
Query!
Timepoint [55]
0
0
Baseline to week 12
Query!
Secondary outcome [56]
0
0
Change in patient reported disease symptoms per EORTC Quality of Life Questionnaire-Multiple Myeloma (MM) module 20 [QLQ-MY20]) in participants previously exposed to CD38 antibodies
Query!
Assessment method [56]
0
0
The EORTC QLQ-MY20 is a self -administered instrument to assess QoL in persons with MM. This 20-item questionnaire measures the following domains: symptom scales, including disease symptoms (6 items) and symptoms related to side effects of treatment (10 items); function scale and future perspective (3 items); and body image (1 item). A high score represents a high level of symptoms or problems.
Query!
Timepoint [56]
0
0
Baseline to week 12
Query!
Secondary outcome [57]
0
0
Change in patient reported disease symptoms per EORTC QLQ-MY20 in all participants
Query!
Assessment method [57]
0
0
The EORTC QLQ-MY20 is a self -administered instrument to assess QoL in persons with MM. This 20-item questionnaire measures the following domains: symptom scales, including disease symptoms (6 items) and symptoms related to side effects of treatment (10 items); function scale and future perspective (3 items); and body image (1 item). A high score represents a high level of symptoms or problems.
Query!
Timepoint [57]
0
0
Baseline to week 12
Query!
Secondary outcome [58]
0
0
Patient-Reported Outcomes in Patient Global Impression of Symptom Severity (PGIS) in participants previously exposed to CD38 antibodies
Query!
Assessment method [58]
0
0
The PGIS is a single 1-item questionnaire designed to assess participant's overall impression of disease severity at a given point in time by using a 4-point Likert scale that ranges from (1) = "none (no symptoms)" to (4) = "severe".
The global anchor, PGIS will be used for interpretation of EORTC QLQ-C30, EORTC QLQ-MY20, and BPI-SF.
Query!
Timepoint [58]
0
0
Baseline to week 12
Query!
Secondary outcome [59]
0
0
Patient-Reported Outcomes in PGIS in all participants
Query!
Assessment method [59]
0
0
The PGIS is a single 1-item questionnaire designed to assess participant's overall impression of disease severity at a given point in time by using a 4-point Likert scale that ranges from (1) = "none (no symptoms)" to (4) = "severe".
The global anchor, PGIS will be used for interpretation of EORTC QLQ-C30, EORTC QLQ-MY20, and BPI-SF.
Query!
Timepoint [59]
0
0
Baseline to week 12
Query!
Secondary outcome [60]
0
0
Patient-Reported Outcomes in Patient Global Impression of Change (PGIC) in participants previously exposed to CD38 antibodies
Query!
Assessment method [60]
0
0
The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change since starting treatment as rated on a 5-point Likert scale anchored by (1) "much better" to (5) "much worse", with (4) = "no change".
The global anchor, PGIC will be used for interpretation of EORTC QLQ-C30, EORTC QLQ-MY20, and BPI-SF.
Query!
Timepoint [60]
0
0
Baseline to week 12
Query!
Secondary outcome [61]
0
0
Patient-Reported Outcomes in PGIC in all participants
Query!
Assessment method [61]
0
0
The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change since starting treatment as rated on a 5-point Likert scale anchored by (1) "much better" to (5) "much worse", with (4) = "no change".
The global anchor, PGIC will be used for interpretation of EORTC QLQ-C30, EORTC QLQ-MY20, and BPI-SF.
Query!
Timepoint [61]
0
0
Baseline to week 12
Query!
Secondary outcome [62]
0
0
Change in patient-reported general health status per EuroQoL-5 Dimension-5 Level Scale [EQ-5D-5L]) in participants previously exposed to CD38 antibodies
Query!
Assessment method [62]
0
0
The EQ-5D-5L consists of EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Query!
Timepoint [62]
0
0
Baseline to week 12
Query!
Secondary outcome [63]
0
0
Change in patient-reported general health status per EQ-5D-5L in all participants
Query!
Assessment method [63]
0
0
The EQ-5D-5L consists of EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Query!
Timepoint [63]
0
0
Baseline to week 12
Query!
Eligibility
Key inclusion criteria
Key
1. Age 18 years or older (or legal adult age in the country) at the time of the screening visit.
2. Eastern Cooperative Oncology Group (ECOG) performance status =1. Patients with ECOG 2 solely due to local symptoms of myeloma (eg. pain) may be allowed after discussion with the Medical Monitor.
3. Received at least 1 and no more than 4 prior lines of anti-neoplastic MM therapies, including lenalidomide and a proteasome inhibitor and demonstrated disease progression on or after the last therapy as defined by the 2016 IMWG criteria. Participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory, as described in the protocol.
Note: Participants in Israel also must have previously received a CD38 antibody. Participants in the EU and the UK must have previously received 2 to 4 prior lines of therapy, including a CD38 antibody.
4. Patients must have measurable disease for response assessment as per the 2016 IMWG response assessment criteria, as described in the protocol
5. Adequate hematologic, hepatic, renal and cardiac function, as well as evidence of adequate bone marrow reserves
6. Life expectancy of at least 6 months
Key
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Diagnosis of plasma cell leukemia, amyloidosis, Waldenström macroglobulinemia, or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
2. Prior treatment with elotuzumab and/or pomalidomide
3. Participants with known MM brain lesions or meningeal involvement
4. Treatment with any systemic anti-cancer therapy within 5 half-lives or within 28 days before first administration of study drug, whichever is shorter
5. History of allogeneic stem cell transplantation within 6 months, or autologous stem cell transplantation within 12 weeks of the start of study treatment. Participants who have received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease. Steroids at doses equivalent to suppletion doses may be acceptable.
6. Prior treatment with B-cell maturation antigen (BCMA) directed immunotherapies Note: BCMA antibody-drug conjugates are allowed.
7. History of progressive multifocal leukoencephalopathy (PML), known or suspected PML, or history of a neurocognitive condition or central nervous system (CNS) movement disorder.
8. Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first administration of study drug
9. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); or another uncontrolled infection, as defined in the protocol.
NOTE: Other protocol defined inclusion/exclusion criteria apply
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
18/09/2023
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
26/12/2032
Query!
Actual
Query!
Sample size
Target
380
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Query!
Recruitment hospital [1]
0
0
Royal Prince Alfred Hospital - Camperdown
Query!
Recruitment hospital [2]
0
0
Royal North Shore Hospital - St Leonards
Query!
Recruitment hospital [3]
0
0
Royal Brisbane Hospital - Herston
Query!
Recruitment hospital [4]
0
0
Integrated Clinical Oncology Network - South Brisbane
Query!
Recruitment hospital [5]
0
0
Royal Adelaide hospital - Adelaide
Query!
Recruitment hospital [6]
0
0
Launceston General Hospital - Launceston
Query!
Recruitment hospital [7]
0
0
University Hospital Geelong - Geelong
Query!
Recruitment hospital [8]
0
0
Austin Hospital - Heidelberg
Query!
Recruitment hospital [9]
0
0
St Vincents Hospital Melbourne - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [3]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [4]
0
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [5]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [6]
0
0
7250 - Launceston
Query!
Recruitment postcode(s) [7]
0
0
3220 - Geelong
Query!
Recruitment postcode(s) [8]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [9]
0
0
3065 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Florida
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Kentucky
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
New York
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
North Carolina
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Oregon
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Washington
Query!
Country [8]
0
0
Belgium
Query!
State/province [8]
0
0
West-Vlaanderen
Query!
Country [9]
0
0
Brazil
Query!
State/province [9]
0
0
Bahia
Query!
Country [10]
0
0
Brazil
Query!
State/province [10]
0
0
Rio Grade Do Sul
Query!
Country [11]
0
0
Brazil
Query!
State/province [11]
0
0
Rio Grande Do Sul
Query!
Country [12]
0
0
Brazil
Query!
State/province [12]
0
0
Santa Catarina
Query!
Country [13]
0
0
Brazil
Query!
State/province [13]
0
0
Curitiba
Query!
Country [14]
0
0
Brazil
Query!
State/province [14]
0
0
Porto Alegre
Query!
Country [15]
0
0
Brazil
Query!
State/province [15]
0
0
Rio de Janeiro
Query!
Country [16]
0
0
Brazil
Query!
State/province [16]
0
0
São Paulo
Query!
Country [17]
0
0
Canada
Query!
State/province [17]
0
0
Ontario
Query!
Country [18]
0
0
Chile
Query!
State/province [18]
0
0
Santiago
Query!
Country [19]
0
0
France
Query!
State/province [19]
0
0
Gironde
Query!
Country [20]
0
0
France
Query!
State/province [20]
0
0
Paris
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Lille
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Lyon
Query!
Country [23]
0
0
Germany
Query!
State/province [23]
0
0
Baden-Wuerttemberg
Query!
Country [24]
0
0
Germany
Query!
State/province [24]
0
0
Hamburg
Query!
Country [25]
0
0
Israel
Query!
State/province [25]
0
0
Hamerkaz
Query!
Country [26]
0
0
Israel
Query!
State/province [26]
0
0
Haifa
Query!
Country [27]
0
0
Israel
Query!
State/province [27]
0
0
Jerusalem
Query!
Country [28]
0
0
Israel
Query!
State/province [28]
0
0
Tel Aviv
Query!
Country [29]
0
0
Italy
Query!
State/province [29]
0
0
Foggia
Query!
Country [30]
0
0
Italy
Query!
State/province [30]
0
0
Forli Cesena
Query!
Country [31]
0
0
Italy
Query!
State/province [31]
0
0
Lombardy
Query!
Country [32]
0
0
Italy
Query!
State/province [32]
0
0
Alessandria
Query!
Country [33]
0
0
Italy
Query!
State/province [33]
0
0
Ancona
Query!
Country [34]
0
0
Italy
Query!
State/province [34]
0
0
Bologna
Query!
Country [35]
0
0
Italy
Query!
State/province [35]
0
0
Genova
Query!
Country [36]
0
0
Italy
Query!
State/province [36]
0
0
Pavia
Query!
Country [37]
0
0
Italy
Query!
State/province [37]
0
0
Ravenna
Query!
Country [38]
0
0
Italy
Query!
State/province [38]
0
0
Reggio Emilia
Query!
Country [39]
0
0
Italy
Query!
State/province [39]
0
0
Torino
Query!
Country [40]
0
0
Italy
Query!
State/province [40]
0
0
Turin
Query!
Country [41]
0
0
Italy
Query!
State/province [41]
0
0
Viagrande
Query!
Country [42]
0
0
Korea, Republic of
Query!
State/province [42]
0
0
Busan
Query!
Country [43]
0
0
Korea, Republic of
Query!
State/province [43]
0
0
Hwasun
Query!
Country [44]
0
0
Korea, Republic of
Query!
State/province [44]
0
0
Incheon
Query!
Country [45]
0
0
Korea, Republic of
Query!
State/province [45]
0
0
Jeonju
Query!
Country [46]
0
0
Korea, Republic of
Query!
State/province [46]
0
0
Seoul
Query!
Country [47]
0
0
Netherlands
Query!
State/province [47]
0
0
Gelderland
Query!
Country [48]
0
0
Netherlands
Query!
State/province [48]
0
0
Zuid-Holland
Query!
Country [49]
0
0
Poland
Query!
State/province [49]
0
0
Lodzkie
Query!
Country [50]
0
0
Poland
Query!
State/province [50]
0
0
Pomorskie
Query!
Country [51]
0
0
Poland
Query!
State/province [51]
0
0
Katowice
Query!
Country [52]
0
0
Singapore
Query!
State/province [52]
0
0
Kent Ridge
Query!
Country [53]
0
0
Singapore
Query!
State/province [53]
0
0
Singapore
Query!
Country [54]
0
0
Spain
Query!
State/province [54]
0
0
Asturias
Query!
Country [55]
0
0
Spain
Query!
State/province [55]
0
0
Baleares
Query!
Country [56]
0
0
Spain
Query!
State/province [56]
0
0
Barcelona
Query!
Country [57]
0
0
Spain
Query!
State/province [57]
0
0
Cantabria
Query!
Country [58]
0
0
Spain
Query!
State/province [58]
0
0
Islas Baleares
Query!
Country [59]
0
0
Spain
Query!
State/province [59]
0
0
Madrid
Query!
Country [60]
0
0
Spain
Query!
State/province [60]
0
0
Navarra
Query!
Country [61]
0
0
Spain
Query!
State/province [61]
0
0
Alicante
Query!
Country [62]
0
0
Spain
Query!
State/province [62]
0
0
Girona
Query!
Country [63]
0
0
Spain
Query!
State/province [63]
0
0
Leon
Query!
Country [64]
0
0
Spain
Query!
State/province [64]
0
0
Malaga
Query!
Country [65]
0
0
Spain
Query!
State/province [65]
0
0
Santiago de Compostela
Query!
Country [66]
0
0
Spain
Query!
State/province [66]
0
0
Seville
Query!
Country [67]
0
0
Spain
Query!
State/province [67]
0
0
Valencia
Query!
Country [68]
0
0
Spain
Query!
State/province [68]
0
0
Vitoria-Gasteiz
Query!
Country [69]
0
0
Spain
Query!
State/province [69]
0
0
Zaragoza
Query!
Country [70]
0
0
Taiwan
Query!
State/province [70]
0
0
Changhua County
Query!
Country [71]
0
0
Taiwan
Query!
State/province [71]
0
0
Hualien City
Query!
Country [72]
0
0
Taiwan
Query!
State/province [72]
0
0
Kaohsiung
Query!
Country [73]
0
0
Taiwan
Query!
State/province [73]
0
0
Tainan
Query!
Country [74]
0
0
Taiwan
Query!
State/province [74]
0
0
Taipei
Query!
Country [75]
0
0
Taiwan
Query!
State/province [75]
0
0
Taoyuan
Query!
Country [76]
0
0
United Kingdom
Query!
State/province [76]
0
0
Scotland
Query!
Country [77]
0
0
United Kingdom
Query!
State/province [77]
0
0
Surrey
Query!
Country [78]
0
0
United Kingdom
Query!
State/province [78]
0
0
West Midlands
Query!
Country [79]
0
0
United Kingdom
Query!
State/province [79]
0
0
Cambridge
Query!
Country [80]
0
0
United Kingdom
Query!
State/province [80]
0
0
London
Query!
Country [81]
0
0
United Kingdom
Query!
State/province [81]
0
0
Manchester
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Regeneron Pharmaceuticals
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study is researching an experimental drug called linvoseltamab, also called REGN5458. Linvoseltamab has previously been studied by itself (without other cancer drugs) in participants who had advanced multiple myeloma that returned and needed to be treated again after many other therapies had failed. These participants were no longer benefiting from standard medications and had no good treatment options. In that study, some participants who were treated with linvoseltamab had improvement of their myeloma (shrinkage of their tumors), including some participants who had complete responses (that is, the treatment got rid of all evidence of myeloma in their bodies). This study is focused on participants who have multiple myeloma that has returned or needs to be treated again after one to four prior treatments and have standard cancer treatment options available to them. The aim of this study is to see how safe and effective linvoseltamab is compared to a combination of three cancer drugs: elotuzumab, pomalidomide and dexamethasone, (called EPd) in participants who have returned after having received prior treatment that included lenalidomide, a proteosome inhibitor, and (for participants in some countries) a cluster of differentiation 38 (CD38) antibody. Half of the participants in this study will get linvoseltamab, and the other half will get EPd. This study is looking at several other research questions, including: * How long participants benefit from receiving linvoseltamab compared with EPd * How many participants treated with linvoseltamab or EPd have improvement of their multiple myeloma and by how much * What side effects happen from taking linvoseltamab compared to EPd * How long participants live while receiving treatment or after treatment with linvoseltamab compared to EPd * If there is any improvement in pain after treatment with linvoseltamab compared to EPd
Query!
Trial website
https://clinicaltrials.gov/study/NCT05730036
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Clinical Trial Management
Query!
Address
0
0
Regeneron Pharmaceuticals
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Clinical Trials Administrator
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
844-734-6643
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
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?
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
Query!
When will data be available (start and end dates)?
When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
Query!
Available to whom?
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://vivli.org/
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/NCT05730036