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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02252172




Registration number
NCT02252172
Ethics application status
Date submitted
11/08/2014
Date registered
30/09/2014
Date last updated
23/05/2024

Titles & IDs
Public title
Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma
Scientific title
A Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High Dose Therapy
Secondary ID [1] 0 0
54767414MMY3008
Secondary ID [2] 0 0
CR104762
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Daratumumab IV
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Daratumumab SC

Active Comparator: Lenalidomide and Dexamethasone (Rd) - Participants will receive Lenalidomide 25 mg capsule orally on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously once a week. Study treatment continues until disease progression, unacceptable toxicity, or end of study (maximum up to 7 years after last subject is randomized) whichever comes first.

Active Comparator: Daratumumab + Lenalidomide + Dexamethasone (DRd) - Participants will receive Daratumumab 16 milligram per kilogram (mg/kg) by intravenous infusion, once a week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks, Lenalidomide 25 mg capsule orally on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously once a week. Following implementation of protocol amendment 8, participants still receiving treatment with daratumumab IV will have the option to switch to daratumumab SC on Day 1 of any cycle, at the discretion of the investigator. Daratumumab subcutaneous (SC) will be administered by SC injection at a fixed dose of 1800 mg once every 4 weeks until documented progression, unacceptable toxicity, or study completion. Study treatment continues until disease progression, unacceptable toxicity, or end of study (maximum up to 7 years after last subject is randomized) whichever comes first.


Treatment: Drugs: Daratumumab IV
Daratumumab will be administered at a dose of 16 milligram per kilogram (mg/kg) by intravenous (IV) infusion, once a week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression of disease, unacceptable toxicity, or end of study (maximum up to 7 years).

Treatment: Drugs: Lenalidomide
Lenalidomide 25 mg capsule orally on Day 1 through Day 21 of each 28-day cycle.

Treatment: Drugs: Dexamethasone
Dexamethasone 40 mg orally or intravenously once in a week.

Treatment: Drugs: Daratumumab SC
Daratumumab SC will be administered by SC injection at a fixed dose of 1800 mg once every 4 weeks until documented progression, unacceptable toxicity, or study end. Following implementation of protocol amendment 8, participants still receiving treatment with daratumumab IV will have the option to switch to daratumumab SC on Day 1 of any cycle, at the discretion of the investigator.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary: Progression-free Survival (PFS)
Timepoint [1] 0 0
From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or clinical cut-off (CCO) whichever occurs first (up to 3.5 years)
Secondary outcome [1] 0 0
Percentage of Participants With Complete Response (CR) or Better
Timepoint [1] 0 0
From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)
Secondary outcome [2] 0 0
Percentage of Participants With Very Good Partial Response (VGPR) or Better
Timepoint [2] 0 0
From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)
Secondary outcome [3] 0 0
Percentage of Participants With Negative Minimal Residual Disease (MRD)
Timepoint [3] 0 0
From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)
Secondary outcome [4] 0 0
Overall Response Rate (ORR)
Timepoint [4] 0 0
From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)
Secondary outcome [5] 0 0
Overall Survival (OS)
Timepoint [5] 0 0
From randomization to death, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)
Secondary outcome [6] 0 0
Time to Disease Progression (TTP)
Timepoint [6] 0 0
From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)
Secondary outcome [7] 0 0
Time to Response
Timepoint [7] 0 0
From randomization to first response (PR or better) (up to 7.8 years)
Secondary outcome [8] 0 0
Duration of Response (DoR)
Timepoint [8] 0 0
From first response (PR of better) to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)
Secondary outcome [9] 0 0
Time to Subsequent Anti-myeloma Treatment
Timepoint [9] 0 0
From randomization to start of first subsequent anti-myeloma treatment, death, withdrawal of consent to study participation or CCO whichever is first (up to 7.8 years)
Secondary outcome [10] 0 0
Progression-free Survival on Next Line of Therapy (PFS2)
Timepoint [10] 0 0
From randomization to disease progression on first line of subsequent anti-myeloma therapy, death, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)
Secondary outcome [11] 0 0
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 Global Health Status Score to Day 1 of Cycle 3, 6, 9 and 12
Timepoint [11] 0 0
Baseline and Day 1 of Cycle 3, 6, 9 and 12 (each Cycle of 28 days)
Secondary outcome [12] 0 0
Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) to Day 1 of Cycle 3, 6, 9 and 12
Timepoint [12] 0 0
Baseline and Day 1 of Cycle 3, 6, 9 and 12 (each Cycle of 28 days)
Secondary outcome [13] 0 0
Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Utility Score to Day 1 of Cycle 3, 6, 9 and 12
Timepoint [13] 0 0
Baseline and Day 1 of Cycle 3, 6, 9 and 12 (each Cycle of 28 days)

Eligibility
Key inclusion criteria
- Participant must have documented multiple myeloma satisfying the CRAB (calcium
elevation, renal insufficiency, anemia and bone abnormalities) criteria, monoclonal
plasma cells in the bone marrow greater than or equal to (>=) 10 percent (%) or
presence of a biopsy proven plasmacytoma and measurable disease as defined by any of
the following: (a) immunoglobulin (Ig) G myeloma (serum monoclonal paraprotein
[M-protein] level >=1.0 gram/deciliter [g/dL] or urine M-protein level >=200
milligram[mg]/24 hours[hrs]; or (b) IgA, IgM, IgD, or IgE multiple myeloma (serum
M-protein level >=0.5 g/dL or urine M-protein level >=200 mg/24 hrs); or (c) light
chain multiple myeloma without measurable disease in serum or urine (serum
immunoglobulin free light chain >=10 mg/dL and abnormal serum immunoglobulin kappa
lambda free light chain ratio)

- Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status
score of 0, 1, or 2

- Participants who are newly diagnosed and not considered for high-dose chemotherapy due
to: being age >=65 years; or participants less than (<) 65 years with presence of
important comorbid condition(s) likely to have a negative impact on tolerability of
high dose chemotherapy with stem cell transplantation. Sponsor review and approval of
participants below 65 years of age is required before randomization

- Women of childbearing potential must commit to either abstain continuously from sexual
intercourse or to use 2 methods of reliable birth control simultaneously as deemed
appropriate by the Investigator. Contraception must begin 4 weeks prior to dosing and
must continue for 3 months after the last dose of daratumumab

- Man, who is sexually active with a woman of child-bearing potential must agree to use
a latex or synthetic condom, even if he had a successful vasectomy, must agree to use
an adequate contraception method as deemed appropriate by the Investigator, and must
also agree to not donate sperm during the study and for 4 weeks after last dose of
lenalidomide and 4 months after last dose of daratumumab
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participant has a diagnosis of primary amyloidosis, monoclonal gammopathy of
undetermined significance (presence of serum M-protein <3 g/dL; absence of lytic bone
lesions, anemia, hypercalcemia, and renal insufficiency related to the M-protein), or
smoldering multiple myeloma (asymptomatic multiple myeloma with absence of related
organ or tissue impairment end organ damage)

- Participant has a diagnosis of Waldenström's disease, or other conditions in which IgM
M protein is present in the absence of a clonal plasma cell infiltration with lytic
bone lesions

- Participant has a history of malignancy (other than multiple myeloma) within 5 years
before the date of randomization (exceptions are squamous and basal cell carcinomas of
the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the
Investigator, with concurrence with the Sponsor's medical monitor, is considered cured
with minimal risk of recurrence within 5 years)

- Participant has prior or current systemic therapy or SCT for multiple myeloma, with
the exception of an emergency use of a short course (equivalent of dexamethasone 40
mg/day for 4 days) of corticosteroids before treatment

- Participant has had radiation therapy within 14 days of randomization

- Participant has known chronic obstructive pulmonary disease (COPD) (defined as a
forced expiratory volume in 1 second [FEV1] <50% of predicted normal), persistent
asthma, or a history of asthma within the last 2 years (controlled intermittent asthma
or controlled mild persistent asthma is allowed)

- Participants with known or suspected COPD must have a FEV1 test during Screening

- Participant is known to be seropositive for human immunodeficiency virus (HIV) or
hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg] or
antibodies to hepatitis B surface and core antigens [anti-HBs and anti-HBc,
respectively]) or hepatitis C (anti-HCV antibody positive or HCV-ribonucleic acid
[RNA] quantitation positive)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/02/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/06/2024
Actual
Sample size
Target
Accrual to date
Final
737
Recruitment in Australia
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- Box Hill
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- Fitzroy
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- Footscray
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- Kogarah
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- Kurralta Park
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- Nedlands
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- New South Wales
Recruitment hospital [8] 0 0
- Woodville
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- Woolloongabba N/a
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- Box Hill
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- Fitzroy
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- Footscray
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- Kogarah
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- Kurralta Park
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- Nedlands
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- New South Wales
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- Woodville
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- Woolloongabba N/a
Recruitment outside Australia
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Germany
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Halmstad
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Helsingborg
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Huddinge
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Lulea
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Lund
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Stockholm
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Sweden
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Örebro
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United Kingdom
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Aberdeen
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Canterbury
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Dundee
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Leeds
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London
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Manchester
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Nottingham
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United Kingdom
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Oxford
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Plymouth, Devon
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Southampton
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Truro
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United Kingdom
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to compare the efficacy of daratumumab in combination with
lenalidomide and dexamethasone to that of lenalidomide and dexamethasone in terms of
progression-free survival (PFS) in participants with newly diagnosed multiple myeloma (a
blood cancer of plasma cells) who are not candidates for high dose chemotherapy (treatment of
disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT).
Trial website
https://clinicaltrials.gov/ct2/show/NCT02252172
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02252172