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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/NCT02076009




Registration number
NCT02076009
Ethics application status
Date submitted
27/02/2014
Date registered
3/03/2014
Date last updated
23/05/2024

Titles & IDs
Public title
A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma
Scientific title
Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed or Refractory Multiple Myeloma
Secondary ID [1] 0 0
54767414MMY3003
Secondary ID [2] 0 0
CR103663
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
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Dexamethasone

Experimental: Daratumumab + lenalidomide + dexamethasone - During each 28-day treatment cycle, participants will receive daratumumab, lenalidomide, and dexamethasone.

Active Comparator: Lenalidomide + dexamethasone - During each 28-day treatment cycle, participants will receive lenalidomide and dexamethasone.


Treatment: Drugs: Daratumumab
Daratumumab 16mg/kg will be administered as an intravenous (IV) infusion (into the vein) as per the following schedule: once a week during treatment cycles 1 and 2; every 2 weeks during treatment cycles 3 to 6; and every 4 weeks for cycles 7 and onwards. Following amendment 8, participants receiving daratumumab IV have the option to switch to daratumumab subcutaneous (SC) 1800 mg/dose until documented progression, unacceptable toxicity, or the end of study on Day 1 of any cycle, at the discretion of the investigator.

Treatment: Drugs: Lenalidomide
Lenalidomide will be administered at a dose of 25 mg orally (by mouth) on Days 1 through 21 of each treatment cycle.

Treatment: Drugs: Dexamethasone
Dexamethasone (or equivalent in accordance with local standards) will be administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 18.5).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS)
Timepoint [1] 0 0
From randomization to either disease progression or death whichever occurs first (up to 21 months)
Secondary outcome [1] 0 0
Time to Disease Progression (TTP)
Timepoint [1] 0 0
From randomization to disease progression (up to 21 months)
Secondary outcome [2] 0 0
Percentage of Participants Who Achieved Very Good Partial Response (VGPR) or Better
Timepoint [2] 0 0
From randomization to disease progression (up to 21 months)
Secondary outcome [3] 0 0
Percentage of Participants With Negative Minimal Residual Disease (MRD)
Timepoint [3] 0 0
From randomization to the date of first documented evidence of PD (up to 87.5 months)
Secondary outcome [4] 0 0
Overall Response Rate
Timepoint [4] 0 0
From randomization to disease progression (up to 21 months)
Secondary outcome [5] 0 0
Overall Survival (OS)
Timepoint [5] 0 0
From randomization to date of death due to any cause (up to 87.5 months)
Secondary outcome [6] 0 0
Time to Response
Timepoint [6] 0 0
From randomization up to first documented CR or PR (up to 21 months)
Secondary outcome [7] 0 0
Duration of Response (DOR)
Timepoint [7] 0 0
From randomization to the date of first documented evidence of PD (up to 21 months)
Secondary outcome [8] 0 0
Time to Subsequent Anticancer Treatment
Timepoint [8] 0 0
From randomization to date of start of subsequent anticancer treatment or death due to PD, whichever occured first (up to 87.5 months)

Eligibility
Key inclusion criteria
- Must have documented multiple myeloma and measurable disease

- Must have received at least 1 prior line of therapy for multiple myeloma and achieved
a response (partial response or better) to at least one prior regimen

- Must have documented evidence of progressive disease as defined by the International
Myeloma Working Group criteria on or after their last regimen

- Must have an Eastern Cooperative Oncology Group Performance Status score of 0, 1, or 2

- If a participant has received subsequent anticancer therapy (salvage therapy), the
participant must have a "wash-out period" defined as 2 weeks or 5 pharmacokinetic
half-lives of the treatment, whichever is longer, before the planned start date of
daratumumab monotherapy. The only exception is the emergency use of a short course of
corticosteroids (equivalent of dexamethasone 40 milligram per day for a maximum of 4
days) before Daratumumab monotherapy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Has received any of the following therapies: daratumumab or other anti-CD38 therapies

- Has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of
the treatment

- Disease shows evidence of refractoriness or intolerance to lenalidomide or if
previously treated with a lenalidomide-containing regimen the participant is excluded
if he or she discontinued due to any adverse event related to prior lenalidomide
treatment

- Has received autologous stem cell transplantation within 12 weeks before the date of
randomization, or previously received an allogenic stem cell transplant (regardless of
timing), or planning to undergo a stem cell transplant prior to progression of disease

- History of malignancy (other than multiple myeloma) within 5 years before the first
dose of daratumumab monotherapy (exceptions are squamous and basal cell carcinomas of
the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion,
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)

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
23/05/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/08/2024
Actual
Sample size
Target
Accrual to date
Final
569
Recruitment in Australia
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- Camperdown
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- Geelong
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- Heidelberg
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- South Brisbane
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- Southport
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- Camperdown
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- Geelong
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- Heidelberg
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- Malvern
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- South Brisbane
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- Southport
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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 effectiveness of daratumumab when combined with
lenalidomide and dexamethasone (DRd) to that of lenalidomide and dexamethasone (Rd), in terms
of progression-free survival in participants with relapsed or refractory multiple myeloma.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02076009
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/NCT02076009