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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/NCT02136134




Registration number
NCT02136134
Ethics application status
Date submitted
1/05/2014
Date registered
12/05/2014
Date last updated
13/03/2024

Titles & IDs
Public title
Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma
Scientific title
Phase 3 Study Comparing Daratumumab, Bortezomib and Dexamethasone (DVd) vs Bortezomib and Dexamethasone (Vd) in Subjects With Relapsed or Refractory Multiple Myeloma
Secondary ID [1] 0 0
2014-000255-85
Secondary ID [2] 0 0
CR103995
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 - VELCADE (Bortezomib)
Treatment: Drugs - Dexamethasone

Experimental: Daratumumab+VELCADE+dexamethasone - Daratumumab, VELCADE and dexamethasone

Active Comparator: VELCADE+dexamethasone - VELCADE and dexamethasone.


Treatment: Drugs: Daratumumab
Daratumumab will be administered as an IV infusion or 16 mg/kg weekly for the first 3 cycles, on Day 1 of Cycles 4-9, and then every 4 weeks thereafter. As per protocol amendment-6 participants receiving treatment with daratumumab IV will have the option to switch to daratumumab SC 1800 mg on Day 1 of any cycle, at the discretion of the investigator.

Treatment: Drugs: VELCADE (Bortezomib)
VELCADE will be administered at a dose of 1.3 mg/m2 subcutaneously (SC) on Days 1, 4, 8 and 11 of each 21-day cycle. Eight VELCADE treatment cycles are to be administered.

Treatment: Drugs: Dexamethasone
Dexamethasone will be administered orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11 and 12 of the first 8 VELCADE treatment cycles.
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 the date of randomization to either progressive disease or death, whichever occurred first (approximately 1 year 4 months)
Secondary outcome [1] 0 0
Time to Disease Progression (TTP)
Timepoint [1] 0 0
From the date of randomization to the date of first documented evidence of progression or death due to PD whichever occurred first (approximately 6 years 9 months)
Secondary outcome [2] 0 0
Percentage of Participants With a Very Good Partial Response (VGPR) or Better
Timepoint [2] 0 0
Up to disease progression (approximately 6 years 9 months)
Secondary outcome [3] 0 0
Overall Response Rate (ORR)
Timepoint [3] 0 0
Up to disease progression (approximately 6 years 9 months)
Secondary outcome [4] 0 0
Percentage of Participants With Negative Minimal Residual Disease (MRD)
Timepoint [4] 0 0
Up to disease progression (approximately 6 years 9 months)
Secondary outcome [5] 0 0
Overall Survival (OS)
Timepoint [5] 0 0
Up to 6 years 9 months

Eligibility
Key inclusion criteria
- Must have had documented multiple myeloma

- Must have received at least 1 prior line of therapy for multiple myeloma

- Must have had documented evidence of progressive disease as defined based on
Investigator's determination of response of International Myeloma Working Group (IMWG)
criteria on or after their last regimen

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

- Must have achieved a response (partial response [PR] or better based on investigator's
determination of response by the IMWG criteria) to at least 1 prior regimen in the
past
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Has received daratumumab or other anti-CD38 therapies previously

- Is refractory to VELCADE or another PI, like ixazomib and carfilzomib (had progression
of disease while receiving VELCADE therapy or within 60 days of ending VELCADE therapy
or another PI therapy, like ixazomib and carfilzomib

- Is intolerant to VELCADE (ie, discontinued due to any adverse event while on VELCADE
treatment)

- Has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of
the treatment, whichever is longer, before the date of randomization. The only
exception is emergency use of a short course of corticosteroids (equivalent of
dexamethasone 40 milligram per day [mg/day] for a maximum of 4 days) before treatment.
A list of anti-myeloma treatments with the corresponding pharmacokinetic half-lives is
provided in the Site Investigational Product Procedures Manual (IPPM).

- Has a history of malignancy (other than multiple myeloma) within 3 years before the
date of randomization

- Has any concurrent medical condition or disease (eg, active systemic infection) that
is likely to interfere with study procedures

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/08/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/01/2024
Sample size
Target
Accrual to date
Final
498
Recruitment in Australia
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- Adelaide
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- Concord
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- Fitzroy
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- Melbourne
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- Nedlands
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- Woodville South
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- Adelaide
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- Concord
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- Fitzroy
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- Hobart
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- Melbourne
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- Nedlands
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- Woodville South
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Zaporizhzhya

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 assess the effects of administration of daratumumab when
combined with VELCADE (bortezomib) and dexamethasone compared with bortezomib and
dexamethasone alone, for participants with relapsed or refractory multiple myeloma.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02136134
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/NCT02136134