Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007485

Trial Description

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Title

Phase 3 Study Comparing Daratumumab, Bortezomib and Dexamethasone (DVd) vs Bortezomib and Dexamethasone (Vd) in Subjects With Relapsed or Refractory Multiple Myeloma

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

This is an open-label (physicians and participants know the identity of the assigned
treatment), randomized (the study medication is assigned by chance), multicenter,
active-controlled study comparing daratumumab, VELCADE, and dexamethasone (DVd) with VELCADE
and dexamethasone (Vd) in participants with relapsed or refractory multiple myeloma.
Approximately 480 participants will be randomly assigned in a 1:1 ratio to receive either
DVd or Vd. Randomization will be stratified by International Staging System (ISS), number of
prior treatment programs (1 vs. 2 or 3 vs. >3), and prior VELCADE treatment ("no" vs.
"yes"). Within each stratum, participants will be randomized to one of the treatment
groups.The study will consist of a Screening Phase, a Treatment Phase, and a Follow-up
Phase. Participants will be treated until disease progression, unacceptable toxicity, or
other reasons to discontinue the study.

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Organizational Data

  •   DRKS00007485
  •   2015/01/20
  •   2014/05/01
  •   no
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Secondary IDs

  •   2014-000255-85 
  •   NCT02136134  (ClinicalTrials.gov)
  •   CR103995  (Janssen Research & Development, LLC)
  •   2014-000255-85 
  •   54767414MMY3004 
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Health Condition or Problem studied

  •   Multiple Myeloma
  •   C90.0 -  Multiple myeloma
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Interventions/Observational Groups

  •   Drug: Daratumumab
  •   Drug: VELCADE (Bortezomib)
  •   Drug: Dexamethasone
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- Percentage of participants with progression-free survival (PFS); time frame: Baseline, up to the end of the study, an expected average of 3 years; PFS is defined as a duration from the date of randomization to either progressive disease or death, whichever occurs first.

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Secondary Outcome

- Time to disease progression (TTP); time frame: Baseline, up to the end of the study, an expected average of 3 years; TTP is defined as the time from the date of randomization to the date of first documented evidence of progression, as defined in the International Myeloma Working Group (IMWG) criteria.
- Percentage of Participants With Overall Response; time frame: Baseline, up to the end of the study, an expected average of 3 years; The Overall Response is defined a stringent complete response (sCR), complete response, very good partial response (VGPR) or partial response (PR) as per IMWG Criteria.
- Duration of response; time frame: Baseline, up to the end of the study, an expected average of 3 years; Duration of response will be calculated from the date of initial documentation of a response to the date of first documented evidence of progressive disease, as defined in the IMWG criteria.
- Time to Response; time frame: Baseline, up to 9 weeks; Time to response is defined as the time from the date of first dose of study treatment to the date of the first documentation of observed response.
- Percentage of participants with a very good partial response (VGPR) or better; time frame: Baseline, up to the end of the study, an expected average of 3 years; VGPR is defined as a greater than 90% reduction in blood myeloma protein (M-protein) plus urine myeloma protein less than 100 mg per 24 hours.
- Percentage of participants with Minimal Residual Disease (MRD); time frame: Baseline, up to the end of the study, an expected average of 3 years; MRD will be assessed in participants who achieve ≥ VGPR by analyzing bone marrow aspiration specimens.
- Percentage of participants with overall survival (OS); time frame: Baseline, up to the end of the study, an expected average of 3 years; OS will be measured from the date of randomization to the date of the participant's death.

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Countries of Recruitment

  •   United States
  •   Australia
  •   Brazil
  •   Czech Republic
  •   Germany
  •   Hungary
  •   Korea, Republic of
  •   Mexico
  •   Netherlands
  •   Poland
  •   Russian Federation
  •   Spain
  •   Sweden
  •   Turkey
  •   Ukraine
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Locations of Recruitment

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Recruitment

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  •   2014/08/31
  •   480
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • Janssen Research & Development, LLC
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    • Janssen Research & Development, LLC
    • Janssen Research & Development, LLC Clinical trial 
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    • Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   6
  •   2015/05/04
* This entry means the parameter is not applicable or has not been set.