Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
Multiple Myeloma, Plasmacytoma, Refractory Multiple Myeloma, Relapsed Multiple Myeloma, Daratumumab, VELCADE
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Daratumumab Type: Drug
Name: VELCADE (Bortezomib) Type: Drug
Name: Dexamethasone Type: Drug
Overall Status
Recruiting
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.
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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

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
Locations
Birmingham, Alabama, United States
Status: Recruiting
La Jolla, California, United States
Status: Withdrawn
Los Angeles, California, United States
Status: Recruiting
Los Angeles, California, United States
Status: Withdrawn
San Diego, California, United States
Status: Withdrawn
Stamford, Connecticut, United States
Status: Recruiting
Washington, District of Columbia, United States
Status: Withdrawn
Gainesville, Florida, United States
Status: Withdrawn
Jacksonville, Florida, United States
Status: Recruiting
Orlando, Florida, United States
Status: Withdrawn
Pembroke Pines, Florida, United States
Status: Withdrawn
Atlanta, Georgia, United States
Status: Recruiting
Niles, Illinois, United States
Status: Recruiting
Topeka, Kansas, United States
Status: Recruiting
Westwood, Kansas, United States
Status: Recruiting
Baton Rouge, Louisiana, United States
Status: Withdrawn
Marrero, Louisiana, United States
Status: Recruiting
New Orleans, Louisiana, United States
Status: Withdrawn
Boston, Massachusetts, United States
Status: Not yet recruiting
Chicago, Michigan, United States
Status: Withdrawn
Lansing, Michigan, United States
Status: Recruiting
Rochester, Minnesota, United States
Status: Withdrawn
New York, New York, United States
Status: Withdrawn
New York, New York, United States
Status: Recruiting
Chapel Hill, North Carolina, United States
Status: Recruiting
Hickory, North Carolina, United States
Status: Withdrawn
Portland, Oregon, United States
Status: Recruiting
Philadelphia, Pennsylvania, United States
Status: Recruiting
Providence, Rhode Island, United States
Status: Recruiting
Greenville, South Carolina, United States
Status: Withdrawn
Houston, Texas, United States
Status: Withdrawn
Seattle, Washington, United States
Status: Recruiting
Madison, Wisconsin, United States
Status: Withdrawn
Milwaukee, Wisconsin, United States
Status: Withdrawn
Adelaide, Australia
Status: Recruiting
Concord, Australia
Status: Recruiting
Fitzroy, Australia
Status: Recruiting
Frankston, Australia
Status: Withdrawn
Heidelberg, Australia
Status: Withdrawn
Hobart, Australia
Status: Recruiting
Liverpool, Australia
Status: Withdrawn
Melbourne, Australia
Status: Recruiting
Nedlands, Australia
Status: Withdrawn
Nedlands, Australia
Status: Recruiting
Tweed Heads, Australia
Status: Withdrawn
Woodville South, Australia
Status: Recruiting
Barretos, Brazil
Status: Recruiting
Belo Horizonte, Brazil
Status: Withdrawn
Curitiba, Brazil
Status: Withdrawn
Florianopolis, Brazil
Status: Not yet recruiting
Fortaleza, Brazil
Status: Withdrawn
Porto Alegre, Brazil
Status: Recruiting
Rio De Janeiro, Brazil
Status: Not yet recruiting
Rio De Janeiro, Brazil
Status: Withdrawn
Salvador, Brazil
Status: Not yet recruiting
Sao Paulo, Brazil
Status: Recruiting
Sao Paulo, Brazil
Status: Not yet recruiting
Sao Paulo, Brazil
Status: Withdrawn
São José Do Rio Preto, Brazil
Status: Not yet recruiting
São Paulo, Brazil
Status: Withdrawn
Brno, Czech Republic
Status: Recruiting
Hradec Kralove, Czech Republic
Status: Recruiting
Olomouc, Czech Republic
Status: Withdrawn
Ostrava-Poruba, Czech Republic
Status: Recruiting
Praha 10, Czech Republic
Status: Recruiting
Praha 2, Czech Republic
Status: Recruiting
Bamberg, Germany
Status: Recruiting
Berlin, Germany
Status: Recruiting
Bremen, Germany
Status: Withdrawn
Duesseldorf, Germany
Status: Recruiting
Freiburg, Germany
Status: Recruiting
Gießen, Germany
Status: Withdrawn
Göttingen, Germany
Status: Recruiting
Hamburg, Germany
Status: Recruiting
Magdeburg, Germany
Status: Withdrawn
Mainz, Germany
Status: Recruiting
München, Germany
Status: Recruiting
Münster, Germany
Status: Withdrawn
Potsdam, Germany
Status: Withdrawn
Stuttgart, Germany
Status: Recruiting
Tübingen, Germany
Status: Recruiting
Ulm, Germany
Status: Recruiting
Würzburg, Germany
Status: Recruiting
Budapest, Hungary
Status: Recruiting
Debrecen, Hungary
Status: Recruiting
Győr, Hungary
Status: Completed
Pécs N/A, Hungary
Status: Recruiting
Veszprém, Hungary
Status: Completed
Busan, Korea, Republic of
Status: Recruiting
Jeonnam, Korea, Republic of
Status: Recruiting
Seoul, Korea, Republic of
Status: Recruiting
Seoul, Korea, Republic of
Status: Not yet recruiting
Suwon, Korea, Republic of
Status: Not yet recruiting
Ulsan, Korea, Republic of
Status: Recruiting
Ciudad De Mexico, Mexico
Status: Not yet recruiting
Huixquilucan, Mexico
Status: Not yet recruiting
Merida, Mexico
Status: Withdrawn
Mexico City, Mexico
Status: Not yet recruiting
Mexico, Mexico
Status: Not yet recruiting
Monterrey, Mexico
Status: Not yet recruiting
Puebla, Mexico
Status: Withdrawn
San Luis Potosi, Mexico
Status: Not yet recruiting
Alkmaar, Netherlands
Status: Recruiting
Amersfoort, Netherlands
Status: Recruiting
Amsterdam Zuidoost, Netherlands
Status: Withdrawn
Apeldoorn, Netherlands
Status: Withdrawn
Den Haag, Netherlands
Status: Recruiting
Den Haag, Netherlands
Status: Withdrawn
Dordrecht, Netherlands
Status: Recruiting
Groningen, Netherlands
Status: Recruiting
Hilversum, Netherlands
Status: Withdrawn
Hoofddorp, Netherlands
Status: Withdrawn
Leiden, Netherlands
Status: Recruiting
Maastricht, Netherlands
Status: Recruiting
Nijmegen, Netherlands
Status: Recruiting
Brzozów, Poland
Status: Withdrawn
Chorzów, Poland
Status: Recruiting
Katowice, Poland
Status: Recruiting
Krakow, Poland
Status: Recruiting
Poznan, Poland
Status: Withdrawn
Poznan, Poland
Status: Recruiting
Warszawa, Poland
Status: Recruiting
Warszawa, Poland
Status: Withdrawn
Dzerzhinsk, Russian Federation
Status: Withdrawn
Izhevsk, Russian Federation
Status: Withdrawn
Krasnodar, Russian Federation
Status: Recruiting
Moscow, Russian Federation
Status: Recruiting
Moscow, Russian Federation
Status: Withdrawn
Nizhny Novgorod, Russian Federation
Status: Recruiting
Penza, Russian Federation
Status: Recruiting
Petrozavodsk, Russian Federation
Status: Withdrawn
Pyatigorsk, Russian Federation
Status: Recruiting
Rostov-On-Don, Russian Federation
Status: Not yet recruiting
Ryazan, Russian Federation
Status: Recruiting
Saint Petersburg, Russian Federation
Status: Withdrawn
Samara, Russian Federation
Status: Recruiting
Sochi, Russian Federation
Status: Recruiting
St-Petersburg, Russian Federation
Status: Withdrawn
Syktyvkar, Russian Federation
Status: Recruiting
Madrid, Spain
Status: Recruiting
Salamanca, Spain
Status: Recruiting
San Sebastian De Los Reyes, Spain
Status: Recruiting
Toledo, Spain
Status: Recruiting
Valencia, Spain
Status: Recruiting
Göteborg, Sweden
Status: Withdrawn
Huddinge, Sweden
Status: Withdrawn
Linkoping, Sweden
Status: Recruiting
Lulea, Sweden
Status: Recruiting
Lund, Sweden
Status: Recruiting
Orebro, Sweden
Status: Recruiting
Stockholm, Sweden
Status: Withdrawn
Sundsvall, Sweden
Status: Recruiting
Umea, Sweden
Status: Recruiting
Uppsala, Sweden
Status: Recruiting
Västerås, Sweden
Status: Recruiting
Ankara, Turkey
Status: Recruiting
Istanbul, Turkey
Status: Recruiting
Izmir, Turkey
Status: Recruiting
Kayseri, Turkey
Status: Recruiting
Kocaeli, Turkey
Status: Recruiting
Malatya, Turkey
Status: Recruiting
Cherkassy, Ukraine
Status: Recruiting
Dnepropetrovsk, Ukraine
Status: Recruiting
Ivano-Frankivsk, Ukraine
Status: Recruiting
Khmelnitskiy, Ukraine
Status: Withdrawn
Kiev, Ukraine
Status: Recruiting
Lviv, Ukraine
Status: Recruiting
Poltava, Ukraine
Status: Recruiting
Ternopil, Ukraine
Status: Withdrawn
Vinnitsa, Ukraine
Status: Recruiting
Zaporizhzhya, Ukraine
Status: Recruiting
Zhytomyr, Ukraine
Status: Withdrawn
Start Date
August 2014
Completion Date
March 2017
Sponsors
Janssen Research & Development, LLC
Source
Janssen Research & Development, LLC
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page