Multiple Myeloma Clinical Trial
Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma
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.
Full 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.
Eligibility 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
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There is 1 Location for this study
Birmingham Alabama, , United States
Los Angeles California, , United States
Stamford Connecticut, , United States
Jacksonville Florida, , United States
Atlanta Georgia, , United States
Niles Illinois, , United States
Topeka Kansas, , United States
Westwood Kansas, , United States
Marrero Louisiana, , United States
Boston Massachusetts, , United States
Lansing Michigan, , United States
New York New York, , United States
Chapel Hill North Carolina, , United States
Portland Oregon, , United States
Philadelphia Pennsylvania, , United States
Providence Rhode Island, , United States
Seattle Washington, , United States
Adelaide , , Australia
Concord , , Australia
Fitzroy , , Australia
Hobart , , Australia
Melbourne , , Australia
Nedlands , , Australia
Woodville South , , Australia
Barretos , , Brazil
Porto Alegre , , Brazil
Salvador , , Brazil
Sao Paulo , , Brazil
São Paulo , , Brazil
Brno , , Czechia
Hradec Kralove , , Czechia
Ostrava-Poruba , , Czechia
Praha 10 , , Czechia
Praha 2 , , Czechia
Bamberg , , Germany
Berlin , , Germany
Duesseldorf , , Germany
Freiburg , , Germany
Göttingen , , Germany
Hamburg , , Germany
Mainz , , Germany
München , , Germany
Stuttgart , , Germany
Tübingen , , Germany
Ulm , , Germany
Würzburg , , Germany
Budapest , , Hungary
Debrecen , , Hungary
Győr , , Hungary
Pecs , , Hungary
Veszprém , , Hungary
Busan , , Korea, Republic of
Hwasun , , Korea, Republic of
Seoul , , Korea, Republic of
Suwon , , Korea, Republic of
Ulsan , , Korea, Republic of
Huixquilucan , , Mexico
Monterrey , , Mexico
Alkmaar , , Netherlands
Amersfoort , , Netherlands
Den Haag , , Netherlands
Dordrecht , , Netherlands
Groningen , , Netherlands
Leiden , , Netherlands
Maastricht , , Netherlands
Nijmegen , , Netherlands
Chorzów , , Poland
Katowice , , Poland
Krakow , , Poland
Poznan , , Poland
Warszawa , , Poland
Krasnodar , , Russian Federation
Moscow , , Russian Federation
Nizhny Novgorod , , Russian Federation
Penza , , Russian Federation
Pyatigorsk , , Russian Federation
Ryazan , , Russian Federation
Samara , , Russian Federation
Sochi , , Russian Federation
Syktyvkar , , Russian Federation
Madrid , , Spain
Salamanca , , Spain
San Sebastian de los Reyes , , Spain
Toledo , , Spain
Valencia , , Spain
Linkoping , , Sweden
Lulea , , Sweden
Lund , , Sweden
Orebro , , Sweden
Sundsvall , , Sweden
Umea , , Sweden
Uppsala , , Sweden
Västerås , , Sweden
Ankara , , Turkey
Istanbul , , Turkey
Izmir , , Turkey
Kayseri , , Turkey
Kocaeli , , Turkey
Malatya , , Turkey
Cherkasy , , Ukraine
Dnepropetrovsk , , Ukraine
Ivano-Frankivsk , , Ukraine
Kiev , , Ukraine
Lviv , , Ukraine
Poltava , , Ukraine
Vinnitsa , , Ukraine
Zaporizhzhya , , Ukraine
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