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.

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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.

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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

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

499

Study ID:

NCT02136134

Recruitment Status:

Active, not recruiting

Sponsor:

Janssen Research & Development, LLC

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There is 1 Location for this study

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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

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Concord , , Australia

Fitzroy , , Australia

Hobart , , Australia

Melbourne , , Australia

Nedlands , , Australia

Woodville South , , Australia

Barretos , , Brazil

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Salvador , , Brazil

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São Paulo , , Brazil

Brno , , Czechia

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Praha 10 , , Czechia

Praha 2 , , Czechia

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München , , Germany

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Ulm , , Germany

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Budapest , , Hungary

Debrecen , , Hungary

Győr , , Hungary

Pécs N/a , , 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

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

499

Study ID:

NCT02136134

Recruitment Status:

Active, not recruiting

Sponsor:


Janssen Research & Development, LLC

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