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Proteasome Inhibitor

Daratumumab + Bortezomib + Dexamethasone for Multiple Myeloma

Phase 3

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have had documented multiple myeloma

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years 9 months

Awards & highlights

Study Summary

This trial will test if adding daratumumab to the standard treatment for MM can help people with MM that has relapsed or is refractory.

Who is the study for?

This trial is for people with multiple myeloma that has come back or didn't respond to treatment. They should have had some success with previous treatments, be reasonably fit (ECOG score 0-2), and not have used Daratumumab or similar drugs before. They can't join if they're resistant to Bortezomib, intolerant to it, recently received other myeloma treatments, have another cancer in the last 3 years, or a condition that could affect the study.Check my eligibility

What is being tested?

The study tests adding Daratumumab to an existing two-drug combo of Bortezomib and Dexamethasone in those whose multiple myeloma has returned or hasn’t improved after treatment. It compares this three-drug regimen against the standard two-drug therapy to see which works better.See study design

What are the potential side effects?

Possible side effects include reactions at the injection site, increased risk of infections due to immune system effects, fatigue from low blood counts, nerve damage symptoms like numbness or pain from Bortezomib use, and steroid-related issues such as mood swings or elevated blood sugar.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with multiple myeloma.

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I am able to care for myself and perform daily activities.

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I have previously responded well to at least one cancer treatment.

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I have been treated for multiple myeloma before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 years 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free Survival (PFS)

Secondary outcome measures

Overall Response Rate (ORR)

Overall Survival (OS)

Percentage of Participants With Negative Minimal Residual Disease (MRD)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Daratumumab+VELCADE+dexamethasoneExperimental Treatment3 Interventions

Daratumumab, VELCADE and dexamethasone

Group II: VELCADE+dexamethasoneActive Control2 Interventions

VELCADE and dexamethasone.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2590

VELCADE (Bortezomib)

2014

Completed Phase 3

~500

Daratumumab

2014

Completed Phase 3

~1860

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,383,810 Total Patients Enrolled

70 Trials studying Multiple Myeloma

18,919 Patients Enrolled for Multiple Myeloma

Janssen Research & Development, LLC Clinical trialStudy DirectorJanssen Research & Development, LLC

9 Previous Clinical Trials

1,801 Total Patients Enrolled

Media Library

Bortezomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02136134 — Phase 3

Multiple Myeloma Research Study Groups: VELCADE+dexamethasone, Daratumumab+VELCADE+dexamethasone

Multiple Myeloma Clinical Trial 2023: Bortezomib Highlights & Side Effects. Trial Name: NCT02136134 — Phase 3

Bortezomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02136134 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does Dexamethasone have any harmful side effects?

"Dexamethasone has been tested in multiple Phase 3 trials, providing evidence for its efficacy and safety."

Answered by AI

What medical conditions does Dexamethasone typically alleviate?

"Dexamethasone is often given to patients to help with ophthalmia, sympathetic. Additionally, it has shown to be an effective way to treat branch retinal vein occlusion, macular edema, and communicable diseases."

Answered by AI

Are researchers currently looking for participants for this trial?

"This clinical trial is not presently searching for candidates at this time. The trial was originally posted on 2014-08-15 and was most recently edited on 2022-11-03. If you are exploring for other studies, there are presently 826 studies actively admitting participants with multiple myeloma and 675 trials for Dexamethasone actively recruiting patients."

Answered by AI

What are the most recent findings from other researchers about Dexamethasone?

"First appearing in clinical trials in 2002, dexamethasone has been studied for almost two decades with over 1400 completed trials. Currently, there are 675 active studies being conducted, with a significant portion taking place in Boston, Massachusetts."

Answered by AI

Are there any other places in town where I could participate in this clinical trial?

"Right now, this trial is operational in 17 different hospitals. Some of these locations include Boston, Lansing, and New york. There are also 17 other places where this trial is running. If you enroll in the trial, you should choose the location that is closest to you to limit travel as much as possible."

Answered by AI

How many total subjects are enrolled in this clinical trial?

"As of November 3rd, 2022, this study is no longer enrolling patients. The original posting date for the trial was August 15th, 2014. There are 826 other clinical trials for multiple myeloma and 675 trials for Dexamethasone that are currently looking for participants."

Answered by AI

Recent research and studies

Journal of Hematology & OncologyJournal

Daratumumab, Bortezomib, and Dexamethasone in Relapsed or Refractory Multiple Myeloma: Subgroup Analysis of CASTOR Based on Cytogenetic Risk

Weisel, Katja, Andrew Spencer, Suzanne Lentzsch, Hervé Avet-Loiseau, Tomer M. Mark, Ivan Spicka, Tamas Masszi, et al.. 2020. “Daratumumab, Bortezomib, and Dexamethasone in Relapsed or Refractory Multiple Myeloma: Subgroup Analysis of CASTOR Based on Cytogenetic Risk”. Journal of Hematology & Oncology. Springer Science and Business Media LLC. doi:10.1186/s13045-020-00948-5.

HaematologicaJournal

Daratumumab-based Regimens Are Highly Effective and Well Tolerated in Relapsed or Refractory Multiple Myeloma Regardless of Patient Age: Subgroup Analysis of the Phase 3 CASTOR and POLLUX Studies

Mateos, Maria-Victoria, Andrew Spencer, Ajay K. Nooka, Ludek Pour, Katja Weisel, Michele Cavo, Jacob P. Laubach, et al.. 2019. “Daratumumab-based Regimens Are Highly Effective and Well Tolerated in Relapsed or Refractory Multiple Myeloma Regardless of Patient Age: Subgroup Analysis of the Phase 3 CASTOR and POLLUX Studies”. Haematologica. Ferrata Storti Foundation (Haematologica). doi:10.3324/haematol.2019.217448.

New England Journal of MedicineJournal

Daratumumab, Bortezomib, and Dexamethasone for Multiple Myeloma

Palumbo, Antonio, Asher Chanan-Khan, Katja Weisel, Ajay K. Nooka, Tamas Masszi, Meral Beksac, Ivan Spicka, et al.. 2016. “Daratumumab, Bortezomib, and Dexamethasone for Multiple Myeloma”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1606038.

Journal of Clinical OncologyJournal