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Proteasome Inhibitor

Dara-RVd for Multiple Myeloma

Phase 2

Waitlist Available

Led By Samuel M Rubinstein, MD, MSCI

Research Sponsored by UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effects of a new treatment schedule using a combination of drugs for patients with newly diagnosed multiple myeloma who are eligible for stem cell transplantation. The current standard treatment involves a regimen

Who is the study for?

This trial is for adults over 18 with newly diagnosed multiple myeloma who are fit enough for a stem cell transplant. Participants must be able to follow the study's procedures and not have any serious infections or be pregnant/breastfeeding.

What is being tested?

The trial tests a less frequent dosing schedule of Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone (Dara-RVd) in patients eligible for autologous stem cell transplantation. It aims to see if taking Bortezomib once weekly instead of twice reduces side effects while remaining effective.

What are the potential side effects?

Possible side effects include reactions at the infusion site, blood disorders like low platelets or anemia, nerve damage causing numbness or pain in hands and feet (peripheral neuropathy), fatigue, digestive issues such as constipation or diarrhea, and increased risk of infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The rate of achievement of bone marrow minimal residual disease (MRD) negativity

Secondary study objectives

Maximum depth of response (from PR to CR, including sCR)

Overall Survival (OS)

Overall response rate (ORR)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Daratumumab, lenalidomide, bortezomib, and dexamethasoneExperimental Treatment4 Interventions

Subjects with newly diagnosed multiple myeloma (NDMM) are eligible for standard-of-care autologous stem cell transplantation (ASCT) and receive daratumumab, lenalidomide, bortezomib, and dexamethasone (Dara-RVd).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2650

Daratumumab

2014

Completed Phase 3

~2000