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Proteasome Inhibitor

Bortezomib + Lenalidomide + Dexamethasone for Multiple Myeloma

Phase 2

Waitlist Available

Led By Jacob Laubach

Research Sponsored by Dana-Farber Cancer Institute

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 survival was assessed up to 1 year.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a possible new treatment for multiple myeloma that combines three drugs.

Who is the study for?

This trial is for adults with newly diagnosed multiple myeloma who haven't had systemic therapy yet. They must have certain levels of monoclonal protein, organ dysfunction related to myeloma, and be able to follow the study plan. Women must test negative for pregnancy and use birth control; men should also use contraception if with a female partner of childbearing potential.

What is being tested?

The trial tests a drug combo: lenalidomide, subcutaneous bortezomib, and dexamethasone (RVD) as initial treatment for multiple myeloma. It includes those eligible after screening based on specific health criteria like kidney function and blood cell counts.

What are the potential side effects?

Possible side effects include reactions at the injection site from bortezomib, increased risk of infections due to lowered immunity from lenalidomide, and high blood sugar or mood changes from dexamethasone. Each patient's experience may vary.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ survival was assessed up to 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~survival was assessed up to 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and survival was assessed up to 1 year. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

4-Cycle Induction Overall Response Rate (ORR)

Four-cycle Induction Peripheral Neuropathy (PN) Rate

Grade 3-4 Induction Peripheral Neuropathy Rate

+1 more

Secondary study objectives

1-Year Progression Free Survival (PFS) Probability

1-year Overall Survival (OS) Rate

Median Duration of Response (DOR)

+1 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: Lenalidomide, subcutaneous Bortezomib, DexamethasoneExperimental Treatment5 Interventions

Lenalidomide (R): 25 mg on days 1-14 orally Subcutaneous Bortezomib (sqV): 1.3 mg/m\^2 on days 1, 4, 8 and 11 Dexamethasone (d): 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 Stem cell mobilization occurs at the end of Cycle 4. Participants may elect to stop treatment at the end of Induction Cycle 4 and proceed to autologous stem cell transplant (ASCT) with melphalan 200 mg/m\^2 conditioning, or receive a full 8 cycles of RsqVd induction therapy. RsqVd cycle duration is 21-days. Maintenance follows with the specific regimen determined by risk category. High-risk participants defined as those with International Staging System (ISS) stage II or stage III disease and/or high-risk cytogenetics including t(4;14), t(4; 16), del(17p) receive sqV of 1.3 mg/m\^2 on days 1 and 15 in addition to R 10mg (15mg after cycle 3 if tolerated) on days 1-21 of 28-day cycle. Standard-risk participants receive R monotherapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stem Cell Mobilization

2015

Completed Phase 2

~40

Autologous Stem Cell Transplant

2016

Completed Phase 2

~360