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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

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 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

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
Autologous Stem Cell Transplant
2016
Completed Phase 2
~360
Bortezomib
2005
Completed Phase 3
~1410
Lenalidomide
2005
Completed Phase 3
~1340
Dexamethasone
2007
Completed Phase 4
~2640

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,100 Previous Clinical Trials
353,051 Total Patients Enrolled
52 Trials studying Multiple Myeloma
43,579 Patients Enrolled for Multiple Myeloma
Millennium Pharmaceuticals, Inc.Industry Sponsor
404 Previous Clinical Trials
46,868 Total Patients Enrolled
82 Trials studying Multiple Myeloma
10,016 Patients Enrolled for Multiple Myeloma
CelgeneIndustry Sponsor
645 Previous Clinical Trials
130,503 Total Patients Enrolled
145 Trials studying Multiple Myeloma
41,757 Patients Enrolled for Multiple Myeloma
~5 spots leftby Sep 2025
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