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Immunomodulatory Agent

Velcade and Lenalidomide for Myelodysplastic Syndrome

Phase 1
Waitlist Available
Led By Andrew M Brunner, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A diagnosis of recurrent, persistent, or progressive acute myelogenous leukemia (AML), defined as >= 5% blasts in a patient with known prior history of AML, or recurrent, persistent, or progressive myelodysplastic syndrome (MDS) according to WHO criteria.
Must have undergone an allogeneic SCT (regardless of stem cell source)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This research study is evaluating drugs called bortezomib and lenalidomide as a possible treatment for myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). The purpose of this research study is to determine the safety and efficacy of the bortezomib and lenalidomide investigational combination. This drug combination has been used in the treatment of relapsed/refractory multiple myeloma and has been previously investigated in the treatment of MDS and AML, albeit at a lower dose of lenalidomide. In this research study, the investigators are looking for the highest dose of the combination that can be given safely and see how well it works as a combination for MDS and AML in individuals whose disease has relapsed after an SCT.

Eligible Conditions
  • Myelodysplastic Syndrome
  • Acute Myeloid Leukemia

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
MTD of Bortezomib and Lenalidomide
Secondary outcome measures
Assess clinical efficacy in terms of the number of patients experiencing a decrease in blast percentage.
Document the remission frequency in patients receiving up to 2 induction cycles of high-dose lenalidomide combined with Velcade.
Percentage of Complete Response
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Velcade and LenalidomideExperimental Treatment2 Interventions
Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. Each treatment cycle lasts 28 days (4 weeks). The first two cycles are called the induction cycles. If the participant respond to treatment during the first two cycles, they can continue on to the maintenance cycles. During the induction and maintenance cycles, patients receive up to the MTD of lenalidomide on days 1-21 days only. During days 22-28 (4th week) there is a rest period. Bortezomib: During the induction cycles, the medication will be given on days 2, 5, 9, and 12 followed by a 17-day rest period. During the maintenance cycles, bortezomib will be given on days 2, and 5 followed by 23-day rest period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
FDA approved
Bortezomib D-mannitol
FDA approved

Find a Location

Who is running the clinical trial?

Millennium Pharmaceuticals, Inc.Industry Sponsor
404 Previous Clinical Trials
46,927 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,918 Previous Clinical Trials
13,192,946 Total Patients Enrolled
Celgene CorporationIndustry Sponsor
444 Previous Clinical Trials
58,413 Total Patients Enrolled

Frequently Asked Questions

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~2 spots leftby Mar 2025