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Immunomodulatory Agent

Velcade + 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Approved for 10 Other Conditions

All Individual Drugs Already Approved

Summary

"This trial is testing a combination of drugs, bortezomib and lenalidomide, to see if they can be a safe and effective treatment for myelodysplastic syndrome

Who is the study for?

This trial is for adults over 18 with relapsed Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) after an allogeneic stem cell transplant. Participants must have a certain level of physical fitness, be off most immunosuppressive drugs, and have specific organ function levels within normal ranges.

What is being tested?

The study tests the safety and effectiveness of combining two drugs, bortezomib (Velcade) and lenalidomide, at higher doses than previously used in MDS and AML patients who've had their disease return post-transplant. The goal is to find the highest safe dose that works well together.

What are the potential side effects?

Potential side effects from Velcade and Lenalidomide may include fatigue, digestive issues like nausea or diarrhea, blood count changes leading to increased infection risk or bleeding problems, nerve damage causing numbness or pain, as well as potential liver abnormalities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

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

Primary study objectives

MTD of Bortezomib and Lenalidomide

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

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

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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

Bortezomib D-mannitol

FDA approved

Lenalidomide

FDA approved

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