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Immunomodulatory Agent

Velcade and Lenalidomide for Myelodysplastic Syndrome

Q: What are the potential risks associated with Velcade and Lenalidomide when used in patient care?

<p>The safety rating for <a href="https://www.withpower.com/clinical-trials/velcade">Velcade</a> and <a href="https://www.withpower.com/clinical-trials/lenalidomide">Lenalidomide</a>, as estimated by our team at Power on a scale of 1 to 3, is set at 1. This corresponds to the early Phase 1 trial stage with restricted data backing both efficacy and safety profiles.</p>

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

Study 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.Check my eligibility

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.See study design

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

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Millennium Pharmaceuticals, Inc.Industry Sponsor

404 Previous Clinical Trials

46,892 Total Patients Enrolled

Massachusetts General HospitalLead Sponsor

2,937 Previous Clinical Trials

13,199,028 Total Patients Enrolled

Celgene CorporationIndustry Sponsor

444 Previous Clinical Trials

58,214 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new patients currently being enrolled in this ongoing clinical trial?

"As per clinicaltrials.gov records, this particular research endeavor is no longer in need of volunteers. Originally listed on February 1st, 2015 and last updated on March 12th, 2024, the trial has concluded patient recruitment. Nevertheless, it's worth noting that there are currently 3014 other trials open for enrollment."

Answered by AI

Is this a new type of medical investigation?

"Since 2006, Velcade and Lenalidomide have been subjects of investigation. The initial clinical trial in that year was funded by Millennium Pharmaceuticals, Inc., engaging a cohort of 151 participants. Subsequently, this drug combination advanced to Phase 2 status. Presently, there are ongoing investigations into Velcade and Lenalidomide spanning across 93 active studies conducted in 748 urban areas within 47 nations globally."

Answered by AI

What is the current number of individuals actively participating in this clinical research?

"Patient recruitment for this trial has ceased. The study was initially listed on 2/1/2015 and most recently updated on 3/12/2024. For those interested in other research opportunities, there are currently 2921 ongoing studies seeking participants with myelodysplastic syndrome, along with an additional 93 trials focusing on Velcade and Lenalidomide actively enrolling subjects."

Answered by AI

For which medical conditions are Velcade and Lenalidomide frequently prescribed?

"The main indication for Velcade and Lenalidomide is the treatment of multiple myeloma. Additionally, these medications are prescribed for various other conditions such as relapsed or refractory lymphoma, chronic lymphocytic leukemia that has been previously treated."

Answered by AI

What are the potential risks associated with Velcade and Lenalidomide when used in patient care?

"The safety rating for Velcade and Lenalidomide, as estimated by our team at Power on a scale of 1 to 3, is set at 1. This corresponds to the early Phase 1 trial stage with restricted data backing both efficacy and safety profiles."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Velcade and Lenalidomide in Patients With Relapsed AML and MDS After Allogeneic Stem Cell Transplantation

Andrew Mark Brunner, MD 2015. "Velcade and Lenalidomide in Patients With Relapsed AML and MDS After Allogeneic Stem Cell Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02312102.

All > Stem Cell Transplant > Revlimid