Study on Lenalidomide and Melphalan for Stem Cell Transplant in Relapsed Multiple Myeloma
Sponsor: Weill Medical College of Cornell University
ClinicalTrials ID:NCT01054196
This clinical trial is testing a combination of lenalidomide and melphalan before stem cell transplantation to see if it can improve treatment outcomes for patients with relapsed multiple myeloma.
Patient Parameters
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Program Overview
The study is divided into two phases. Phase 1 aims to find the highest safe dose of lenalidomide that can be combined with melphalan before a stem cell transplant. Phase 2 will test if this combination, followed by maintenance lenalidomide, improves the response and duration of response in patients with relapsed multiple myeloma.
Description
In Phase 1, participants will receive increasing doses of lenalidomide to find the maximum dose that can be safely given with melphalan before a stem cell transplant. The doses will start at 25mg daily and increase through several levels.
In Phase 2, the safe dose found in Phase 1 will be used. Participants will take lenalidomide for 5 days before receiving melphalan for 2 days. After a short wait, they will receive their own stem cells back to help restore their bone marrow. Later, they will start maintenance lenalidomide to help keep the cancer under control.
Participants will need to meet certain health criteria and agree to follow specific safety measures, including using birth control if they are of childbearing potential. The study will also require regular health checks and follow-up visits to monitor the treatment's effects.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with relapsed or refractory multiple myeloma.
- Have measurable disease based on specific medical criteria.
- Have received at least one prior treatment for multiple myeloma.
- Be 18 years or older.
- Have a life expectancy of more than 12 weeks.
- Be in good overall health with a performance status of 0 to 2.
- Be registered in the RevAssist program and comply with its requirements.
- Have normal organ and bone marrow function based on specific blood tests.
- Have enough stem cells collected for transplantation.
- Women of childbearing potential must use effective birth control and undergo regular pregnancy tests.
- Men must use condoms during sexual activity.
- Be willing to take blood thinners and low-dose aspirin as part of the treatment.
- Understand and agree to sign a consent form.
Exclusion Criteria
- Have received myeloma treatment within 14 days before the study.
- Be taking other investigational drugs.
- Have allergies to lenalidomide or melphalan.
- Have HIV or hepatitis B or C.
- Have uncontrolled illnesses or conditions that would interfere with the study.
- Be pregnant or breastfeeding.
- Have had a blood clot or similar event within 60 days before the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Weill Cornell Medical College | 10065 | New York | New York |
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