Lenalidomide Maintenance Therapy for Plasma Cell Myeloma
Sponsor: Memorial Sloan Kettering Cancer Center
Sponsor score: 60
ClinicalTrials ID:NCT02538198
This Phase 2 study is exploring the effects of maintenance therapy with lenalidomide in patients who have been treated for plasma cell myeloma and currently show no signs of the cancer.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to understand the benefits and side effects of using lenalidomide as a maintenance therapy in patients who have been treated for plasma cell myeloma and are currently in remission, meaning they show no signs of the cancer.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 and older who have been treated for plasma cell myeloma and show stable disease or better.
- Must have good overall health, with specific blood counts and organ functions within acceptable ranges.
- Must be registered in the Revlimid REMS® program and agree to follow its requirements.
- Women of childbearing potential must have a negative pregnancy test and agree to use two forms of birth control.
- Men must agree to use a condom during sexual activity with women who can become pregnant.
- Must be able to take daily blood-thinning medication like aspirin.
- Must understand and agree to sign a consent form to participate.
Exclusion Criteria
- Patients whose myeloma is worsening or not responding to treatment.
- Patients who have not responded to lenalidomide in their most recent treatment.
- Patients taking other experimental treatments for myeloma.
- Women who are pregnant or breastfeeding.
- Patients with uncontrolled high blood pressure or diabetes.
- Patients with active hepatitis B or C infections.
- Patients with another cancer diagnosis within the last 3 years, except for certain skin cancers.
- Patients with HIV or those on treatment for HIV/AIDS.
- Patients who have had an organ transplant or stem cell transplant.
- Patients with recent heart problems or severe heart conditions.
- Patients with conditions that prevent them from absorbing the study drug.
- Patients with severe nerve damage or who cannot take blood-thinning medication.
- Patients who have had major surgery within the last month.
- Patients who have had severe reactions to thalidomide or lenalidomide in the past.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | Basking Ridge | New Jersey | |
| Memorial Sloan Kettering Bergen | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Cancer Center @ Suffolk | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| Memorial Sloan Kettering Nassau | 11553 | Uniondale | New York |
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