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

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

FACILITYZIPCITYSTATE
Memorial Sloan Kettering Cancer CenterBasking RidgeNew Jersey
Memorial Sloan Kettering Bergen07645MontvaleNew Jersey
Memorial Sloan Kettering Cancer Center @ Suffolk11725CommackNew York
Memorial Sloan Kettering Westchester10604HarrisonNew York
Memorial Sloan Kettering Cancer Center10065New YorkNew York
Memorial Sloan Kettering Nassau11553UniondaleNew York

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