Study on Quality of Life in People with Multiple Myeloma Receiving Daratumumab or Lenalidomide

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04497961

Provider View

This study is comparing two maintenance treatments for people with multiple myeloma who have responded well to initial therapy. Researchers want to see if daratumumab or lenalidomide provides a better quality of life during treatment.

Patient Parameters

Program Overview

The study aims to compare two maintenance therapy options for people with newly diagnosed multiple myeloma (MM) who have responded well to their first treatment. Researchers will look at the usual maintenance therapy, lenalidomide, and compare it to daratumumab to see which one offers a better quality of life. Participants will complete various questionnaires to measure their quality of life. This research will help determine if daratumumab is a better, similar, or worse option compared to the usual approach.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with plasma cell myeloma and responded well to initial treatment.
  • Enrolled within 6 months of completing initial therapy, or 7 months if delayed due to medical or logistical reasons.
  • Age 18 or older.
  • Good overall health with an ECOG performance status of 0 to 2.
  • If had a stem cell transplant, must wait at least 100 days before joining the study.
  • Adequate blood, kidney, and liver function.
  • Able to take daily blood-thinning medication and antiviral medication.
  • Must understand and sign a consent form.

Additional criteria for those in Arm A (lenalidomide):

  • Must join the Revlimid REMS® program and follow its requirements.
  • Women of childbearing age must avoid pregnancy and use effective birth control during and after the study.
  • Men must use condoms during sexual contact with women of childbearing age.

Additional criteria for those in Arm B (daratumumab):

  • Women and men must use effective birth control during treatment and for 3 months after.
  • Agree not to donate eggs or sperm for 3 months after treatment.

Additional criteria for those interested in the nutrition sub-study:

  • Interested in trying a plant-based diet.

Exclusion Criteria

  • Have progressive or treatment-resistant multiple myeloma.
  • History of not responding to lenalidomide or daratumumab.
  • Previously treated for smoldering myeloma.
  • Currently receiving other investigational treatments for myeloma.
  • Have plasma cell leukemia.
  • Pregnant or breastfeeding women.
  • Have severe lung disease or uncontrolled asthma.
  • Uncontrolled high blood pressure or diabetes.
  • Positive for hepatitis B or C, unless treated and cleared.
  • Diagnosed with another cancer within the last 3 years, except for certain skin cancers.
  • Uncontrolled HIV infection.
  • Previous organ transplant requiring immune suppression.
  • Recent heart problems or severe heart disease.
  • Conditions affecting drug absorption.
  • Uncontrolled illness or psychiatric conditions.
  • Severe nerve damage.
  • Recent major surgery.
  • Severe reactions to thalidomide or lenalidomide.
  • Language barriers for study questionnaires.

Additional exclusion for nutrition sub-study:

  • Allergy to legumes or severe nut allergies.

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