A Study of Health-Related Quality of Life in People With Multiple Myeloma Receiving Daratumumab or Lenalidomide


Full Title

Daratumumab Versus Lenalidomide Maintenance Therapy for Multiple Myeloma: A Randomized Pilot Study Comparing Patient-Reported Health Related Quality of Life Measures with a Plant Based Nutrition Intervention Sub Study (NUTRIVENTION-4)


Lenalidomide is a drug typically used as maintenance therapy in people with multiple myeloma who have responded well to their first round of treatment. Daratumumab is used to treat multiple myeloma when given in combination with other drugs; its use alone is considered investigational.

In this study, researchers are comparing lenalidomide and daratumumab for maintenance therapy in people with multiple myeloma to see if one is better than the other, how they affect patients’ quality of life, and to see if one is easier to take than the other. Patients will be randomly assigned to receive one drug or the other after initial therapy is complete. Lenalidomide is taken orally (by mouth) and daratumumab is given as a subcutaneous (under the skin) injection.

Patients in each study group will also be able to participate in the NUTRIVENTION-4 substudy. The first 15 patients from each group who are interested will be enrolled. They will eat plant-based meals (shipped to their homes) and receive nutrition counseling for 12 weeks, followed by additional 12 weeks of counseling alone. They will continue taking their lenalidomide or daratumumab as maintenance therapy.

Who Can Join

To be eligible for this study, patients must meet several criteria, including:

  • Patients must have completed and responded well to their initial treatment for multiple myeloma.
  • Patients should recover from the serious side effects of previous treatments.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.


For more information about this study and to inquire about eligibility, please contact Dr. Urvi Shah at 646-608-3713




Phase II (phase 2)



ClinicalTrials.gov ID