Study on Lenalidomide with or without Daratumumab/rHuPh20 as Maintenance Treatment After Stem Cell Transplant for Multiple Myeloma

Sponsor: SWOG Cancer Research Network

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04071457

Provider View

This clinical trial is exploring the use of Lenalidomide, with or without Daratumumab/rHuPh20, as a maintenance treatment for patients with multiple myeloma after they have undergone a stem cell transplant. The study aims to determine the best duration of therapy based on the presence of minimal residual disease (MRD).

Patient Parameters

Program Overview

The study involves patients who have had a stem cell transplant for multiple myeloma. Initially, patients are monitored until they start maintenance treatment. They are then randomly assigned to receive either Lenalidomide alone or Lenalidomide with Daratumumab/rHuPh20 for two years. After this period, the presence of minimal residual disease (MRD) is checked to guide further treatment. Patients with MRD will continue their assigned treatment, while those without MRD will be randomly assigned again to either continue or stop treatment. The study treatment can last up to seven years, with follow-up for up to 15 years.

Eligibility Criteria

Inclusion Criteria

  • Completed a stem cell transplant within the last 180 days.
  • Recent imaging tests like X-ray, CT scan, MRI, or PET scan for disease assessment.
  • Good overall health with a performance status of 2 or less.
  • Adequate bone marrow function with specific blood cell counts.
  • Proper liver function based on blood tests.
  • Sufficient kidney function as shown by creatinine clearance or serum creatinine levels.
  • Recovery from transplant-related side effects to a mild level, except for hair loss, fatigue, and missed periods.
  • Resolved mouth and digestive symptoms to a mild level.
  • Women who can become pregnant must have a negative pregnancy test before starting treatment and agree to use two forms of birth control.
  • Men must use condoms during sexual contact with women who can become pregnant.
  • Informed consent must be given by all participants.

Exclusion Criteria

  • No other maintenance therapy after stem cell transplant and before starting this study.
  • No disease progression between initial treatment and starting this study.

For the second randomization after 24 months of maintenance:

  • Completed 24 cycles of maintenance treatment with either Lenalidomide or Lenalidomide with Daratumumab/rHuPh20.
  • Must have a negative MRD test result after 24 months.
  • Must be in very good partial remission or better.

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