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Phase III Study of Daratumumab/rHuPH20 (NSC- 810307) + Lenalidomide or Lenalidomide as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC)

Clinical Trial Details

The usual approach for myeloma patients who are not in a study is treatment with lenalidomide alone after stem cell transplant.

This study is being done to answer the following questions: 

  1. Will adding the drug daratumumab/rHuPH20 to the usual maintenance treatment with lenalidomide after stem cell transplant help myeloma patients survive longer?
  2. For patients who have no evidence of myeloma in their bone marrow (patients who do not have “minimum residual disease” [MRD-negative]), should maintenance therapy be stopped after 2 years? 

Patients in this study will either get lenalidomide alone after stem cell transplant or will get lenalidomide and daratumumab/rHuPH20. Both groups will get tested to see whether they have MRD (small amounts of multiple myeloma cells left after cancer is in remission). If they have MRD and their disease is responding to treatment, they will get treatment until their disease gets worse or their side effects are too great. If they do not have MRD and their disease is responding to treatment, they will be randomized to either STOP treatment or CONTINUE treatment until their disease gets worse or their side effects are too great.

This MRD test is approved by the FDA to test for low amounts of disease in myeloma patients. It is not FDA-approved for doctors to use to decide whether to stop maintenance therapy. One of the questions this study is asking is whether this test can be used to make that treatment decision.

Key Eligibility: 
  • Adults between 18-75 years of age with confirmed diagnosis of symptomatic multiple myeloma
  • No smoldering myeloma or plasma cell leukemia
  • Zubrod Performance Status ≤ 2
  • No organ involvement by amyloidosis 
  • Initiated induction therapy within 12 months and received at least two cycles of induction therapy
  • Willing and able to take aspirin, low molecular weight heparin, warfarin, or equivalent oral anticoagulation
  • Adequate renal, hepatic, and bone marrow function
  • No COPD
  • No moderate or severe asthma
  • No prior autograft or allograft

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

June Greenberg, RN
(212) 746-2651
jdg2002@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1907020421

ClinicalTrials.gov:

NCT04071457

Sponsor:

S1803 / BMT CTN 1706

Status

Open to Enrollment

Age Group

Adult

Sponsor