IRB #

STUDY00020230

Title

[NCI CIRB] S1803: 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 STUDY)

Principal Investigator

Sarah Nagle

Study Purpose

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?

Medical Condition(s)

multiple myeloma
autologous stem-cell transplant (ASCT)

Eligibility Criteria

- Participant must be between 18 and 75 years old
- Participants must have had or will have an autologous stem cell transplant (ASCT)

Age Range

18 - 75

Healthy Volunteers Needed

No

Duration of Participation

Participants will be on study for up to 15 years from the time of study entry through follow up.

Minors Included

No

Contact

Knight Information Line - trials@ohsu.edu or 503-494-1080

Sponsor

SWOG

Recruitment End

07/01/2024

Compensation Provided

No


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