IRB #

STUDY00019993

Title

[NCI CIRB] - EAA173 - Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM)

Principal Investigator

Eva Medvedova

Study Purpose

The purpose of this study is to see whether or not the period of time that patients with high-risk smoldering multiple myeloma live from the time they start treatment by adding the drug daratumumab to the drug treatment regimen of lenalidomide and dexamethasone can be lengthen.

Medical Condition(s)

Smoldering Multiple Myeloma

Eligibility Criteria

1 - Diagnosis of Asymptomatic High-Risk Smoldering Multiple Myeloma within the past 12 months.

2 - Bone marrow biopsy and/or aspirate done within 28 days prior to randomization and must show 10-59% clonal plasma cells.

3 - Patients must have measurable disease

4 - Laboratory levels must be within parameters and obtained within 28 days prior to randomization.

5 - No prior or concurrent systemic or radiation therapy for treament of myeloma.

6 - No concurrent use of erythropoietin.

7 - Performance status of 0, 1, or 2.

8 - Patients with monoclonal gammopathy of undetermined significance are not eligible.

9 - Female patients must not be pregnant or nursing.

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

15 years from date of randomization.

Minors Included

No

Contact

Clinical Trials Information Line
Phone: 503-494-1080
Email: trials@ohsu.edu

Sponsor

ECOG-ACRIN

Recruitment End

05/31/2024

Compensation Provided

No


Go Back