IRB #

STUDY00016905

Title

Multicenter, Single-arm, Phase 2 Study to Determine the Efficacy for the Combination of Daratumumab (DARA) plus Durvalumab (DURVA) (D2) in Subjects with Relapsed and Refractory Multiple Myeloma (RRMM) Who Have Progressed on DARA while on a DARA- containing Regimen as the Most Recent Multiple Myeloma Therapy. “Fusion MM-005”

Principal Investigator

Emma Scott

Study Purpose

The main purpose of this study is to determine how effective the combination of daratumumab (DARA) plus durvalumab (DURVA) is in patients with relapsed and refractory (RRMM) who have had disease progression on DARA while on a DARA-containing regimen as their most recent myeloma treatment. Information regarding how safe the combination of DARA plus DURVA treatment is and the pharmacokinetics (how the body absorbs, distributes, breaks down and eliminates drugs) of this drug combination will be studied.

Medical Condition(s)

Relapsed and refractory multiple myeloma (RRMM)

Eligibility Criteria

- You must have received at least 3 prior anti-myeloma regimens including a proteasome inhibitor (PI, such as bortezomib or carfilzomib) and an immunomodulatory agent (IMiD, such as pomalidomide or lenalidomide) or you must be double-refractory to a PI and an IMiD.
- You must have had disease progression on daratumumab (DARA) either as a single agent or in combination on your last MM therapy.

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

Should you benefit from the treatment and the investigator regards the study treatment to remain beneficial, you can continue study treatment. The maximum time you will be in the study will depend on your response to the treatment. After you are done with the study treatment, you will need to come back for follow-up visits after 28 days and 90 days.

Minors Included

No

Contact

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

Sponsor

Celgene International II Sàrl

Recruitment End

01/01/2020

Compensation Provided

No


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