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”
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.
Relapsed and refractory multiple myeloma (RRMM)
- 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.
18 - 99
Healthy Volunteers Needed
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.
Clinical Trials Information Line
Celgene International II Sàrl