NCT03590652

Daratumumab, Ixazomib, Pomalidomide, and Dexamethasone as Salvage Therapy in Relapsed/Refractory Multiple Myeloma

Phase II Study of the Combination of Daratumumab, Ixazomib, Pomalidomide, and Dexamethasone as Salvage Therapy in Relapsed/Refractory Multiple Myeloma A University of California Hematologic Malignancies Consortium Protocol (UCHMC1809)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the overall response rate of patients with Multiple Myeloma to the combination of Daratumumab, Ixazomib, Pomalidomide and Dexamethasone.

Detailed description

The purpose of this study is to determine the overall response rate of patients with Multiple Myeloma to the combination of Daratumumab, Ixazomib, Pomalidomide and Dexamethasone. The drugs being used in this study are daratumumab ixazomib, pomalidomide, and dexamethasone. Ixazomib may stop the growth of cancer by interfering with proteasomes (the protein breakdown mechanism in the cells). Pomalidomide, and dexamethasone are standard drugs that can change and regulate the immune system and may stop cancer cells from growing. Both Ixazomib and Daratumumab are approved for use in Multiple Myeloma, but not in this combination.

Conditions

• Relapsed/Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Ixazomib	4mg PO days 1,8,15 on 28-day cycle
DRUG	Pomalidomide	4mg days PO 1-21/28 days
DRUG	Dexamethasone	40mg\*\* PO weekly \*\* starting dose for age \>75 may be 20mg
DRUG	Daratumumab-Hyaluronidase-Fihj@1,800 Mg-30,000 Unit/15 mL@SUBCUT@VIAL (ML)	1800mg SQ weekly x 8 weeks, biweekly x 8 doses, then monthly

Timeline

• Start date: 2018-10-17
• Primary completion: 2025-07-02
• Completion: 2025-07-02
• First posted: 2018-07-18
• Last updated: 2025-10-21

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study