NCT03841565

Daratumumab, Pomalidomide, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma

Phase II Trial of Daratumumab Retreatment in Patients With Relapsed Multiple Myeloma

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Academic and Community Cancer Research United · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well daratumumab, pomalidomide, and dexamethasone work in treating patients with multiple myeloma that has come back (relapsed). Immunotherapy with daratumumab may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as pomalidomide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving daratumumab with dexamethasone and pomalidomide may work bettering in treating patient compared to dexamethasone and pomalidomide alone.

Detailed description

PRIMARY OBJECTIVE: I. To determine the overall response rate (partial response \[PR\], very good partial response \[VGPR\], complete response \[CR\], or stringent complete response \[sCR\]) of daratumumab retreatment in combination with pomalidomide and dexamethasone (DPd) in patients with relapsed refractory multiple myeloma. SECONDARY OBJECTIVES: I. To assess progression free survival and overall survival associated with retreatment with daratumumab in combination with pomalidomide and dexamethasone (DPd) in patients with relapsed and refractory multiple myeloma. II. To determine the toxicities associated with retreatment with daratumumab in combination with pomalidomide and dexamethasone (DPd). OUTLINE: Patients receive pomalidomide orally (PO) once daily (QD) on days 1-21 and daratumumab intravenously (IV) on days 1, 8, 15, and 22 of cycles 1-2, days 1-15 of cycles 3-6, and day 1 of subsequent cycles. Patients also receive dexamethasone PO on days 1, 8, 15, and 22 of cycles 1-12. Cycles every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for every 3 months until subsequent treatment or progressive disease, then every 6 months for up to 3 years.

Conditions

• Recurrent Plasma Cell Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	Daratumumab	Given IV
DRUG	Dexamethasone	Given PO
DRUG	Pomalidomide	Given PO

Timeline

• Start date: 2020-08-07
• Primary completion: 2022-02-09
• Completion: 2022-02-09
• First posted: 2019-02-15
• Last updated: 2022-06-15

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study