NCT04302324

A Phase II Study of Daratumumab, Clarithromycin, Pomalidomide And Dexamethasone (D-ClaPd) In Multiple Myeloma Patients Previously Exposed to Daratumumab

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, non-randomized, phase 2 study in which patients will receive daratumumab (subcutaneous, SC) in combination with clarithromycin/pomalidomide/dexamethasone (D-ClaPd) until progressive disease (PD) or unacceptable toxicity. This study will test the hypothesis that in patients with previous daratumumab exposure, combination therapy of clarithromycin/pomalidomide/dexamethasone with daratumumab SC (D-ClaPd) will yield higher Very Good Partial Response (VGPR) rates in relapsed/refractory multiple myeloma patients than historical pomalidomide/dexamethasone treatment.

Conditions

• Multiple Myeloma
• Refractory Multiple Myeloma
• Relapse Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Daratumumab SC	Given as 1800mg via injection
DRUG	Clarithromycin	Given as 500mg oral capsule
DRUG	Pomalidomide	Given as 4mg oral capsule
DRUG	Dexamethasone	Given as 20mg IV and 20mg or 40mg oral tablets

Timeline

• Start date: 2021-10-28
• Primary completion: 2025-12-28
• Completion: 2027-12-28
• First posted: 2020-03-10
• Last updated: 2025-10-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study