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

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT04302324
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 28, 2021
Status verified
May 2026
Primary completion
May 31, 2024
Completion
Dec 28, 2027

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: daratumumab/clarithromycin/pomalidomide/dexamethasone
    Induction Phase: 8 cycles (cycle length of 28 days) * Daratumumab SC: 1800mg SC weekly for 8 weeks for Cycle 1 and 2 1800mg SC every 2 weeks on Day 1 and 15 for Cycle 3-6 1800mg SC every 4 weeks on Day 1 for Cycle 7-8 * Clarithromycin 500mg PO BID until VGPR or 8 cycles, whichever occurs first * Pomalidomide 4mg PO on Days 1-21 * Dexamethasone 20mg IV as pre-medication on Day 1, 8 40mg PO on the day after daratumumab for Cycle 1 Days 15 and 22 40mg PO pre-daratumumab weekly for Cycle 2-6 20mg PO pre-daratumumab weekly for Cycle 7-8 Maintenance Phase (Cycle 9+): Up to 24 cycles (cycle length of 28 days) * Daratumumab 1800 mg SC on Day 1 * Pomalidomide 4mg PO on Day 1-21 * Dexamethasone 20mg PO pre-daratumumab weekly for Cycles 9 and beyond

Primary Outcome Measure

Very Good Partial Response Rate or Better Within 8 Cycles of Induction Therapy [ Time Frame: up to end of 8th induction cycle (up to approximately 224 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell Medicine - Multiple Myeloma CenterNew YorkNew York10065-

Find similar trials in New York, NY

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Weill Cornell Medicine - Multiple Myeloma Center· New York, NY

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