A Study of Daratumumab With Pomalidomide, Dexamethasone, and All-Transretinoic Acid in Patients With Multiple Myeloma

Part of paid clinical trials in Hackensack, New Jersey.

Sponsor
Hackensack Meridian Health
Study ID
NCT04700176
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab — DRUG
    During 28-day treatment cycles, patients will receive Dara 16 mg/kg intravenously (IV) at their current dose upon enrollment onto the study depending on their cycle. They will receive Dara depending on the cycle they are in. If they are on cycles 1-2 then they will receive Dara 16 mg/kg IV on days 1,8,15,22; if they are on cycles 3-6 they will receive Dara 16 mg/kg on days 1 and 15; and if they are on cycle 7 or beyond they will receive Dara 16 mg/kg on day 1.
  • Pomalidomide — DRUG
    Pomalidomide will be administered at the patient's currently tolerated dose (4,3, or 2 mg po daily) on days 1-21
  • All-trans retinoic acid — DRUG
    ATRA will be administered in a divided dose of twice daily as an oral formulation at 45mg/m2/day for 3 days. The first administration of ATRA will be given in the morning, two days before the scheduled Dara infusion. The last administration of ATRA will be given in the evening of the day that Dara was administered
  • Dexamethasone — DRUG
    Dexamethasone will be administered at 40 mg once weekly on days 1,8,15 for patients 75 years old and younger and at 20 mg once weekly on days 1,8,15 for patients older than 75.

Study Details

The purpose of this study is to test the safety and efficacy of the study drug daratumumab, when given together with Pomalidomide, Dexamethasone, and All-Transretinoic Acid (ATRA).

Key Dates

Start date
May 2, 2022
Status verified
Feb 2025
Primary completion
Nov 15, 2023
Completion
Nov 15, 2023

Study Design

Enrollment
1 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A)
    Patients with relapsed or refractory multiple myeloma who have progressed on the combination of Dara + Len + Dex (Cohort A) to be treated with a combination of Dara + Pom + Dex + ATRA (All-Transretinoic Acid)
  • Experimental: Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B)
    Patients with relapsed or refractory multiple myeloma who have progressed on the combination of Dara + Pom + Dex (Cohort B) to be treated with a combination of Dara + Pom + Dex + ATRA (All-Transretinoic Acid)

Primary Outcome Measure

Objective Response Rate (Cohort A) [ Time Frame: 12 Months ]

Locations (1)

FacilityCityStateZIPSite coordinators
John Theurer Cancer CenterHackensackNew Jersey07601-

Find similar trials in Hackensack, NJ

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
John Theurer Cancer Center· Hackensack, NJ

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