CPD-DARA in Patients With Relapsed/Refractory Multiple Myeloma.

Sponsor
Cancer Trials Ireland
Study ID
NCT04667663
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Daratumumab — DRUG
    Daratumumab (1,800mg) will be administered by a subcutaneous injection once every week for 2 cycles (Cycles 1-2), then once every 2 weeks for 4 cycles (Cycles 3-6), and following this (Cycle 7 onwards), patients will receive daratumumab once every four weeks.
  • Cyclophosphamide — DRUG
    Cyclophosphamide will be administered PO at 50mg daily for all cohorts in the study.
  • Pomalidomide — DRUG
    Pomalidomide will be administered PO on days 1-21 of each 28 day cycle. The dose will be specified by the dose level to which the patient has been enrolled.
  • Dexamethasone — DRUG
    Dexamethasone will be administered PO at 40mg on days 1, 8, 15 and 22 of each 28 day cycle.

Study Details

This study is a Phase Ib, open label, single arm, adaptive multi-centre clinical study. The target population for this study are patients with relapsed/refractory multiple myeloma (MM). Patients will have a confirmed diagnosis of MM, with measurable disease as per IMWG criteria, in the second relapse and beyond (third line of therapy and beyond). Patients will need to have exposure to lenalidomide and a proteasome inhibitor. Patients will be treated with Cyclophosphamide-Pomalidomide-Dexamethasone (CPD) in combination with daratumumab (DARA) to determine the Maximum Tolerated Dose (MTD), Dose Limiting Toxicity (DLT) and Recommended Phase II Dose (RP2D) of the combination. Pomalidomide will be administered orally at three dose levels 4, 3 and 2mg on days 1-21 of each 28-day cycle. Treatment will be repeated on day 1 of a 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, physician's decision, or sponsor's decision to terminate the study, whichever occurs first.

Key Dates

Start date
Dec 8, 2021
Status verified
Apr 2026
Primary completion
Apr 29, 2022
Completion
Apr 30, 2026

Study Design

Enrollment
16 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CPD-DARA
    Drug: Daratumumab Other Name: Darzalex Drug: Cyclophosphamide Drug: Pomalidomide Other Name: Pomalyst/ Imnovid Drug: Dexamethasone

Primary Outcome Measure

Incidence of DLT within the first cycle of CPD in combination with DARA at each dose level. [ Time Frame: Up to cycle 1 ]

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