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

NCT04667663 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-04-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Daratumumab

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.

DRUG

Cyclophosphamide

Cyclophosphamide will be administered PO at 50mg daily for all cohorts in the study.

DRUG

Pomalidomide

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.

DRUG

Dexamethasone

Dexamethasone will be administered PO at 40mg on days 1, 8, 15 and 22 of each 28 day cycle.

Sponsors & Collaborators

  • Janssen Pharmaceuticals

    collaborator INDUSTRY

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Cancer Trials Ireland

    lead NETWORK

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-08
Primary Completion
2022-04-29
Completion
2026-04-30

Countries

  • Ireland

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04667663 on ClinicalTrials.gov