CPD-DARA in Patients With Relapsed/Refractory Multiple Myeloma. (CPD-DARA)
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|ClinicalTrials.gov Identifier: NCT04667663|
Recruitment Status : Recruiting
First Posted : December 16, 2020
Last Update Posted : January 25, 2023
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Daratumumab Drug: Cyclophosphamide Drug: Pomalidomide Drug: Dexamethasone||Phase 1|
Primary Objective 1. To determine the MTD and RP2D for pomalidomide that can safely be administered with DARA and cyclophosphamide.
1. To determine the incidence of DLT within the first cycle of CPD in combination with DARA at each dose level.
- To evaluate the safety and tolerability of the CPD-DARA regimen.
- To evaluate efficacy measures. Secondary Endpoints
1. Safety will be assessed by standard clinical and laboratory tests (haematology, serum chemistry). Adverse events grade will be defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 5.0.
2. The following efficacy endpoints will be measured: i. Complete Response (CR) rate after six cycles of CPD-DARA and at the end of study treatment.
ii. Best Overall Response. iii. Minimal Residual Disease (MRD) negative rate after six cycles of CPD-DARA. iv. Progression Free Survival (PFS) and Overall Survival (OS) at 6 months and 2 years.
v. Time to Response. Exploratory Objectives
- To assess effect of CPD-DARA treatment on patient-reported outcomes and quality of life.
- Efficacy according to the IMWG (International Myeloma Working Group) in High Risk vs Standard Risk patients.
- Disease Control Rate (DCR). Exploratory Endpoints
1. To assess effect of CPD-DARA treatment on patient-reported outcomes and quality of life, as assessed by the FACT-G and MyPOS questionnaires completed at study commencement, at every cycle of study treatment and at completion of the study treatment.
2. Efficacy according to the IMWG in High Risk (defined by ISS stage 3 and/or high-risk cytogenetic findings including t(4;14), t(14;16), and del17p) vs Standard Risk patients.
3. Disease Control Rate (DCR) defined as stable disease or better.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase Ib of Cyclophosphamide, Pomalidomide, Dexamethasone and Daratumumab (CPD-DARA) in Patients With Relapsed/Refractory Multiple Myeloma. (The CPD-DARA Study)|
|Actual Study Start Date :||December 8, 2021|
|Actual Primary Completion Date :||April 29, 2022|
|Estimated Study Completion Date :||April 30, 2026|
Drug: Daratumumab Other Name: Darzalex
Drug: Pomalidomide Other Name: Pomalyst/ Imnovid
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.
Other Name: Darzalez
Cyclophosphamide will be administered PO at 50mg daily for all cohorts in the study.
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 will be administered PO at 40mg on days 1, 8, 15 and 22 of each 28 day cycle.
- Incidence of DLT within the first cycle of CPD in combination with DARA at each dose level. [ Time Frame: Up to cycle 1 ]
- MTD for pomalidomide that can safely be administered with DARA and cyclophosphamide. [ Time Frame: Through study treatment, an average of 1 months ]
- RP2D for pomalidomide that can safely be administered with DARA and cyclophosphamide. [ Time Frame: Through study treatment, an average of 1 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04667663
|Contact: Cancer Trials Ireland||+353 (0)1 email@example.com|
|Cork University Hospital||Recruiting|
|Contact: Vitaliy Mykytiv|
|Contact: John Quinn|
|Galway University Hospital||Recruiting|
|Contact: Janusz Krawczyk|