Isatuximab, Carfilzomib, and Pomalidomide for the Treatment of Relapsed or Refractory Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT04850599|
Recruitment Status : Not yet recruiting
First Posted : April 20, 2021
Last Update Posted : September 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Plasma Cell Myeloma Refractory Plasma Cell Myeloma||Drug: Carfilzomib Biological: Isatuximab Drug: Pomalidomide||Phase 2|
I. To assess the rate of response following treatment with isatuximab combined with carfilzomib and pomalidomide (isatuximab [Isa] carfilzomib [Car] pomalidomide [Pom]).
I. To evaluate the safety profile of the IsaCarPom combination. II. To assess duration of disease response following treatment with the IsaCarPom regimen.
III. To assess depth of IsaCarPom treatment as it relates to timing of subsequent therapies.
IV. To assess progression-free survival associated with IsaCarPom. V. To assess overall survival associated with IsaCarPom.
I. To molecularly assess the depth of IsaCarPom treatment by measuring minimal residual disease (MRD).
Patients receive isatuximab intravenously (IV) over 30-60 minutes on days 1, 8, 15, and 22 of cycle 1, and days 1 and 15 of subsequent cycles, carfilzomib IV over 10 to 30 minutes on days 1, 8, 15, and pomalidomide orally (PO) once daily (QD) on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 12 weeks for up to 24 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-Arm Phase II Study of Isatuximab With Carfilzomib and Pomalidomide in Relapsed or Refractory Multiple Myeloma|
|Estimated Study Start Date :||November 15, 2021|
|Estimated Primary Completion Date :||February 25, 2026|
|Estimated Study Completion Date :||February 21, 2029|
Experimental: Treatment (isatuximab, carfilzomib, pomalidomide)
Patients receive isatuximab IV over 30-60 minutes on days 1, 8, 15, and 22 of cycle 1, and days 1 and 15 of subsequent cycles, carfilzomib IV over 10 to 30 minutes on days 1, 8, 15, and pomalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Overall response rate (ORR) [ Time Frame: Up to end of cycle 4 (each cycles is 28 days), disease progression, start of new anti-myeloma therapy, or death (whichever occurs first) ]Defined as the proportion of participants who achieve a response >= partial response (PR) (i.e., PR, very good partial response, complete response, or stringent complete response) according to International Myeloma Working Group criteria. ORR will be measured from start of study treatment (i.e., cycle 1 day 1) to the earliest of the following events: end of cycle 4, start of new anti-myeloma therapy, documented disease progression, or death. Will be evaluated using the response-evaluable analysis set. A point estimate and exact 95% confidence interval will be provided.
- Incidence of grade > 2 toxicities [ Time Frame: Up to 30 days after discontinuing study treatment ]Evaluated per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. Descriptive statistics will be used to summarize all on-study adverse events (AEs), grade 3-4 AEs, treatment-related AEs, grade 3-4 treatment-related AEs, SAEs, treatment-related severe (S)AEs, and AEs leading to study therapy discontinuation. Grade 3-4 laboratory abnormalities will be summarized using worst grade NCI CTCAE v5.0 criteria.
- Duration of response (DOR) [ Time Frame: From initial disease response (>= PR) until disease progression, disease-related death, death from other cause (competing risk), or end of follow-up (censored), whichever occurs first, assessed up to 24 months ]Defined for participants with a confirmed response (>= PR) as the time between first documentation of response and disease progression according to IMWG criteria or death due to disease, whichever occurs first. Will be analyzed using the response-evaluable analysis set. Since non-progression, non-multiple myeloma (MM)-related death is a competing risk when assessing DOR, this endpoint will be estimated by cumulative incidence functions (one for progression or MM-related death, one for non-progression death) and modeled with Fine-Gray sub-distribution hazard regression.
- Time to next treatment [ Time Frame: From start of study regimen until start of new anti-myeloma therapy, death from any cause before new therapy, or end of follow-up (censored), whichever occurs first, assessed up to 24 months ]Will be estimated by the Kaplan-Meier method and modeled with Cox regression.
- Progression-free survival [ Time Frame: From start of study treatment until disease progression, death, or end of follow-up (censored), whichever occurs first, assessed up to 24 months ]Will be analyzed using the response-evaluable analysis set. Will be estimated by the Kaplan-Meier method and modeled with Cox regression.
- Overall survival [ Time Frame: From start of study treatment until death or last known alive (censored), assessed up to 24 months ]Will be estimated by the Kaplan-Meier method and modeled with Cox regression.
- Frequency of minimal residual disease negative remissions at time of complete response [ Time Frame: First post-baseline bone marrow or aspirate until last standard of care bone marrow biopsy on study (including follow-up), assessed up to 24 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): NCT04850599
|United States, Oregon|
|OHSU Knight Cancer Institute|
|Portland, Oregon, United States, 97239|
|Contact: Rebecca W. Silbermann 503-494-5304 email@example.com|
|Principal Investigator: Rebecca W. Silbermann|
|Principal Investigator:||Rebecca W Silbermann||OHSU Knight Cancer Institute|