Study of Dara-Pembro for Multiple Myeloma Patients

Phase 2

Withdrawn

• Conditions: Multiple Myeloma
• Interventions: Drug: Pembrolizumab

• Registration Number: NCT04361851
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

This is a phase II, single-arm, open-label study in subjects with relapsed and/or refractory multiple myeloma (RRMM) comparing Pembrolizumab (Pembro) in combination with Daratumumab (Dara) to the historical control of Daratumumab.

Detailed Description

Heavily pre-treated multiple myeloma patients who are treated with single agent daratumumab have been reported to have median PFS of 4 months. A median PFS of 4 months corresponds to an 8-month progression-free survival rate of 25% (based on the exponential survival distribution). For this population of patients treated with Daratumumab and Pembrolizumab, the aim is to improve the 8-month PFS rate to 50%. Thirty-three RRMM patients who have received ≥ 3 lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) will be eligible for enrollment. Sixteen (16) subjects will be enrolled in the first stage, and if at least 5 of the 16 patients are alive and progression free at 8 months, an additional 17 subjects will be enrolled.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2020-04-22
• Study First Submitted QC: 2020-04-22
• Study First Posted: 2020-04-24
• Study Start: 2021-06-09
• Status Verified: 2022-01
• Last Update Submitted: 2022-04-20
• Last Update Posted: 2022-04-26
• Primary Completion: 2027-05
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Pembrolizumab	Pembrolizumab and Daratumumab

Primary Outcome Measures

Name	Time	Method
8-Month Progression-Free Survival (PFS8)	8 months	PFS8 will be determined for each subject as a binary variable indicating whether or not the subject is alive and progression free at 8 months.

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	up to 5 years	PFS is defined as the duration of time from the initiation of study treatment to first occurrence of either progressive disease or death.
Duration of Response (DOR)	up to 5 years	DoR will be calculated for those subjects who achieve a PR or better and is defined as the time first occurrence of PR (or better) until the time of disease progression or death.
Time to First Response (TTFR)	up to 5 years	TTFR is defined as the time from the start of study treatment to the time when the first occurrence of a MR or better was achieved.
Complete Response (CR) Rate	up to 5 years	CR will be determined for each subject as a binary variable indicating whether or not the specific level of response was achieved.
Overall Survival (OS)	up to 5 years	OS is defined as the duration from initiation of study treatment to the date of death from any cause.
Stringent Complete Response (sCR) Rate	up to 5 years	sCR will be determined for each subject as a binary variable indicating whether or not the specific level of response was achieved.
Time to Best Response (TTBR)	up to 5 years	TTBR is defined as the time from the start of study treatment to the time when the best response of MR or better was achieved.
Clinical Benefit Rate (CBR)	up to 5 years	CBR (achieving a minimal response or better) will be determined for each subject as a binary variable indicating whether or not the specific level of response was achieved.
Overall Response Rate (ORR)	up to 5 years	ORR (achieving a PR or better) will be determined for each subject as a binary variable indicating whether or not the specific level of response was achieved.