Abbvie, M22-574, Ph3, open-label, Multiple Myeloma, ABBV-383 vs standard available therapies

What is the Purpose of this Study?

Primary Objective: To evaluate the efficacy, safety, and tolerability of ABBV-383 (a BCMA x CD3 bispecific antibody) administered as monotherapy in adult subjects with RRMM who have received at least 2 prior lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 mAb. In the Phase 1 study (TNB383B.0001/M22-466), ABBV-383 monotherapy demonstrated encouraging efficacy with a manageable safety profile in subjects with RRMM treated with >= 3 prior lines of therapy with exposure to PI, IMiD and an anti-CD38 mAb. As of 17 May 2023, a total of 220 subjects have been treated with ABBV-383 administered intravenously. At the 60 mg Q4W dose level (n = 21), the ORR and >= VGPR rates were 65% and 50%, respectively. Secondary Objectives: Statistical testing of the secondary endpoints will be performed only if the primary analysis of PFS is statistically significant. The key secondary endpoints are: - OS - Rate of >= VGPR per IRC assessment - Rate of >= CR per IRC assessment - Rate of MRD negativity with >= CR, defined as achievement of CR or better by IMWG (2016) response criteria (per IRC assessment) and MRD negative status as assessed by NGS Adaptive Clonoseq at 10-5 threshold - Change from baseline to 6 months in disease symptoms as measured by the disease symptoms domain of the EORTC QLQ-MY20 - Change from baseline to 6 months in physical functioning as measured by the physical functioning domain of the EORTC QLQ-C30


Eligibility

  • * Eastern Cooperative Oncology Group (ECOG) performance of \<= 2.
  • * Diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) during or after the participant's last treatment as stated in the protocol.
  • * Must have measurable disease with at least 1 of the following assessed within 28 days of enrollment:
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Where can I participate?

CS Cancer at Cedars-Sinai Medical Center : Emilie Douine-Barthelemy

More about this Clinical Trial

What is the full name of this clinical trial?

M22-574: A Phase 3, Multicenter, Randomized, Open-Label Study of ABBV-383 Compared with Standard Available Therapies in Subjects with Relapsed or Refractory Multiple Myeloma *

Study Details
Disease Type/Condition

Multiple Myeloma

Principal Investigator

Oveisi, David

Co-Investigators

Akil Merchant, Hannah Lee, Joshua Sasine, Justin Darrah, Noah Merin, Robert Vescio, Ronald Paquette

Age Group

Adult

Phase

III

IRB Number

STUDY00003270

ClinicalTrials.gov ID

NCT06158841

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Emilie Douine-Barthelemy

Email
emilie.douine-barthelemy@cshs.org
Study Detail
Disease Type/Condition

Multiple Myeloma

Principal Investigator

Oveisi, David

Age Group

Adult

Phase

III

IRB Number

M22-574

ClinicalTrials.gov ID

NCT06158841

Key Eligibility
ClinicalTrials.gov

Contact
Name

Emilie Douine-Barthelemy

Email
emilie.douine-barthelemy@cshs.org