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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05922501
Other study ID # 23-183
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date June 18, 2024
Est. completion date December 1, 2026

Study information

Verified date January 2024
Source Massachusetts General Hospital
Contact Andrew Yee, MD
Phone 617-724-4000
Email AYEE1@mgh.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main goal of this phase II study is to evaluate the overall response rate of isatuximab, belantamab mafodotin, pomalidomide, and dexamethasone in relapsed and refractory multiple myeloma. The study drugs provided for research purposes are isatuximab and belantamab mafodotin.


Description:

This is a phase II study of isatuximab, belantamab mafodotin, pomalidomide, and dexamethasone in relapsed and refractory multiple myeloma. Approximately 50 participants will take part in this research study. The primary objective is determining the overall response rate of the treatment. Treatment is until progression, adverse events, or withdrawal of consent.


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Study Design


Intervention

Drug:
Isatuximab
An IgG1-derived monoclonal antibody that targets CD38 proteins, administered intravenously.
Belantamab mafodotin
An antibody-drug conjugate that is the combination of an antibody targeting BCMA and a drug, administered intravenously.
Pomalidomide
An immunomodulatory agent, capsule taken orally.
Dexamethasone
A glucocorticoid which is a substance that stops inflammation cause by immune system disorders, tablet taken orally.

Locations

Country Name City State
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Massachusetts General Hospital GlaxoSmithKline, Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Response Rate (ORR) Evaluated per International Myeloma Working Group Response Criteria 4 weeks
Secondary Number of Adverse Events Adverse events will be classified and graded according to the CTCAE v.5.0. Frequencies of adverse events will be summarized on all patients who receive any study drug. 4 weeks
Secondary Progression Free Survival (PFS) PFS is defined as the time from start of treatment to disease progression or death from any cause. Patients who have not progressed or died are censored at the date last known progression-free. This is estimated using the Kaplan-Meier method. The time from start of treatment to disease progression or death from any cause, for up to 10 years. Patients who have not progressed or died are censored at the date last known progression-free.
Secondary Overall survival (OS) OS is defined as the time from start of treatment to death due to any cause or censored at date last known alive. This is estimated using the Kaplan-Meier method. 4 weeks
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