Maintenance Belantamab Mafodotin (Blenrep®) After B-cell Maturation Antigen-Directed Chimeric Antigen Receptor T-cell Therapy in Patients With Relapsed and/or Refractory Multiple Myeloma (EMBRACE)
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|ClinicalTrials.gov Identifier: NCT05117008|
Recruitment Status : Recruiting
First Posted : November 11, 2021
Last Update Posted : August 4, 2022
|Condition or disease||Intervention/treatment||Phase|
|Refractory Multiple Myeloma Relapse Multiple Myeloma||Drug: Belantamab mafodotin||Phase 2|
Subjects will receive belantamab mafodotin as maintenance therapy. Belantamab mafodotin will be administered IV over approximately 30 minutes at the recommended dose of 2.5 mg/kg IV over 30 minutes on day 1 of every eight-week (+/- three days) cycle for a maximum of 12 cycles. Maintenance therapy with belantamab mafodotin will continue until progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or end of study (maximum of 12 cycles), whichever occurs first. Dose interruptions or reductions may be required to address potential drug-associated toxicities. The dose to be administered will be based on actual body weight calculated at baseline. However, if the change in body weight is greater than 10%, the dose will be recalculated based on the actual body weight at the time of dosing. The dose may be reduced to address toxicity.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Phase II Study of Maintenance Belantamab Mafodotin (Blenrep®) After BCMA-Directed Chimeric Antigen Receptor T-cell Therapy in Patients With Relapsed and/or Refractory Multiple Myeloma|
|Actual Study Start Date :||July 19, 2022|
|Estimated Primary Completion Date :||January 2027|
|Estimated Study Completion Date :||January 2032|
Experimental: belantamab mafodotin
Belantamab mafodotin is an intravenous drug.
Drug: Belantamab mafodotin
Belantamab mafodotin will be administered IV over approximately 30 minutes at the recommended dose of 2.5 mg/kg IV over 30 minutes on day 1 of every eight-week (+/- three days) cycle for a maximum of 12 cycles. Maintenance therapy with belantamab mafodotin will continue until progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or end of study (maximum of 12 cycles), whichever occurs first.
Other Name: Blenrep
- The number of patients with 12-month progression-free survival. [ Time Frame: 12 months ]The primary endpoint of the study is the 12-month progression-free survival (PFS) with time counted from the CAR-T infusion conditional on being alive and progression-free at day +90 post CAR-T. An event will be defined as documented progression or death for any cause, subjects without an event will be censored at the last date known to be alive without progression.
- Overall survival for the entire study population from the time of CAR-T administration. [ Time Frame: Up to 10 years ]The number of subjects alive at the completion of the study. In long-term follow-up, subjects will be evaluated every six 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): NCT05117008
|Contact: Medical College of Wisconsin Cancer Center Clinical Trials Office||866-680-0505 ext firstname.lastname@example.org|
|United States, Wisconsin|
|Froedtert & the Medical College of Wisconsin||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Meera Mohan, MD, MS 414-805-4600 email@example.com|
|Principal Investigator:||Meera Mohan, MD, MS||Medical College of Wisconsin|