Belantamab Mafodotin and Lenalidomide for the Treatment of Multiple Myeloma in Patients With Minimal Residual Disease Positive After Stem Cell Transplant
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|ClinicalTrials.gov Identifier: NCT04876248|
Recruitment Status : Not yet recruiting
First Posted : May 6, 2021
Last Update Posted : September 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Plasma Cell Myeloma||Biological: Belantamab Mafodotin Drug: Lenalidomide||Phase 2|
I. Assess the minimal residual disease (MRD) negative rate at the end (after 12 months) of consolidation with belantamab mafodotin in combination with lenalidomide post autologous stem cell transplantation.
I. Assess sustained MRD negative rate, progression free survival (PFS) and overall survival (OS).
Patients receive belantamab mafodotin intravenously (IV) over 30 minutes on day 1 and lenalidomide orally (PO) once daily (QD) on days 1-28. Treatment repeats every 8 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 12 weeks and the periodically for up to 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Trial of Belantamab Mafodotin Consolidation Treatment in Patients With Multiple Myeloma and MRD Positivity After Autologous Stem Cell Transplantation|
|Estimated Study Start Date :||October 1, 2021|
|Estimated Primary Completion Date :||December 5, 2023|
|Estimated Study Completion Date :||December 5, 2024|
Experimental: Treatment (belantamab mafodotin, lenalidomide)
Patients receive belantamab mafodotin IV over 30 minutes on day 1 and lenalidomide PO QD on days 1-28. Treatment repeats every 8 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.
Biological: Belantamab Mafodotin
- Minimal residual disease (MRD) negative rate [ Time Frame: After 6 cycles of post-transplant consolidation with belantamab mafodotin and lenalidomide (1 cycle = 8 weeks) ]A 90% confidence interval about true 6-month post-consolidation MRD negative rate will be obtained.
- Sustained MRD negative rate [ Time Frame: At 1 year after end of consolidation ]
- Progression-free survival [ Time Frame: Time from the start of consolidation therapy until disease progression death, due to disease, or last disease evaluation, assessed up to 5 years ]Will be summarized using standard Kaplan-Meier methods, with estimates of the median obtained with 90% confidence intervals.
- Overall survival [ Time Frame: Time from the start of consolidation until death due to any cause or last follow-up, assessed up to 5 years ]Will be summarized using standard Kaplan-Meier methods, with estimates of the median obtained with 90% confidence intervals.
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): NCT04876248
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|Contact: Jens Hillengass 716-845-3863 Jens.Hillengass@roswellpark.org|
|Principal Investigator: Jens Hillengass|
|Principal Investigator:||Jens Hillengass||Roswell Park Cancer Institute|