Belantamab Mafodotin, Pomalidomide and Dexamethasone for the Treatment of High-Risk Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05208307|
Recruitment Status : Recruiting
First Posted : January 26, 2022
Last Update Posted : July 22, 2022
|Condition or disease||Intervention/treatment||Phase|
|Plasma Cell Myeloma||Biological: Belantamab Mafodotin Drug: Dexamethasone Drug: Pomalidomide||Phase 2|
I. To evaluate the efficacy of the combination of belantamab mafodotin, pomalidomide and dexamethasone (BPd) by assessing the >= complete response (CR) rates with BPd maintenance in patients with high-risk myeloma by International Myeloma Working Group (IMWG) criteria.
I. To evaluate the safety and tolerability of the combination of BPd in patients with high-risk myeloma.
II. To determine the antitumor activity of BPd maintenance among high-risk myeloma patients.
I. To evaluate the changes in microenvironment among patients receiving BPd maintenance.
Patients receive belantamab mafodotin intravenously (IV) over 30 minutes on day 1 of every other cycle, pomalidomide orally (PO) once daily (QD) on days 1-21, and dexamethasone PO QD on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Maintenance Therapy With Belantamab, Pomalidomide and Dexamethasone (BPd) in High-Risk Myeloma Patients: A Phase 2 Study With a Safety Run-In|
|Actual Study Start Date :||July 21, 2022|
|Estimated Primary Completion Date :||October 21, 2024|
|Estimated Study Completion Date :||October 21, 2024|
Experimental: Treatment (belantamab mafodotin, pomalidomide, dexamethasone)
Patients receive belantamab mafodotin IV over 30 minutes on day 1 of every other cycle, pomalidomide PO QD on days 1-21, and dexamethasone PO QD on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Biological: Belantamab Mafodotin
- Complete response rate [ Time Frame: Up to 3 years ]Assessed per International Myeloma Working Group criteria (best response during maintenance therapy).
- Incidence of adverse events [ Time Frame: Up to 3 years ]Toxicities of all patients will be tabulated as frequency and percentage. To evaluate the safety of the belantamab mafodotin, pomalidomide and dexamethasone (BPd) combination in the maintenance setting, proportion of safe patients will be estimated and its 95% confidence interval (CI) will be constructed by assuming binomial distribution. Adverse events will be graded using Common Terminology Criteria for Adverse Events (version 5.0).
- Very good partial response rate with BPd maintenance [ Time Frame: Up to 3 years ]Will be calculated as the proportion with 95% CI, assuming binomial distribution.
- Stringent complete response rate with BPd maintenance [ Time Frame: Up to 3 years ]Will be calculated as the proportion with 95% CI, assuming binomial distribution.
- Overall response with BPd maintenance [ Time Frame: Up to 3 years ]Will be calculated as the proportion with 95% CI, assuming binomial distribution.
- Progression free survival [ Time Frame: Up to 3 years ]Will be estimated with standard Kaplan-Meier method.
- Duration of response [ Time Frame: Up to 3 years ]Will be summarized with median and range.
- Overall survival (OS) [ Time Frame: Up to 3 years ]Will be estimated with standard Kaplan-Meier method. Both point and 95% CI of the median and other statistics (e.g., 6-month rate, 12-month rate, etc.) of OS will be calculated.
- Minimal residual disease (MRD) negativity rate [ Time Frame: Up to 3 years ]MRD detection will summarized using descriptive.
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): NCT05208307
|Contact: Ajay K. Nooka, MD,MPH,FACP||(404) firstname.lastname@example.org|
|United States, Georgia|
|Emory University/Winship Cancer Institute||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Bryan Burton 404-778-1780 email@example.com|
|Principal Investigator: Ajay K. Nooka, MD,MPH,FACP|
|Principal Investigator:||Ajay K. Nooka, MD,MPH,FACP||Emory University/Winship Cancer Institute|