Evaluate the efficacy and safety of Belantamab Mafodotin, cyclophosphamide, and dexamethasone in patients with Relapsed/Refractory Multiple Myeloma
This is a Phase I/II, open-label study to evaluate the efficacy and safety of Belantamab Mafodotin, cyclophosphamide, and dexamethasone. In Phase I, the subjects will be assigned into two arms and there are two dose levels for Belantamab Mafodotin and there are two dose levels of cyclophosphamide in each arm. In Phase II, once tolerability of the highest planned dose is established, the patients will be assessed for response rate. The arm with acceptable toxicity and best response will be further assessed in the expansion cohort. Belantamab mafodotin was approved by the U.S. Food and Drug Administration (FDA) on Aug 5, 2020, for treating patients with relapsed/refractory multiple myeloma. Cyclophosphamide and dexamethasone are both approved by the FDA. But the combinations with these three drugs to treat people with relapsed/refractory multiple myeloma has not been approved by the FDA.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Study drug
University of Maryland
Baltimore, Maryland, United States
Number of Participants With Adverse Events in Dose Escalation
Overall incidence and severity of Adverse Events in Number of Participants with Adverse Events in Dose Escalation
Time frame: Up to 6 weeks
Response Rate in Dose Escalation and Expansion Cohort
Number of Participants With response rate in Dose Escalation and Expansion Cohort. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Up to 12 weeks
Number of Participants With Disease Progression
Number of participants with disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time frame: From date of randomization until the date of death from any cause, assessed up to 3 years
Number of Participants According to Best Response
Best Response (Not including Overall Survival (OS) response)
Time frame: From date of randomization until the date of death from any cause, assessed up to 3 years
Overall Survival
Number of patients with overall survival response
Time frame: From date of randomization until the date of death from any cause, assessed up to 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.