The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) in combination with daratumumab in participants with relapsed refractory multiple myeloma (rrMM). The primary outcome measure for this study is the assessment of Objective Response Rate (ORR) in participants with rrMM.
Study treatment will continue until the participant has completed 35 infusions (approximately 2 years) of pembrolizumab treatment. All participants who stop study treatment with stable disease (SD) or better may be eligible for up to an additional \~1 year of study treatment if they progress after stopping study treatment from the initial treatment phase.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
IV infusion
IV infusion
Mayo Clinic Jacksonville ( Site 0003)
Jacksonville, Florida, United States
Objective Response Rate (ORR)
ORR is defined as the percentage of participants who experience a partial response (PR; ≥50% reduction of serum myeloma (M)-protein plus reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg per 24 hours) or better per International Myeloma Working Group (IMWG) 2016, based on investigator assessment.
Time frame: Up to approximately 2 years
Disease Control Rate (DCR)
DCR is defined as the percentage of participants who experience stable disease (SD; not meeting criteria for complete response, very good partial response, partial response, minimal response or progressive disease) or better prior to any evidence of progression, per IMWG 2016 based on investigator assessment.
Time frame: Up to approximately 2 years
Duration of Response (DOR)
DOR is defined as the time from first documented evidence of at least a PR (≥50% reduction of serum M-protein plus reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg per 24 hours) until disease progression or death, per IMWG 2016, based on investigator assessment.
Time frame: Up to approximately 2 years
Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants experiencing one or more AEs will be assessed.
Time frame: Up to approximately 27 months
Study Treatment Discontinuations Due to AEs
The number of participants discontinuing study treatment due to AEs will be assessed.
Time frame: Up to approximately 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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