Spots Global Cancer Trial Database for Efficacy and Safety Study of Pembrolizumab (MK-3475) in Combination With Daratumumab in Participants With Relapsed Refractory Multiple Myeloma (MK-3475-668/KEYNOTE-668)
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Trial Identification
Brief Title: Efficacy and Safety Study of Pembrolizumab (MK-3475) in Combination With Daratumumab in Participants With Relapsed Refractory Multiple Myeloma (MK-3475-668/KEYNOTE-668)
Official Title: A Phase 2 Study of Pembrolizumab in Combination With Daratumumab (Anti CD38) in Participants With Relapsed Refractory Multiple Myeloma (rrMM)
Study ID: NCT03221634
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic Jacksonville ( Site 0003), Jacksonville, Florida, United States
Emory University School of Medicine ( Site 0002), Atlanta, Georgia, United States
Karmanos Cancer Institute ( Site 0001), Bloomfield Hills, Michigan, United States
Calgary Lab Services - Foothills Medical Centre ( Site 0105), Calgary, Alberta, Canada
Cross Cancer Institute ( Site 0104), Edmonton, Alberta, Canada
Capital Health Queen Elizabeth II Health Sciences Centre ( Site 0101), Halifax, Nova Scotia, Canada
Hopital Maisonneuve-Rosemont [Montreal, Canada] ( Site 0102), Montreal, Quebec, Canada
McGill University Health Centre ( Site 0100), Montreal, Quebec, Canada
CHU de Quebec - Hopital de l'Enfant-Jesus ( Site 0106), Quebec, , Canada
CHRU Lille Hospital Claude Huriez ( Site 0200), Lille, , France
Hopital Saint-Louis ( Site 0202), Paris, , France
Centre Hopitalier Lyon Sud ( Site 0201), Pierre Benite, , France
Rambam Medical Center ( Site 0700), Haifa, , Israel
Rabin Medical Center ( Site 0702), Petah-Tikva, , Israel
Sourasky Medical Center ( Site 0701), Tel Aviv, , Israel
Sheba MC ( Site 0703), Tel Hashomer, , Israel
Hospital Universitari Germans Trias i Pujol ( Site 0302), Badalona, , Spain
Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 0303), Hospitalet de Llobregat, , Spain
Clinica Universitaria de Navarra ( Site 0301), Pamplona, , Spain
Hospital Clinico Universitario de Salamanca ( Site 0300), Salamanca, , Spain
Hospital Clinico Universitario de Valencia ( Site 0304), Valencia, , Spain
Skaenes Universitetssjukhus Lund ( Site 0500), Lund, , Sweden
Karolinska Universitetssjukhuset ( Site 0501), Stockholm, , Sweden
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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