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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

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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