Study of Carfilzomib, Daratumumab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma.

Part of paid clinical trials in Boca Raton, Florida.

Sponsor
Amgen
Study ID
NCT03158688
Phase
PHASE3
Status
Completed

Conditions

  • Refractory Multiple Myeloma
  • Relapsed Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dexamethasone — DRUG
    Commercially available oral and IV formulas were obtained by investigative sites. Amgen supplied IV or PO dexa for some countries (Poland, Hungry, Romania, Bulgaria, Korea). Dosage modification rules applied based on participant age (participants \> 75 years were given lower doses), dexa-related toxicities, and discontinuation of carfilzomib.
  • Daratumumab — DRUG
    Daratumumab was supplied as a concentrated solution for infusion in single-use vials.
  • Carfilzomib — DRUG
    Carfilzomib for infusion was supplied as a lyophilized, sterile product in single-use vials. The lyophilized product was reconstituted with preservative-free sterile water for injection, the reconstituted solution contained carfilzomib 2 mg/mL. IV injections lasted approximately 30 minutes. Dose could be modified based on a \>20% change in body weight or toxicity.

Study Details

Compare carfizomib, dexamethasone, and daratumumab (KdD) to Carfilzomib and dexamethasone (Kd) in terms of progression free survival (PFS) in participants with multiple myeloma who have relapsed after 1 to 3 prior therapies.

Key Dates

Start date
Jun 13, 2017
Status verified
May 2025
Primary completion
Jul 14, 2019
Completion
Apr 15, 2022

Study Design

Enrollment
466 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Kd - Carfilzomib and Dexamethasone
    Carfilzomib was administered intravenously (IV) at 20 mg/m\^2 in Cycle 1: days 1 and 2; at 56 mg/m\^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m\^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16. Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles.
  • Experimental: KdD - Carfilzomib, Dexamethasone and Daratumumab
    Carfilzomib was administered intravenously (IV) at 20 mg/m\^2 in Cycle 1: days 1 and 2; at 56 mg/m\^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m\^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16. Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles. The administration of dexamethasone was given on carfilzomib and/or daratumumab IV infusion days. Daratumumab was administered by IV at 8 mg/kg on Cycle 1: days 1 and 2; at 16 mg/kg on Cycle 1: days 8, 15 and 22, and Cycle 2: days 1, 8, 15, and 22. The 16 mg/kg dosage was continued on Cycles 3-6: days 1 and 15. The 16 mg/kg was further continued on Cycles 7+: day 1 only.

Primary Outcome Measure

Progression-free Survival (PFS) as Assessed by the Independent Review Committee (PA DCO Only) [ Time Frame: From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks ]

Locations (11)

FacilityCityStateZIPSite coordinators
Lynn Cancer Center Boca Raton Regional Hospital, Lynn Cancer InstituteBoca RatonFlorida33486-
Emory University Winship Cancer InstituteAtlantaGeorgia30322-
University of Chicago Medical Center - Multiple Myeloma Research ConsortiumChicagoIllinois60637-6613-
Fort Wayne Medical Oncology and HematologyFort WayneIndiana46845-
Hattiesburg Clinic Hematology/OncologyHattiesburgMississippi39401-
Hackensack University Medical CenterHackensackNew Jersey07601-
New York Presbyterian Hospital, Weill Cornell Medical CollegeNew YorkNew York10021-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Gabrail Cancer Center, LLCDoverOhio44622-
Charleston OncologyCharlestonSouth Carolina29414-
Baylor Charles A Sammons Cancer Center at DallasDallasTexas75246-

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By research site
Lynn Cancer Center Boca Raton Regional Hospital, Lynn Cancer Institute· Boca Raton, FLEmory University Winship Cancer Institute· Atlanta, GAUniversity of Chicago Medical Center - Multiple Myeloma Research Consortium· Chicago, ILFort Wayne Medical Oncology and Hematology· Fort Wayne, INHattiesburg Clinic Hematology/Oncology· Hattiesburg, MSHackensack University Medical Center· Hackensack, NJ

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