- Active, not recruiting
NCT03158688: Phase 3 - Carfilzomib, Daratumumab and Dexa for relapsed Multiple Myeloma. (CANDOR)
Updated: Jun 13, 2022
Phase 3 CANDOR study
Dara-Kd
Kd
Study of Carfilzomib, Daratumumab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma. (CANDOR)
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.
Sponsor
Amgen
Multiple locations
International study
ClinicalTrials.gov Identifier: NCT03158688
Official Title: A Randomized, Open-label, Phase 3 Study Comparing Carfilzomib, Dexamethasone, and Daratumumab to Carfilzomib and Dexamethasone for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma
First Posted : May 18, 2017
Click here for details on ClinicalTrials.gov
Drug: Dexamethasone
Drug: Daratumumab (Darzalex)
Drug: Carfilzomib (Kyprolis)
Late Breaking Abstracts| November 21, 2019
Carfilzomib, Dexamethasone, and Daratumumab Versus Carfilzomib and Dexamethasone for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma (RRMM): Primary Analysis Results from the Randomized, Open-Label, Phase 3 Study Candor (NCT03158688)
653.Myeloma/Amyloidosis: Therapy, excluding Transplantation| November 5, 2020
Carfilzomib, Dexamethasone, and Daratumumab Versus Carfilzomib and Dexamethasone in Relapsed or Refractory Multiple Myeloma: Subgroup Analysis of the Phase 3 Candor Study in Patients with Early or Late Relapse
1655 Carfilzomib 56mg/m2 Twice-Weekly in Combination with Dexamethasone and Daratumumab (KdD) Versus Daratumumab in Combination with 8 Cycles of Bortezomib and Dexamethasone (DVd); A Matching-Adjusted Indirect Treatment Comparison
Program: Oral and Poster Abstracts
Session: 905. Outcomes Research—Malignant Conditions (Lymphoid Disease): Poster I
Hematology Disease Topics & Pathways:
Diseases, Combinations, Lymphoid Malignancies
Saturday, December 5, 2020, 7:00 AM-3:30 PM
Conclusions: After adjusting for cross-trial differences, KdD was associated with a significant reduction in the risk of progression or death compared with DVd. Although based on an approach in agreement with methods guide, the results are associated with inherent limitations due to the decreased sample size for KdD, and due to known (longer follow-up for DVd, different duration of proteasome inhibition) or unobserved differences in the trials (potential unobserved heterogeneity in patient characteristics). A comparison of overall survival was not considered due to immature data in CANDOR. The results are in line with those of the head-to-head ENDEAVOR trial that directly compared carfilzomib with bortezomib (HR for PFS for Kd vs Vd 0.53; 95% CI: 0.44–0.65) supporting the clinical validity of this study. The present analysis suggests that KdD improves outcomes compared with DVd in patients with RRMM and may provide a rationale for a preferential treatment.
PMID: 32682484
Lancet; July 2020
PMID: 34046887
Br J Haematol; May 2021
Carfilzomib, dexamethasone and daratumumab in relapsed or refractory multiple myeloma: results of the phase III study CANDOR by prior lines of therapy
PMID: 33112184
Leuk Lymphoma; Feb 2021
- New York: Memorial Sloan-Kettering Cancer Center New York
- New York: New York Presbyterian / Weill Cornell Medical College New York
- North Carolina: Levine Cancer Institute Charlotte
- Georgia: Emory University Atlanta
- Illinois: University of Chicago
- New Jersey: Hackensack University Medical Center
- Texas: Baylor University Medical Center Dallas
Locations
United States, Florida
United States, Georgia
United States, Illinois
United States, Indiana
United States, Mississippi
United States, New Jersey
United States, New York
United States, North Carolina
United States, Ohio
United States, South Carolina
United States, Texas
Canada, Alberta
Canada, Ontario
Canada, Quebec
Australia, New South Wales
Australia, Queensland
Australia, South Australia
Australia, Victoria
Europe
United Kingdom
Austria
Belgium
Bulgaria
Czechia
France
Greece
Hungary
Poland
Romania
Spain
Turkey
Asia
Russian Federation
Japan
Korea, Republic of
Taiwan