NCT03158688: Phase 3 - Carfilzomib, Daratumumab and Dexa for relapsed Multiple Myeloma. (CANDOR)

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

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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

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Dexamethasone : National Cancer Institute

Dexamethasone : MedlinePlus Drug Information

Carfilzomib : National Cancer Institute

Carfilzomib : MedlinePlus Drug Information

Daratumumab : National Cancer Institute

Daratumumab : MedlinePlus Drug Information

Drug: Dexamethasone

Drug: Daratumumab (Darzalex)

Drug: Carfilzomib (Kyprolis)

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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)

https://doi.org/10.1182/blood-2019-132629

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

https://doi.org/10.1182/blood-2020-133908

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.

https://ash.confex.com/ash/2020/webprogram/Paper141995.html

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PMID: 32682484

Lancet; July 2020

Carfilzomib, dexamethasone, and daratumumab versus carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma (CANDOR): results from a randomised, multicentre, open-label, phase 3 study

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

Efficacy and safety of weekly carfilzomib (70 mg/m 2), dexamethasone, and daratumumab (KdD70) is comparable to twice-weekly KdD56 while being a more convenient dosing option: a cross-study comparison of the CANDOR and EQUULEUS studies

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- 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

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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