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

• ClinicalTrials.gov Identifier: NCT03158688
• Recruitment Status: Completed
• First Posted: May 18, 2017
• Results First Posted: September 11, 2020
• Last Update Posted: March 5, 2024
• Sponsor: Amgen
• Information provided by (Responsible Party): Amgen

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Relapsed Multiple Myeloma; Refractory Multiple Myeloma	Drug: Dexamethasone; Drug: Daratumumab; Drug: Carfilzomib	Phase 3

Detailed Description:

This is a phase 3 multicenter, open-label, randomized study in participants with relapsed or refractory multiple myeloma (RRMM) who have received 1 to 3 prior therapies.

Participants receive the treatment determined by randomization for a maximum of approximately 5 years, up to 30 days prior to the final analysis data cutoff (DCO) date or until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or death (whichever occurs first). No crossover between the treatment arms is allowed.

This was an open-label study. However, the assessment of response and disease progression for the primary analysis was determined by an Independent Review Committee (IRC) in a blinded manner. Sensitivity analyses of response and disease progression were determined centrally by the sponsor using a validated computer algorithm (Onyx Response Computational Assessment [ORCA]) in a blinded manner.

Following progression or discontinuation of study drug(s), participants will have 1 follow-up visit (30 days [+3} after last dose of all study drug[s]). After disease progression, data on survival status and subsequent antimyeloma therapy will be gathered at long-term follow-up (LTFU) visits every 12 weeks (+/-2 weeks) until the Final Analysis DCO.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 466 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: June 13, 2017
• Actual Primary Completion Date: July 14, 2019
• Actual Study Completion Date: April 15, 2022

Arms and Interventions

Arm	Intervention/treatment
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.	Drug: Dexamethasone; 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.; Drug: Carfilzomib; 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.; Other Name: KYPROLIS®
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.	Drug: Dexamethasone; 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.; Drug: Daratumumab; Daratumumab was supplied as a concentrated solution for infusion in single-use vials.; Other Name: DARZALEX®; Drug: Carfilzomib; 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.; Other Name: KYPROLIS®

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   Progression-free survival (PFS) was defined as the time from randomization to the earlier of disease progression or death due to any cause. Participants were evaluated for disease response and progression according to the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) as assessed by an Independent Review Committee (IRC). The duration of PFS was right censored for participants who met any of the following conditions: 1. no baseline/post-baseline disease assessments; 2. started a new anti myeloma therapy before documentation of progressive disease or death; 3. progressive disease or death immediately after more than 70 days without disease assessment visit or; 4. alive without documentation of disease progression before the analysis trigger date (PA DCO); 5. lost to follow-up or withdrawn consent.

Secondary Outcome Measures :

1. Overall Response (OR) 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 ]

   Overall response rate was defined as the percentage of participants in each treatment group who achieve partial response (PR) or better per the International Myeloma Working Group Uniform Response Criteria (IMWG-URC) as their best response.

   Complete Response (CR): No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow.

   Very Good Partial Response (VGPR): Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-component with urine M-component <100 mg/24 hours.

   Partial Response (PR): ≥ 50% reduction of serum M-protein and reduction in urine M-protein by ≥ 90% or to < 200 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline.

   95% CIs for proportions were estimated using the Clopper-Pearson method.

2. Minimal Residual Disease Negative Complete Response Rate (MRD[-]CR) at 12 Months as Assessed by the Independent Review Committee [ Time Frame: 12 Months (8- to 13-month window) ]
   MRD[-]CR at 12 months was defined as achievement of CR per IMWG-URC by IRC and MRD[-] status as assessed by next-generation sequencing (NGS; at a 10^-5 level) at the 12 months landmark (8 to 13 month window).
3. Overall Survival [ Time Frame: Up to 58 months after the first participant was enrolled (at FA DCO, a median of 40.29 weeks of treatment [any study drug] in the Kd group and 79.29 weeks of treatment [any study drug] in the KdD group; FA DCO was 15 Apr 2022) ]
   Overall survival was defined as the time from randomization until death from any cause. Deaths collected via public source, after end of study were included. Medians were estimated using the Kaplan-Meier method. 95% CIs for medians were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. Participants still alive were censored at the date last known to be alive.
4. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: PA DCO: the longest treatment duration as of the PA DCO was 102.3 weeks; FA DCO: the longest treatment duration as of the FA DCO was 236.3 weeks ]

   Treatment-emergent adverse events are defined as any adverse event with an onset after the administration of the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurs earlier.

   The severity of adverse events was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening; Grade 5 = Fatal.

   Treatment-related adverse events are treatment-emergent adverse events considered related to at least one study drug by the investigator, including those with unknown relationship.

5. Kaplan-Meier Estimate for Duration of Response (DOR) (PA DCO Only) [ Time Frame: From Day 1 until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks ]

   Duration of response (DOR) was defined as the time (in months) from first evidence of partial response (PR) or better per IMWG-URC by IRC to the earlier of disease progression or death due to any cause for participants with a best response of PR or better. For those who are alive and have not experienced disease progression at the time of data cutoff for analysis, duration of response was right-censored.

   Medians were estimated using the Kaplan-Meier method. 95% CIs for medians were estimated using the method by Klein and Moeschberger (1997) with log-log transformation.

6. Kaplan-Meier Estimate for Time to Next Treatment (TTNT) [ Time Frame: PA DCO: the longest treatment duration as of the PA DCO was 102.3 weeks; FA DCO: the longest treatment duration as of the FA DCO was 236.3 weeks ]

   Time to next treatment was defined as the time (in months) from randomization to the initiation of subsequent non-protocol anti-cancer treatment for multiple myeloma. Time to next treatment for participants who do not start the subsequent treatment for multiple myeloma was censored at the date when the participant's information was last available.

   Medians of TTNT duration were estimated using the Kaplan-Meier method. 95% CIs for medians were estimated using the method by Klein and Moeschberger (1997) with log-log transformation.

7. Kaplan-Meier Estimates for Time to Progression (TTP) 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 ]
   Time to progression was defined as the time (in months) from randomization to documented disease progression. Participants who did not have documented disease progression were censored at the date when data was last available.
8. Time to Progression (TTP): Percentage of Participants Who Had Not Had Disease Progression as Assessed by the Independent Review Committee at Months 3, 6, 12, and 18 (PA DCO Only) [ Time Frame: Randomization to Months 3, 6, 12, and 18 ]

   Time to progression was defined as the time (in months) from randomization to documented disease progression. This outcome reports TTP as the percentage of participants who were event free (that is, they had not had disease progression) at the specified time frames. Independent Review Committee assessment for this outcome measure was not planned after the primary analysis.

   95% CIs for event-free rates were estimated using the method by Kalbfleisch and Prentice (1980) with log-log transformation.

9. Time to Overall Response 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 ]
   Time to overall response was defined as the time from randomization to the earliest date a response of partial response (PR) or better as per IMWG-URC is first achieved and subsequently confirmed for participants with a best response of PR or better.
10. Percentage of Participants Who Achieved and Maintained a Minimal Residual Disease Negative Complete Response (MRD[-]CR) for 12 Months or More [ Time Frame: PA DCO: the longest treatment duration as of the PA DCO was 102.3 weeks; FA DCO: the longest treatment duration as of the FA DCO was 236.3 weeks ]

    A measure of the persistence of the CR (includes strict CR) per International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) and MRD[-] status as assessed by next-generation sequencing (NGS; at a 10^-5 level) for 12 months or more after achieving MRD[-]CR status.

    95% confidence intervals (CIs) for proportions were estimated using the Clopper-Pearson method.

11. Percentage of Participants With a Complete Response (CR) 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 ]
    The percentage of participants in each treatment group who achieved stringent complete response (sCR) or CR per IMWG-URC, as assessed by the IRC, as their best response is presented.
12. Percentage of Participants Who Achieved Minimal Residual Disease Negative (MRD[-]) Status as Assessed by Next Generation Sequencing at 12 Months [ Time Frame: 12 Months (8- to 13-month window) ]

    MRD[-] at 12-month was defined as achievement of MRD[-] status as assessed by next-generation sequencing (NGS; at a 10^-5 level) at the 12 months landmark (from 8 months to 13 months window).

    95% confidence intervals (CIs) for proportions were estimated using the Clopper-Pearson method.

13. Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose [ Time Frame: Baseline (Day 1 pre-dose) up to 236.3 weeks (longest treatment duration as of the FA DCO) ]

    Health-related quality of life was assessed with the use of the European Organization for Research and Treatment of Cancer Quality of Life Core Module (QLQ-C30) questionnaire, a validated instrument in multiple myeloma patients. Scores range from 0 to 100, with higher scores indicating better health related quality of life.

    QLQ-C30 questionnaire was administered prior to dosing every 28 ± 7 days starting from cycle 1 day 1 through first follow-up visit (30 days [+3] after last dose of all study drugs).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Criteria 1 Relapsed or progressive multiple myeloma after last treatment
• Criteria 2 Males or females ≥ 18 years of age
• Criteria 3 Measurable disease with at least 1 of the following assessed within 21 days prior to randomization:
• IgG multiple myeloma: serum monoclonal paraprotein (M-protein) level ≥ 1.0 g/dL,
• IgA, IgD, IgE multiple myeloma: serum M-protein level ≥ 0.5 g/dL,
• urine M-protein ≥ 200 mg/24 hours,
• in subjects without measurable serum or urine M- protein, serum free light chain (SFLC) ≥ 100 mg/L (involved light chain) and an abnormal serum kappa lambda ratio
• Criteria 4 Received at least 1 but not more than 3 prior lines of therapy for multiple myeloma (induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as 1 line of therapy
• Criteria 5 Prior therapy with carfilzomib is allowed as long as the patient had at least a partial response (PR) to most recent therapy with carfilzomib, was not removed due to toxicity, did not relapse within 60 days from discontinuation of carfilzomib, and will have at least a 6-month carfilzomib treatment-free interval from last dose received until first study treatment. (Patients may receive maintenance therapy with drugs that are not proteasome inhibitors or CD38 antibodies during this 6-month carfilzomib treatment free interval)
• Criteria 6 Prior therapy with anti-CD38 antibodies is allowed as long as the patient had at least a PR to most recent therapy with CD38 antibody, was not removed due to toxicity, did not relapse within 60 days from intensive treatment (at least every other week) of CD38 antibody therapy, and will have at least a 6 month CD38 antibody treatment-free interval from last dose received until first study treatment
• Other inclusion criteria may apply

Exclusion Criteria:

• Criteria 1 Waldenström macroglobulinemia
• Criteria 2 Multiple myeloma of IgM subtype
• Criteria 3 POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
• Criteria 4 Plasma cell leukemia (> 2.0 * 10^9/L circulating plasma cells by standard differential)
• Criteria 5 Myelodysplastic syndrome
• Criteria 6 Known moderate or severe persistent asthma within the past 2 years
• Criteria 7 Known chronic obstructive pulmonary disease (COPD) with a FEV1 < 50% of predicted normal
• Criteria 8 Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, uncontrolled arrhythmias, clinically significant electrocardiogram (ECG) abnormalities, screening ECG with corrected QT interval (QTc) of > 470 msec, pericardial disease, or myocardial infarction within 4 months prior to randomization
• Other exclusion criteria may apply

Contacts and Locations

Locations

United States, Florida

Lynn Cancer Center Boca Raton Regional Hospital, Lynn Cancer Institute

Boca Raton, Florida, United States, 33486

United States, Georgia

Emory University Winship Cancer Institute

Atlanta, Georgia, United States, 30322

United States, Illinois

University of Chicago Medical Center - Multiple Myeloma Research Consortium

Chicago, Illinois, United States, 60637-6613

United States, Indiana

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, United States, 46845

United States, Mississippi

Hattiesburg Clinic Hematology/Oncology

Hattiesburg, Mississippi, United States, 39401

United States, New Jersey

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

United States, New York

New York Presbyterian Hospital, Weill Cornell Medical College

New York, New York, United States, 10021

United States, North Carolina

Levine Cancer Institute

Charlotte, North Carolina, United States, 28204

United States, Ohio

Gabrail Cancer Center, LLC

Dover, Ohio, United States, 44622

United States, South Carolina

Charleston Oncology

Charleston, South Carolina, United States, 29414

United States, Texas

Baylor Charles A Sammons Cancer Center at Dallas

Dallas, Texas, United States, 75246

Australia, New South Wales

Liverpool Hospital

Liverpool, New South Wales, Australia, 2170

St Vincents Hospital Sydney

St Leonards, New South Wales, Australia, 2065

Westmead Hospital

Westmead, New South Wales, Australia, 2145

Australia, Queensland

Royal Brisbane and Womens Hospital

Herston, Queensland, Australia, 4029

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia, 4102

Australia, South Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia, 5000

Australia, Victoria

Epworth Healthcare

East Melbourne, Victoria, Australia, 3002

St Vincents Hospital Melbourne

Fitzroy, VIC, Victoria, Australia, 3065

Barwon Health, University Hospital Geelong

Geelong, Victoria, Australia, 3220

The Alfred Hospital

Melbourne, Victoria, Australia, 3004

Austria

Medizinische Universitaet Graz

Graz, Austria, 8036

Landeskrankenhaus Salzburg

Salzburg, Austria, 5020

Belgium

Ziekenhuis Netwerk Antwerpen Stuivenberg

Antwerpen, Belgium, 2060

Universitair Ziekenhuis Brussel

Brussel, Belgium, 1090

Grand Hôpital de Charleroi

Charleroi, Belgium, 6000

Universitair Ziekenhuis Gent

Gent, Belgium, 9000

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, Belgium, 3000

Bulgaria

University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

Plovdiv, Bulgaria, 4002

University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD

Sofia, Bulgaria, 1431

Specialized Hospital for Active Treatment of Hematology Diseases EAD

Sofia, Bulgaria, 1756

Canada, Alberta

Tom Baker Cancer Centre

Calgary, Alberta, Canada, T2N 4N2

Cross Cancer Institute

Edmonton, Alberta, Canada, T6G 1Z2

Canada, Ontario

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada, K1H 8L6

Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2M9

Canada, Quebec

Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada, H1T 2M4

Czechia

Fakultni nemocnice Brno

Brno, Czechia, 625 00

Fakultni nemocnice Hradec Kralove

Hradec Kralove, Czechia, 500 05

Fakultni nemocnice Ostrava

Ostrava-Poruba, Czechia, 708 52

Fakultni nemocnice Plzen

Plzen, Czechia, 304 60

Vseobecna fakultni nemocnice v Praze

Praha 2, Czechia, 128 08

France

Centre Hospitalier Départemental les Oudairies

La Roche Sur Yon Cedex 9, France, 85925

Centre Hospitalier de Versailles - Hopital Andre Mignot

Le Chesnay cedex, France, 78157

Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez

Lille Cedex, France, 59037

Centre Hospitalier Universitaire de Nantes

Nantes Cedex 1, France, 44093

Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque

Pessac Cedex, France, 33604

Centre Hospitalier Lyon Sud

Pierre-Benite cedex, France, 69495

Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie

Poitiers Cedex, France, 86021

Centre Hospitalier Universitaire de Nancy - Hopital de Brabois

Vandoeuvre les Nancy Cedex, France, 54511

Greece

General Hospital Evangelismos

Athens, Greece, 10676

Alexandra Hospital

Athens, Greece, 11528

General University Hospital of Patras Panagia i Voithia

Patra, Greece, 26504

Theagenion Cancer Hospital of Thessaloniki

Thessaloniki, Greece, 54007

Hungary

Bekes Megyei Kozponti Korhaz Dr Rethy Pal Tagkorhaz

Bekescsaba, Hungary, 5600

Semmelweis Egyetem

Budapest, Hungary, 1088

Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

Budapest, Hungary, 1097

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary, 4032

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar

Szeged, Hungary, 6725

Japan

Nagoya City University Hospital

Nagoya-shi, Aichi, Japan, 467-8602

Toyohashi Municipal Hospital

Toyohashi-shi, Aichi, Japan, 441-8570

Tesshokai Kameda General Hospital

Kamogawa-shi, Chiba, Japan, 296-8602

National Hospital Organization Kyushu Cancer Center

Fukuoka-shi, Fukuoka, Japan, 811-1395

Kyushu University Hospital

Fukuoka-shi, Fukuoka, Japan, 812-8582

Ogaki Municipal Hospital

Ogaki-shi, Gifu, Japan, 503-8502

Gunma University Hospital

Maebashi-shi, Gunma, Japan, 371-8511

National Hospital Organization Shibukawa Medical Center

Shibukawa-shi, Gunma, Japan, 377-0280

University Hospital Kyoto Prefectural University of Medicine

Kyoto-shi, Kyoto, Japan, 602-8566

Niigata Cancer Center Hospital

Niigata-shi, Niigata, Japan, 951-8566

National Hospital Organization Okayama Medical Center

Okayama-shi, Okayama, Japan, 701-1192

Osaka University Hospital

Suita-shi, Osaka, Japan, 565-0871

Saitama Medical Center

Kawagoe-shi, Saitama, Japan, 350-8550

Tochigi Cancer Center

Utsunomiya-shi, Tochigi, Japan, 320-0834

Tokushima Prefectural Central Hospital

Tokushima-shi, Tokushima, Japan, 770-8539

Cancer Institute Hospital of Japanese Foundation for Cancer Research

Koto-ku, Tokyo, Japan, 135-8550

Japanese Red Cross Medical Center

Shibuya-ku, Tokyo, Japan, 150-8935

Korea, Republic of

National Cancer Center

Goyang-si, Gyeonggi-do, Korea, Republic of, 10408

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, Korea, Republic of, 58128

Seoul National University Hospital

Seoul, Korea, Republic of, 03080

Severance Hospital Yonsei University Health System

Seoul, Korea, Republic of, 03722

Asan Medical Center

Seoul, Korea, Republic of, 05505

Samsung Medical Center

Seoul, Korea, Republic of, 06351

The Catholic University of Korea Seoul St Marys Hospital

Seoul, Korea, Republic of, 06591

Poland

InterHem

Bialystok, Poland, 15-732

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich w Chorzowie

Chorzow, Poland, 41-500

Centrum Onkologii Ziemi Lubelskiej im Swietego Jana z Dukli

Lublin, Poland, 20-090

Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K Marcinkowskiego w Poznaniu

Poznan, Poland, 60-569

Instytut Hematologii i Transfuzjologii

Warszawa, Poland, 02-776

Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wroclawiu

Wroclaw, Poland, 50-367

Romania

Policlinica de Diagnostic Rapid

Brasov, Romania, 500152

Fundeni Clinical Institute

Bucharest, Romania, 022328

Coltea Clinical Hospital

Bucharest, Romania, 030171

Spitalul Clinic Colentina

Bucuresti, Romania, 020125

Bucharest Emergency University Hospital

Bucuresti, Romania, 050098

Profesor Dr Ion Chiricuta Institut of Oncology

Cluj-Napoca, Romania, 400124

Spitalul Clinic Municipal Filantropia Craiova

Craiova, Romania, 200143

Russian Federation

SBHI of Nizhny Novgorod region Regional Clinical Hospital of Nizhny Novgorod na N A Semashko

Nizhny Novgorod, Russian Federation, 603126

SBHI of Republic of Karelia Republic Hosiptal n a V A Baranov

Petrozavodsk, Russian Federation, 185019

State Budget Educational Institution of High Professional Skills Samara State Medical University

Samara, Russian Federation, 443079

Clinic of professional pathology and hematology

Saratov, Russian Federation, 410028

Spain

Hospital Clinico Universitario de Salamanca

Salamanca, Castilla León, Spain, 37007

Hospital Universitari Germans Trias i Pujol

Badalona, Cataluña, Spain, 08916

Hospital Clinic i Provincial de Barcelona

Barcelona, Cataluña, Spain, 08036

Clinica Universidad de Navarra

Pamplona, Navarra, Spain, 31008

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Taiwan

National Taiwan University Hospital

Taipei, Taiwan, 10002

Taipei Veterans General Hospital

Taipei, Taiwan, 11217

Turkey

Hacettepe Universitesi Tip Fakultesi

Ankara, Turkey, 06100

Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

Ankara, Turkey, 06590

Ege University Faculty of Medicine

Izmir, Turkey, 35040

Ondokuz Mayis Universitesi Tip Fakultesi

Samsun, Turkey, 55139

United Kingdom

St James University Hospital

Leeds, United Kingdom, LS9 7TF

University College London Hospital

London, United Kingdom, NW1 2PG

Christie Hospital

Manchester, United Kingdom, M20 4BX

Sponsors and Collaborators

Amgen

Investigators

• Study Director: MD; Amgen

  Study Documents (Full-Text)

Documents provided by Amgen:

Study Protocol  [PDF] March 17, 2021

Statistical Analysis Plan  [PDF] July 15, 2019

More Information

Additional Information:

AmgenTrials clinical trials website 

Publications:

Quach H, Nooka A, Samoylova O, Venner CP, Kim K, Facon T, Spencer A, Usmani SZ, Grosicki S, Suzuki K, Delimpasi S, Weisel K, Obreja M, Zahlten-Kumeli A, Mateos MV. Carfilzomib, dexamethasone and daratumumab in relapsed or refractory multiple myeloma: results of the phase III study CANDOR by prior lines of therapy. Br J Haematol. 2021 Aug;194(4):784-788. doi: 10.1111/bjh.17541. Epub 2021 May 28. No abstract available.

Siegel D, Weisel K, Zahlten-Kumeli A, Medhekar R, Ding B, Leleu X. Health-related quality of life outcomes from the CANDOR study in patients with relapsed or refractory multiple myeloma. Leuk Lymphoma. 2021 Dec;62(12):3002-3010. doi: 10.1080/10428194.2021.1941927. Epub 2021 Jun 26.

Suzuki K, Min CK, Kim K, Lee JJ, Shibayama H, Ko PS, Huang SY, Li SS, Ding B, Khurana M, Iida S. Carfilzomib, dexamethasone, and daratumumab in Asian patients with relapsed or refractory multiple myeloma: post hoc subgroup analysis of the phase 3 CANDOR trial. Int J Hematol. 2021 Dec;114(6):653-663. doi: 10.1007/s12185-021-03204-9. Epub 2021 Aug 19.

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• Responsible Party: Amgen
• ClinicalTrials.gov Identifier: NCT03158688
• Other Study ID Numbers: 20160275; 2016-003554-33 ( EudraCT Number )
• First Posted: May 18, 2017
• Results First Posted: September 11, 2020
• Last Update Posted: March 5, 2024
• Last Verified: March 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
• URL: https://www.amgen.com/datasharing

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amgen:

Carfilzomib; Dexamethasone; Daratumumab

Additional relevant MeSH terms:

Multiple Myeloma; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Dexamethasone; Daratumumab; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents