AzTrials
AzTrials

Relapsed Multiple MyelomaPhase 3CANDORNCT03158688

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

A Phase 3 study testing Dexamethasone, Daratumumab and Carfilzomib in people with Relapsed Multiple Myeloma and Refractory Multiple Myeloma, run by Amgen at 113 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dexamethasone, Daratumumab and Carfilzomib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
466 participants
Where
113 sitesin 19 countries
Study dates
13 Jun 2017to 15 Apr 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

113 sites in 19 countries.

113 sites in 19 countries

Japan17 sites

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, Fukuoka, 811-1395

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582

  • Tesshokai Kameda General Hospital

    Kamogawa-shi, Chiba, 296-8602

  • Saitama Medical Center

    Kawagoe-shi, Saitama, 350-8550

  • Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Koto-ku, Tokyo, 135-8550

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, Kyoto, 602-8566

  • Gunma University Hospital

    Maebashi, Gunma, 371-8511

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

  • Niigata Cancer Center Hospital

    Niigata, Niigata, 951-8566

  • Ogaki Municipal Hospital

    Ogaki-shi, Gifu, 503-8502

  • National Hospital Organization Okayama Medical Center

    Okayama, Okayama-ken, 701-1192

  • National Hospital Organization Shibukawa Medical Center

    Shibukawa-shi, Gunma, 377-0280

  • Japanese Red Cross Medical Center

    Shibuya-ku, Tokyo, 150-8935

  • Osaka University Hospital

    Suita-shi, Osaka, 565-0871

  • Tokushima Prefectural Central Hospital

    Tokushima, Tokushima, 770-8539

  • Toyohashi Municipal Hospital

    Toyohashi, Aichi-ken, 441-8570

  • Tochigi Cancer Center

    Utsunomiya, Tochigi, 320-0834

Other trials in Japan

United States11 sites

  • Emory University Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Lynn Cancer Center Boca Raton Regional Hospital, Lynn Cancer Institute

    Boca Raton, Florida, 33486

  • Charleston Oncology

    Charleston, South Carolina, 29414

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • University of Chicago Medical Center - Multiple Myeloma Research Consortium

    Chicago, Illinois, 60637-6613

  • Baylor Charles A Sammons Cancer Center at Dallas

    Dallas, Texas, 75246

  • Gabrail Cancer Center, LLC

    Dover, Ohio, 44622

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46845

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Hattiesburg Clinic Hematology/Oncology

    Hattiesburg, Mississippi, 39401

  • New York Presbyterian Hospital, Weill Cornell Medical College

    New York, New York, 10021

Other trials in United States

Australia10 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Epworth Healthcare

    East Melbourne, Victoria, 3002

  • St Vincents Hospital Melbourne

    Fitzroy, VIC, Victoria, 3065

  • Barwon Health, University Hospital Geelong

    Geelong, Victoria, 3220

  • Royal Brisbane and Womens Hospital

    Herston, Queensland, 4029

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • St Vincents Hospital Sydney

    St Leonards, New South Wales, 2065

  • Westmead Hospital

    Westmead, New South Wales, 2145

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

France8 sites

  • Centre Hospitalier Départemental les Oudairies

    La Roche-sur-Yon, 85925

  • Centre Hospitalier de Versailles - Hopital Andre Mignot

    Le Chesnay, 78157

  • Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez

    Lille, 59037

  • Centre Hospitalier Universitaire de Nantes

    Nantes, 44093

  • Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque

    Pessac, 33604

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie

    Poitiers, 86021

  • Centre Hospitalier Universitaire de Nancy - Hopital de Brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Romania7 sites

  • Policlinica de Diagnostic Rapid

    Brasov, 500152

  • Spitalul Clinic Colentina

    Bucharest, 020125

  • Fundeni Clinical Institute

    Bucharest, 022328

  • Coltea Clinical Hospital

    Bucharest, 030171

  • Bucharest Emergency University Hospital

    Bucharest, 050098

  • Profesor Dr Ion Chiricuta Institut of Oncology

    Cluj-Napoca, 400124

  • Spitalul Clinic Municipal Filantropia Craiova

    Craiova, 200143

Other trials in Romania

South Korea7 sites

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam-do, 58128

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591

Other trials in South Korea

Poland6 sites

  • InterHem

    Bialystok, 15-732

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich w Chorzowie

    Chorzów, 41-500

  • Centrum Onkologii Ziemi Lubelskiej im Swietego Jana z Dukli

    Lublin, 20-090

  • Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K Marcinkowskiego w Poznaniu

    Poznan, 60-569

  • Instytut Hematologii i Transfuzjologii

    Warsaw, 02-776

  • Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wroclawiu

    Wroclaw, 50-367

Other trials in Poland

Belgium5 sites

  • Ziekenhuis Netwerk Antwerpen Stuivenberg

    Antwerp, 2060

  • Universitair Ziekenhuis Brussel

    Brussels, 1090

  • Grand Hôpital de Charleroi

    Charleroi, 6000

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, 3000

Other trials in Belgium

Canada5 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Hopital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Czechia5 sites

  • Fakultni nemocnice Brno

    Brno, 625 00

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Fakultni nemocnice Ostrava

    Ostrava-Poruba, 708 52

  • Fakultni nemocnice Plzen

    Pilsen, 304 60

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

Other trials in Czechia

Hungary5 sites

  • Bekes Megyei Kozponti Korhaz Dr Rethy Pal Tagkorhaz

    Békéscsaba, 5600

  • Semmelweis Egyetem

    Budapest, 1088

  • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

    Budapest, 1097

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar

    Szeged, 6725

Other trials in Hungary

Spain5 sites

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Cataluña, 08916

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, Cataluña, 08036

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

  • Hospital Clinico Universitario de Salamanca

    Salamanca, Castilla León, 37007

Other trials in Spain

Greece4 sites

  • General Hospital Evangelismos

    Athens, 10676

  • Alexandra Hospital

    Athens, 11528

  • General University Hospital of Patras Panagia i Voithia

    Pátrai, 26504

  • Theagenion Cancer Hospital of Thessaloniki

    Thessaloniki, 54007

Other trials in Greece

Russia4 sites

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

    Nizhny Novgorod, 603126

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

    Petrozavodsk, 185019

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

    Samara, 443079

  • Clinic of professional pathology and hematology

    Saratov, 410028

Other trials in Russia

Turkey (Türkiye)4 sites

  • Hacettepe Universitesi Tip Fakultesi

    Ankara, 06100

  • Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

    Ankara, 06590

  • Ege University Faculty of Medicine

    Izmir, 35040

  • Ondokuz Mayis Universitesi Tip Fakultesi

    Samsun, 55139

Other trials in Turkey (Türkiye)

Bulgaria3 sites

  • University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

    Plovdiv, 4002

  • University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD

    Sofia, 1431

  • Specialized Hospital for Active Treatment of Hematology Diseases EAD

    Sofia, 1756

Other trials in Bulgaria

United Kingdom3 sites

  • St James University Hospital

    Leeds, LS9 7TF

  • University College London Hospital

    London, NW1 2PG

  • Christie Hospital

    Manchester, M20 4BX

Other trials in United Kingdom

Austria2 sites

  • Medizinische Universitaet Graz

    Graz, 8036

  • Landeskrankenhaus Salzburg

    Salzburg, 5020

Other trials in Austria

Taiwan2 sites

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

About this study

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

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.

Read the 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.

Keywords
Carfilzomib, Dexamethasone, Daratumumab
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexamethasoneDrug

    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.

  • DaratumumabDrug

    Also called DARZALEX®

    Daratumumab was supplied as a concentrated solution for infusion in single-use vials.

  • CarfilzomibDrug

    Also called KYPROLIS®

    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 groups in NCT03158688
Study groupRoleWhat they receive
Kd - Carfilzomib and DexamethasoneActive comparatorCarfilzomib 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.
Receives: Drug: Dexamethasone; Drug: Carfilzomib
KdD - Carfilzomib, Dexamethasone and DaratumumabExperimentalCarfilzomib 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.
Receives: Drug: Dexamethasone; Drug: Daratumumab; Drug: Carfilzomib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS) as Assessed by the Independent Review Committee (PA DCO Only)

    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.

    Measured: From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks

Secondary outcomes (13)

  1. Overall Response (OR) as Assessed by the Independent Review Committee (PA DCO Only)

    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.

    Measured: From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks

  2. Minimal Residual Disease Negative Complete Response Rate (MRD[-]CR) at 12 Months as Assessed by the Independent Review Committee

    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).

    Measured: 12 Months (8- to 13-month window)

  3. Overall Survival

    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.

    Measured: 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)

  4. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    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.

    Measured: 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

  5. Kaplan-Meier Estimate for Duration of Response (DOR) (PA DCO Only)

    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.

    Measured: From Day 1 until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks

  6. Kaplan-Meier Estimate for Time to Next Treatment (TTNT)

    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.

    Measured: 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

  7. Kaplan-Meier Estimates for Time to Progression (TTP) as Assessed by the Independent Review Committee (PA DCO Only)

    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.

    Measured: From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks

  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 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.

    Measured: Randomization to Months 3, 6, 12, and 18

  9. Time to Overall Response as Assessed by the Independent Review Committee (PA DCO Only)

    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.

    Measured: From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks

  10. Percentage of Participants Who Achieved and Maintained a Minimal Residual Disease Negative Complete Response (MRD[-]CR) for 12 Months or More

    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.

    Measured: 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

  11. Percentage of Participants With a Complete Response (CR) as Assessed by the Independent Review Committee (PA DCO Only)

    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.

    Measured: From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks

  12. Percentage of Participants Who Achieved Minimal Residual Disease Negative (MRD[-]) Status as Assessed by Next Generation Sequencing at 12 Months

    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.

    Measured: 12 Months (8- to 13-month window)

  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

    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).

    Measured: Baseline (Day 1 pre-dose) up to 236.3 weeks (longest treatment duration as of the FA DCO)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2017
  2. Study start13 Jun 2017
  3. Primary completion14 Jul 2019
  4. Study completion15 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
466 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03158688
Sponsor's protocol ID
20160275
Other IDs
2016-003554-33, 2016
Acronym
CANDOR
Status last verified
May 2025
First submitted
9 May 2017
Last updated
9 May 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

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.

    PubMed 34046887

  • 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.

    PubMed 34180331

  • 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.

    PubMed 34410635

  • Usmani SZ, Quach H, Mateos MV, Landgren O, Leleu X, Siegel D, Weisel K, Gavriatopoulou M, Oriol A, Rabin N, Nooka A, Qi M, Beksac M, Jakubowiak A, Ding B, Zahlten-Kumeli A, Yusuf A, Dimopoulos M. Carfilzomib, dexamethasone, and daratumumab versus carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma (CANDOR): updated outcomes from a randomised, multicentre, open-label, phase 3 study. Lancet Oncol. 2022 Jan;23(1):65-76. doi: 10.1016/S1470-2045(21)00579-9. Epub 2021 Dec 3.

    PubMed 34871550

  • Landgren O, Weisel K, Rosinol L, Touzeau C, Turgut M, Hajek R, Mollee P, Kim JS, Shu N, Hu X, Li C, Usmani SZ. Subgroup analysis based on cytogenetic risk in patients with relapsed or refractory multiple myeloma in the CANDOR study. Br J Haematol. 2022 Sep;198(6):988-993. doi: 10.1111/bjh.18233. Epub 2022 May 24.

    PubMed 35608261

  • Dimopoulos M, Quach H, Mateos MV, Landgren O, Leleu X, Siegel D, Weisel K, Yang H, Klippel Z, Zahlten-Kumeli A, Usmani SZ. 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. Lancet. 2020 Jul 18;396(10245):186-197. doi: 10.1016/S0140-6736(20)30734-0.

    PubMed 32682484

  • Leleu X, Beksac M, Chou T, Dimopoulos M, Yoon SS, Prince HM, Pour L, Shelekhova T, Chari A, Khurana M, Zhang J, Obreja M, Qi M, Oriol A, Siegel D. Efficacy and safety of weekly carfilzomib (70 mg/m2), 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. Leuk Lymphoma. 2021 Feb;62(2):358-367. doi: 10.1080/10428194.2020.1832672. Epub 2020 Oct 28.

    PubMed 33112184

  • Usmani SZ, Quach H, Mateos MV, Landgren O, Leleu X, Siegel D, Weisel K, Shu X, Li C, Dimopoulos M. Final analysis of carfilzomib, dexamethasone, and daratumumab vs carfilzomib and dexamethasone in the CANDOR study. Blood Adv. 2023 Jul 25;7(14):3739-3748. doi: 10.1182/bloodadvances.2023010026.

    PubMed 37163358

  • Weisel K, Mateos MV, Landgren O, Leleu X, Quach H, Bennett L, Talpes M, Majer I, Patel S, Usmani SZ. Health-Related Quality of Life in Patients With Relapsed/Refractory Multiple Myeloma Treated With Carfilzomib, Dexamethasone, and Daratumumab Versus Carfilzomib and Dexamethasone: An Analysis of Patient-Reported Outcomes From the Phase 3 CANDOR Trial. Clin Lymphoma Myeloma Leuk. 2025 Aug;25(8):590-605. doi: 10.1016/j.clml.2025.02.005. Epub 2025 Feb 19.

    PubMed 40087058

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dexamethasone, Daratumumab and Carfilzomib in people with Relapsed Multiple Myeloma and Refractory Multiple Myeloma, run by Amgen at 113 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 113 sites in Japan, United States, Australia, France, Romania and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03158688, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.

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