Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03158688
Other study ID # 20160275
Secondary ID 2016-003554-33
Status Completed
Phase Phase 3
First received
Last updated
Start date June 13, 2017
Est. completion date April 15, 2022

Study information

Verified date May 2024
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 466
Est. completion date April 15, 2022
Est. primary completion date July 14, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Australia Royal Adelaide Hospital Adelaide South Australia
Australia Epworth Healthcare East Melbourne Victoria
Australia St Vincents Hospital Melbourne Fitzroy, VIC Victoria
Australia Barwon Health, University Hospital Geelong Geelong Victoria
Australia Royal Brisbane and Womens Hospital Herston Queensland
Australia Liverpool Hospital Liverpool New South Wales
Australia The Alfred Hospital Melbourne Victoria
Australia St Vincents Hospital Sydney St Leonards New South Wales
Australia Westmead Hospital Westmead New South Wales
Australia Princess Alexandra Hospital Woolloongabba Queensland
Austria Medizinische Universitaet Graz Graz
Austria Landeskrankenhaus Salzburg Salzburg
Belgium Ziekenhuis Netwerk Antwerpen Stuivenberg Antwerpen
Belgium Universitair Ziekenhuis Brussel Brussel
Belgium Grand Hôpital de Charleroi Charleroi
Belgium Universitair Ziekenhuis Gent Gent
Belgium Universitair Ziekenhuis Leuven - Campus Gasthuisberg Leuven
Bulgaria University Multiprofile Hospital for Active Treatment Sveti Georgi EAD Plovdiv
Bulgaria Specialized Hospital for Active Treatment of Hematology Diseases EAD Sofia
Bulgaria University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD Sofia
Canada Tom Baker Cancer Centre Calgary Alberta
Canada Cross Cancer Institute Edmonton Alberta
Canada Hopital Maisonneuve-Rosemont Montreal Quebec
Canada Ottawa Hospital Research Institute Ottawa Ontario
Canada Princess Margaret Cancer Centre Toronto Ontario
Czechia Fakultni nemocnice Brno Brno
Czechia Fakultni nemocnice Hradec Kralove Hradec Kralove
Czechia Fakultni nemocnice Ostrava Ostrava-Poruba
Czechia Fakultni nemocnice Plzen Plzen
Czechia Vseobecna fakultni nemocnice v Praze Praha 2
France Centre Hospitalier Départemental les Oudairies La Roche Sur Yon Cedex 9
France Centre Hospitalier de Versailles - Hopital Andre Mignot Le Chesnay cedex
France Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez Lille Cedex
France Centre Hospitalier Universitaire de Nantes Nantes Cedex 1
France Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque Pessac Cedex
France Centre Hospitalier Lyon Sud Pierre-Benite cedex
France Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie Poitiers Cedex
France Centre Hospitalier Universitaire de Nancy - Hopital de Brabois Vandoeuvre les Nancy Cedex
Greece Alexandra Hospital Athens
Greece General Hospital Evangelismos Athens
Greece General University Hospital of Patras Panagia i Voithia Patra
Greece Theagenion Cancer Hospital of Thessaloniki Thessaloniki
Hungary Bekes Megyei Kozponti Korhaz Dr Rethy Pal Tagkorhaz Bekescsaba
Hungary Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet Budapest
Hungary Semmelweis Egyetem Budapest
Hungary Debreceni Egyetem Klinikai Kozpont Debrecen
Hungary Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar Szeged
Japan Kyushu University Hospital Fukuoka-shi Fukuoka
Japan National Hospital Organization Kyushu Cancer Center Fukuoka-shi Fukuoka
Japan Tesshokai Kameda General Hospital Kamogawa-shi Chiba
Japan Saitama Medical Center Kawagoe-shi Saitama
Japan Cancer Institute Hospital of Japanese Foundation for Cancer Research Koto-ku Tokyo
Japan University Hospital Kyoto Prefectural University of Medicine Kyoto-shi Kyoto
Japan Gunma University Hospital Maebashi-shi Gunma
Japan Nagoya City University Hospital Nagoya-shi Aichi
Japan Niigata Cancer Center Hospital Niigata-shi Niigata
Japan Ogaki Municipal Hospital Ogaki-shi Gifu
Japan National Hospital Organization Okayama Medical Center Okayama-shi Okayama
Japan National Hospital Organization Shibukawa Medical Center Shibukawa-shi Gunma
Japan Japanese Red Cross Medical Center Shibuya-ku Tokyo
Japan Osaka University Hospital Suita-shi Osaka
Japan Tokushima Prefectural Central Hospital Tokushima-shi Tokushima
Japan Toyohashi Municipal Hospital Toyohashi-shi Aichi
Japan Tochigi Cancer Center Utsunomiya-shi Tochigi
Korea, Republic of National Cancer Center Goyang-si, Gyeonggi-do
Korea, Republic of Chonnam National University Hwasun Hospital Hwasun, Jeollanam-do
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital Yonsei University Health System Seoul
Korea, Republic of The Catholic University of Korea Seoul St Marys Hospital Seoul
Poland InterHem Bialystok
Poland Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich w Chorzowie Chorzow
Poland Centrum Onkologii Ziemi Lubelskiej im Swietego Jana z Dukli Lublin
Poland Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K Marcinkowskiego w Poznaniu Poznan
Poland Instytut Hematologii i Transfuzjologii Warszawa
Poland Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wroclawiu Wroclaw
Romania Policlinica de Diagnostic Rapid Brasov
Romania Coltea Clinical Hospital Bucharest
Romania Fundeni Clinical Institute Bucharest
Romania Bucharest Emergency University Hospital Bucuresti
Romania Spitalul Clinic Colentina Bucuresti
Romania Profesor Dr Ion Chiricuta Institut of Oncology Cluj-Napoca
Romania Spitalul Clinic Municipal Filantropia Craiova Craiova
Russian Federation SBHI of Nizhny Novgorod region Regional Clinical Hospital of Nizhny Novgorod na N A Semashko Nizhny Novgorod
Russian Federation SBHI of Republic of Karelia Republic Hosiptal n a V A Baranov Petrozavodsk
Russian Federation State Budget Educational Institution of High Professional Skills Samara State Medical University Samara
Russian Federation Clinic of professional pathology and hematology Saratov
Spain Hospital Universitari Germans Trias i Pujol Badalona Cataluña
Spain Hospital Clinic i Provincial de Barcelona Barcelona Cataluña
Spain Hospital Universitario 12 de Octubre Madrid
Spain Clinica Universidad de Navarra Pamplona Navarra
Spain Hospital Clinico Universitario de Salamanca Salamanca Castilla León
Taiwan National Taiwan University Hospital Taipei
Taiwan Taipei Veterans General Hospital Taipei
Turkey Ankara Universitesi Tip Fakultesi Cebeci Hastanesi Ankara
Turkey Hacettepe Universitesi Tip Fakultesi Ankara
Turkey Ege University Faculty of Medicine Izmir
Turkey Ondokuz Mayis Universitesi Tip Fakultesi Samsun
United Kingdom St James University Hospital Leeds
United Kingdom University College London Hospital London
United Kingdom Christie Hospital Manchester
United States Emory University Winship Cancer Institute Atlanta Georgia
United States Lynn Cancer Center Boca Raton Regional Hospital, Lynn Cancer Institute Boca Raton Florida
United States Charleston Oncology Charleston South Carolina
United States Levine Cancer Institute Charlotte North Carolina
United States University of Chicago Medical Center - Multiple Myeloma Research Consortium Chicago Illinois
United States Baylor Charles A Sammons Cancer Center at Dallas Dallas Texas
United States Gabrail Cancer Center, LLC Dover Ohio
United States Fort Wayne Medical Oncology and Hematology Fort Wayne Indiana
United States Hackensack University Medical Center Hackensack New Jersey
United States Hattiesburg Clinic Hematology/Oncology Hattiesburg Mississippi
United States New York Presbyterian Hospital, Weill Cornell Medical College New York New York

Sponsors (1)

Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Bulgaria,  Canada,  Czechia,  France,  Greece,  Hungary,  Japan,  Korea, Republic of,  Poland,  Romania,  Russian Federation,  Spain,  Taiwan,  Turkey,  United Kingdom, 

References & Publications (8)

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. Erratum In: Lancet. 2020 Aug 15;396(10249):466. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks
Secondary 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.
From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks
Secondary 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). 12 Months (8- to 13-month window)
Secondary 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. 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)
Secondary 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.
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
Secondary 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.
From Day 1 until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks
Secondary 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.
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
Secondary 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. From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks
Secondary 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.
Randomization to Months 3, 6, 12, and 18
Secondary 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. From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks
Secondary 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.
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
Secondary 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. From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks
Secondary 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.
12 Months (8- to 13-month window)
Secondary 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).
Baseline (Day 1 pre-dose) up to 236.3 weeks (longest treatment duration as of the FA DCO)
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04083534 - First In Human (FIH) Study of REGN5459 in Adult Patients With Relapsed or Refractory Multiple Myeloma (MM) Phase 1/Phase 2
Completed NCT01775553 - Study of High Dose Carfilzomib in Multiple Myeloma Patients Who Have Progressed On Standard Dose Carfilzomib Phase 2
Terminated NCT02020941 - Carfilzomib in Treating Patients With Multiple Myeloma in First Relapse or Refractory to First-Line Therapy Phase 2
Completed NCT01212952 - Pomalidomide, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma Phase 1/Phase 2
Terminated NCT01078441 - Bortezomib, Liposomal Doxorubicin Hydrochloride, Dexamethasone, and Cyclophosphamide in Treating Patients With Multiple Myeloma That Relapsed After Autologous Stem Cell Transplant Phase 2
Completed NCT01233921 - Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer N/A
Completed NCT00514137 - Sunitinib in Treating Patients With Relapsed Multiple Myeloma Phase 2
Completed NCT00306813 - Evaluation of Lenalidomide, Doxorubicin and Dexamethasone (RAD) in Patients With Relapsed or Refractory Multiple Myeloma Phase 1/Phase 2
Completed NCT00078858 - Mycophenolate Mofetil and Cyclosporine in Reducing Graft-Versus-Host Disease in Patients With Hematologic Malignancies or Metastatic Kidney Cancer Undergoing Donor Stem Cell Transplant Phase 1/Phase 2
Completed NCT00047203 - Flavopiridol in Treating Patients With Relapsed or Refractory Multiple Myeloma Phase 2
Active, not recruiting NCT03731832 - Pomalidomide, Ixazomib, and Dexamethasone With or Without Intensification by Cyclophosphamide in Relapsed or Refractory Multiple Myeloma Phase 2
Completed NCT00003196 - Low-Dose Total Body Irradiation and Donor Peripheral Blood Stem Cell Transplant Followed by Donor Lymphocyte Infusion in Treating Patients With Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma N/A
Recruiting NCT03601624 - Pomalidomide/Cyclophosphamide/Dexamethasone in Relapse Refractory Myeloma: Safety Profile in Mexicans Phase 2
Terminated NCT01954784 - Lenalidomide After Donor Stem Cell Transplant and Bortezomib in Treating Patients With High Risk Multiple Myeloma Phase 1
Recruiting NCT05020444 - TriPRIL CAR T Cells in Multiple Myeloma Phase 1
Completed NCT01588015 - Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant Phase 1
Recruiting NCT04302324 - A Phase II Study of Daratumumab, Clarithromycin, Pomalidomide And Dexamethasone (D-ClaPd) In Multiple Myeloma Patients Previously Exposed to Daratumumab Phase 2
Recruiting NCT06119685 - IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers Phase 1/Phase 2
Completed NCT00118170 - Sorafenib in Treating Patients With Metastatic or Unresectable Solid Tumors, Multiple Myeloma, or Non-Hodgkin's Lymphoma With or Without Impaired Liver or Kidney Function Phase 1
Completed NCT00054353 - Reduced-Intensity Conditioning Followed By Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Multiple Myeloma Phase 1/Phase 2