Study of Carfilzomib, Daratumumab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma. (CANDOR)
Relapsed Multiple Myeloma, Refractory Multiple Myeloma
About this trial
This is an interventional treatment trial for Relapsed Multiple Myeloma focused on measuring Carfilzomib, Dexamethasone, Daratumumab
Eligibility 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
Sites / Locations
- Lynn Cancer Center Boca Raton Regional Hospital, Lynn Cancer Institute
- Emory University Winship Cancer Institute
- University of Chicago Medical Center - Multiple Myeloma Research Consortium
- Fort Wayne Medical Oncology and Hematology
- Hattiesburg Clinic Hematology/Oncology
- Hackensack University Medical Center
- New York Presbyterian Hospital, Weill Cornell Medical College
- Levine Cancer Institute
- Gabrail Cancer Center, LLC
- Charleston Oncology
- Baylor Charles A Sammons Cancer Center at Dallas
- Liverpool Hospital
- St Vincents Hospital Sydney
- Westmead Hospital
- Royal Brisbane and Womens Hospital
- Princess Alexandra Hospital
- Royal Adelaide Hospital
- Epworth Healthcare
- St Vincents Hospital Melbourne
- Barwon Health, University Hospital Geelong
- The Alfred Hospital
- Medizinische Universitaet Graz
- Landeskrankenhaus Salzburg
- Ziekenhuis Netwerk Antwerpen Stuivenberg
- Universitair Ziekenhuis Brussel
- Grand Hôpital de Charleroi
- Universitair Ziekenhuis Gent
- Universitair Ziekenhuis Leuven - Campus Gasthuisberg
- University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
- University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD
- Specialized Hospital for Active Treatment of Hematology Diseases EAD
- Tom Baker Cancer Centre
- Cross Cancer Institute
- Ottawa Hospital Research Institute
- Princess Margaret Cancer Centre
- Hopital Maisonneuve-Rosemont
- Fakultni nemocnice Brno
- Fakultni nemocnice Hradec Kralove
- Fakultni nemocnice Ostrava
- Fakultni nemocnice Plzen
- Vseobecna fakultni nemocnice v Praze
- Centre Hospitalier Départemental les Oudairies
- Centre Hospitalier de Versailles - Hopital Andre Mignot
- Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez
- Centre Hospitalier Universitaire de Nantes
- Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque
- Centre Hospitalier Lyon Sud
- Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie
- Centre Hospitalier Universitaire de Nancy - Hopital de Brabois
- General Hospital Evangelismos
- Alexandra Hospital
- General University Hospital of Patras Panagia i Voithia
- Theagenion Cancer Hospital of Thessaloniki
- Bekes Megyei Kozponti Korhaz Dr Rethy Pal Tagkorhaz
- Semmelweis Egyetem
- Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
- Debreceni Egyetem Klinikai Kozpont
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar
- Nagoya City University Hospital
- Toyohashi Municipal Hospital
- Tesshokai Kameda General Hospital
- National Hospital Organization Kyushu Cancer Center
- Kyushu University Hospital
- Ogaki Municipal Hospital
- Gunma University Hospital
- National Hospital Organization Shibukawa Medical Center
- University Hospital Kyoto Prefectural University of Medicine
- Niigata Cancer Center Hospital
- National Hospital Organization Okayama Medical Center
- Osaka University Hospital
- Saitama Medical Center
- Tochigi Cancer Center
- Tokushima Prefectural Central Hospital
- Cancer Institute Hospital of Japanese Foundation for Cancer Research
- Japanese Red Cross Medical Center
- National Cancer Center
- Chonnam National University Hwasun Hospital
- Seoul National University Hospital
- Severance Hospital Yonsei University Health System
- Asan Medical Center
- Samsung Medical Center
- The Catholic University of Korea Seoul St Marys Hospital
- InterHem
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich w Chorzowie
- Centrum Onkologii Ziemi Lubelskiej im Swietego Jana z Dukli
- Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K Marcinkowskiego w Poznaniu
- Instytut Hematologii i Transfuzjologii
- Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wroclawiu
- Policlinica de Diagnostic Rapid
- Fundeni Clinical Institute
- Coltea Clinical Hospital
- Spitalul Clinic Colentina
- Bucharest Emergency University Hospital
- Profesor Dr Ion Chiricuta Institut of Oncology
- Spitalul Clinic Municipal Filantropia Craiova
- SBHI of Nizhny Novgorod region Regional Clinical Hospital of Nizhny Novgorod na N A Semashko
- SBHI of Republic of Karelia Republic Hosiptal n a V A Baranov
- State Budget Educational Institution of High Professional Skills Samara State Medical University
- Clinic of professional pathology and hematology
- Hospital Clinico Universitario de Salamanca
- Hospital Universitari Germans Trias i Pujol
- Hospital Clinic i Provincial de Barcelona
- Clinica Universidad de Navarra
- Hospital Universitario 12 de Octubre
- National Taiwan University Hospital
- Taipei Veterans General Hospital
- Hacettepe Universitesi Tip Fakultesi
- Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
- Ege University Faculty of Medicine
- Ondokuz Mayis Universitesi Tip Fakultesi
- St James University Hospital
- University College London Hospital
- Christie Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Kd - Carfilzomib and Dexamethasone
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.
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.