A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
- Evidence of a response (Partial response [PR] or better based on investigator's determination of response by international myeloma working group [IMWG] criteria) to at least 1 prior treatment regimen
- Received at least 3 prior lines of therapy including a proteasome inhibitor (PI) (greater than or equal to [>=] 2 cycles or 2 months of treatment) and an immunomodulatory drug (IMiD) (>=2 cycles or 2 months of treatment) in any order during the course of treatment (except for participants who discontinued either of these treatments due to a severe allergic reaction within the first 2 cycles/months). A single line of therapy may consist of 1 or more agents, and may include induction, hematopoietic stem cell transplantation, and maintenance therapy. Radiotherapy, bisphosphonate, or a single short course of corticosteroids (no more than the equivalent of dexamethasone 40 milligram/day [mg/day] for 4 days) would not be considered prior lines of therapy
Documented multiple myeloma as defined by the criteria below:
- Multiple myeloma diagnosis according to the IMWG diagnostic criteria
Measurable disease at Screening as defined by any of the following:
- Serum M-protein level >=1.0 gram per deciliter (g/dL) or urine M-protein level >=200 mg/24 hours; or
- Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain (FLC) >=10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- Meet the clinical laboratory criteria as specified in the protocol
- Women of childbearing potential must have a negative urine or serum pregnancy test at screening within 14 days prior to randomization
Exclusion Criteria:
- Received daratumumab or other anti-CD38 therapies previously
- Received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of randomization. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 mg/day for a maximum of 4 days) before treatment
- Received autologous stem cell transplant within 12 weeks before the date of randomization, or the participant has previously received allogeneic stem cell transplant (regardless of timing)
- Plans to undergo a stem cell transplant prior to progression of disease on this study (these participants should not be enrolled to reduce disease burden prior to transplant)
- History of malignancy (other than multiple myeloma) unless all treatment of that malignancy was completed at least 2 years before consent and the patient has no evidence of disease. Further exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion, that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years
Sites / Locations
- Dana-Farber Cancer Institute
- Levine Cancer Institute
- Royal Prince Alfred Hospital
- St. Vincent's Hospital Melbourne
- Alfred Health
- Fiona Stanley Hospital
- Sir Charles Gairdner Hospital
- Calvary Mater Newcastle Hospital
- The Queen Elizabeth Hospital
- Princess Alexandra Hospital
- Fundacao Pio XII
- Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN
- Fundacao Doutor Amaral Carvalho
- Instituto Joinvilense de Hematologia e Oncologia Ltda-Centro de Hematologia e Oncologia
- Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo
- Hospital das Clinicas de Porto Alegre
- Instituto de Educacao, Pesquisa e Gestao em Saude
- CEHON
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base
- Clinica Sao Germano
- Hospital Das Clinicas Da Faculdade De Medicina Da USP
- Tom Baker Cancer Centre
- Cross Cancer Institute
- The Gordon & Leslie Diamond Health Care Center
- QEII Health Sciences Centre
- Victoria Hospital
- Princess Margaret Hospital
- CHU de Québec -L'Hôtel-Dieu de Québec
- Fakultni nemocnice Brno
- Fakultni nemocnice Hradec Kralove
- Fakultní nemocnice Olomouc
- Fakultni nemocnice Ostrava
- Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni
- Fakultni nemocnice Kralovske Vinohrady
- Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie
- CHU Caen - Côte de Nacre
- Hopital Claude Huriez
- CHU de Nantes hotel-Dieu
- CHU de Boreaux
- Centre hospitalier Lyon-Sud
- CHU Poitiers - Hôpital la Milétrie
- CHU Nancy Brabois
- Alexandra General Hospital of Athens
- Hillel Yaffe Medical Center - Oncology
- Rambam Med.Center - Hematology Institute
- Carmel Medical Center
- Hadassah Medical Center
- Rabin Medical Center, Beilinson Campus
- Sheba Medical Center Tel Hashomer
- Tel Aviv Sourasky Medical Center
- Policlinico Sant'Orsola Malpighi
- Fondazione IRCCS Istituto Nazionale dei Tumori
- Ospedale Villa Sofia-Cervello
- Fondazione IRCCS Policlinico San Matteo
- Azienda USL di Piacenza
- Università di Roma La Sapienza
- Policlinico Universitario Agostino Gemelli
- A.O.U. Città della Salute e della Scienza
- Fukuoka University Hospital
- Chugoku Central Hospital
- Ogaki Municipal Hospital
- Gunma University Hospital
- Kobe City Medical Center General Hospital
- Iwate Medical University Hospital
- University Hospital Kyoto Perfectural University of Medicine
- Matsuyama Red Cross Hospital
- Japanese Red Cross Nagoya Daini Hospital
- Nagoya City University Hospital
- Niigata Cancer Center Hospital
- National Hospital Organization Okayama Medical Center
- Osaka University Hospital
- National Hospital Organization Sendai Medical Center
- National Hospital Organization Shibukawa Medical Center
- Japanese Red Cross Medical Center
- Pusan National University Hospital
- National Cancer Center
- Gachon University Gil Medical Center
- Severance Hospital
- Asan Medical Center
- Samsung Medical Center
- The Catholic University of Korea Seoul St. Mary's Hospital
- Ulsan University Hospital
- Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza
- Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
- Szpitale Pomorskie Sp. z o.o.
- Szpital Uniwersytecki w Krakowie
- Wojewodzki Szpital Specjalistyczny w Legnicy
- Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
- Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
- Emergency Hospital of Dzerzhinsk
- Ekaterinburg City Clinical Hospital # 7
- S.P. Botkin Moscow City Clinical Hospital
- City Clinical Hospital # 40
- Nizhniy Novgorod Region Clinical Hospital
- Penza Regional Oncology Dispensary
- Ryazan Regional Clinical Hospital
- Saint Petersburg City Hospital #15
- Samara Region Clinical Hospital
- Clinical Research Institute of Hematology and Transfusiology
- Oncology Dispensary of Komi Republic
- Hosp. Univ. Germans Trias I Pujol
- Hosp. Clinic I Provincial de Barcelona
- Hosp. Univ. Dr. Josep Trueta
- Hosp. Univ. Virgen de Las Nieves
- Hosp. Univ. de Canarias
- Hosp. de Leon
- Hosp. Gral. Univ. Gregorio Maranon
- Hosp. Univ. Infanta Leonor
- Hosp. Univ. 12 de Octubre
- Clinica Univ. de Navarra
- Hosp. Quiron Madrid Pozuelo
- Hosp. Clinico Univ. de Salamanca
- Hosp. Univ. Dr. Peset
- Falu Lasarett
- Helsingborgs lasarett
- Karolinska University Hospital, Huddinge
- Skanes universitetssjukhus
- Norrlands University Hospital
- Akademiska Sjukhuset
- Chang-Hua Christian Hospital
- China Medical University Hospital
- Taichung Veterans General Hospital
- National Cheng Kung University Hospital
- National Taiwan University Hospital
- Chang Gung Memorial Hospital
- Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'
- Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center
- Ivano-Frankivsk Regional Clinical Hospital
- SI Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine
- National Cancer Institute, Dept. of chemotherapy of hemoblastosis
- Kiev Marrow Transplantation Center, Bone Marrow Transplantation Department
- State Institution 'National Scientific Center for Radiation Medicine of NAMS of Ukraine'
- Institute of Blood Pathology and Transfusion Medicine of AMS of Ukraine
- Mykolaiv Regional Clinical Hospital
- Ukrainian Medical Stomatological Academy, Poltava Regional Clinical Hospital
- Blackpool Victoria Hospital
- Royal Bournemouth Hospital
- Leicester Royal Infirmary - Haematology
- St Bartholomew's Hospital
- Guy's & St Thomas Hospital
- Christie Hospital NHS Trust
- Nottingham City Hospital
- Royal Marsden Hospital
- New Cross Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Dara SC
Dara IV
Participants will receive a fixed dose of daratumumab as 1800 milligram (mg) subcutaneously (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Unit per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The duration for each cycle is 4 weeks.
Participants will receive daratumumab for intravenous infusion (Dara IV) 16 mg/kg once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks on Day 1 in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The duration for each cycle is 4 weeks. For Participants still receiving treatment with Dara-IV at the time of Protocol Amendment 4 the duration of infusion may be shortened to a 90-minute infusion or participants will have the option to switch to Dara 1800 mg subcutaneous (SC) on Day 1 of any cycle, at the discretion of the investigator.