- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03871829
Daratumumab Retreatment in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab
November 29, 2023 updated by: Janssen Research & Development, LLC
A Phase 2 Study of Daratumumab Subcutaneous (Dara-SC) Administration in Combination With Carfilzomib and Dexamethasone (DKd) Compared With Carfilzomib and Dexamethasone (Kd) in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab to Evaluate Daratumumab Retreatment
The purpose of this study is to compare the efficacy (rate of very good partial response [VGPR] or better as best response as defined by the International Myeloma Working Group [IMWG] criteria) of daratumumab subcutaneous (Dara-SC) in combination with carfilzomib and dexamethasone (Kd) with the efficacy of Kd in participants with relapsed refractory multiple myeloma who were previously exposed to daratumumab to evaluate daratumumab retreatment.
Study Overview
Status
Terminated
Conditions
Detailed Description
For relapsed or refractory multiple myeloma, the treatment is determined on an individual basis.
Common standard of care regimens use either a proteasome inhibitor (PI) or an immunomodulatory agent (IMiD) in combination with dexamethasone with or without a monoclonal antibody (mAb) such as daratumumab.
After relapse from PIs or IMiDs, patients are often retreated with drugs that have same mechanism of action to which they have been sensitive.
The disease becomes refractory and all effective treatment options are exhausted.
Daratumumab is a human IgG1 mAb that binds with high affinity to unique epitope on cluster of differentiation 38 (CD38) and attacks tumor cells that overexpress CD38.
Study is to determine the efficacy of Dara-SC in combination with carfilzomib and dexamethasone (DKd) in adult participants with relapsed refractory MM who had 1 to 3 prior line(s) of treatment including a line containing daratumumab to evaluate daratumumab retreatment.
The MM treatment is determined on an individual basis where patient's age, prior therapy, bone marrow function, co-morbidities, patient preference and time to relapse are considered.
Common standard of care regimens use either PI or an IMiD in combination with dexamethasone with or without a mAb.
It is a targeted immunotherapy that attacks tumor cells that overexpress CD38, a transmembrane glycoprotein, in a variety of hematological malignancies including multiple myeloma.
The study will be conducted in 3 phases: Screening (28 days), Treatment, and Follow-Up.
Assessments like chest X-ray, spirometry test, electrocardiogram (ECG), will be performed during Screening phase.
During the Treatment Phase, participants will be randomized to receive Kd or DKd.
Efficacy assessments like bone marrow examination will be performed.
Follow-up will continue until the end of study.
Study Type
Interventional
Enrollment (Actual)
88
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Antwerpen, Belgium, 2060
- ZNA Stuivenberg
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Gent, Belgium, 9000
- UZ Gent
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Campinas, Brazil, 13083-878
- Universidade Estadual de Campinas
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Curitiba, Brazil, 81520-060
- Liga Paranaense de Combate ao Cancer
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Goiania, Brazil, 74605-020
- Universidade Federal de Goias - Hospital das Clinicas da UFG
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Natal, Brazil, 59062-000
- Liga Norte Riograndense Contra O Câncer
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Porto Alegre, Brazil, 90050-170
- Irmandade Santa Casa de Misericordia de Porto Alegre
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Rio de Janeiro, Brazil, 20230-130
- Ministerio da Saude - Instituto Nacional do Cancer
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Rio de Janeiro, Brazil, 22775-001
- Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
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Salvador, Brazil, 45995-000
- CEHON
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Salvador, Brazil, 41253-190
- Hospital Sao Rafael
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Sao Paulo, Brazil, 01509900
- Fundacao Antonio Prudente - A.C. Camargo Cancer Center
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Sao Paulo, Brazil, 01236-030
- Instituto de Ensino E Pesquisa Sao Lucas
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Sao Paulo, Brazil, 03102-002
- Instituto Brasileiro de Controle do Cancer - Sao Camilo Oncologia
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São Paulo, Brazil, 01321-001
- Real e Benemérita Associação Portuguesa de Beneficência
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São Paulo, Brazil, 01455-010
- Clinica Sao Germano
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Centre
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Aarhus N, Denmark, DK-8200
- Aarhus University Hospital
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Holstebro, Denmark, 7500
- Regionshospitalet i Holstebro
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Odense, Denmark, 5000
- Haematological Research unit HFE-X OUH.
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Vejle, Denmark, DK-7100
- Vejle Hospital
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Lille, France, 59037
- Hôpital Claude Huriez
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Montpellier, France, 34295
- CHU de Montpellier, Hopital Saint-Eloi
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Mulhouse, France, 68100
- Centre Hospitalier Emile Muller
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Nantes, France, 44035
- Hotel Dieu
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Paris, France, 75743
- Hôpital Necker-Enfants Malades
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Paris, France, 75013
- Hopital de la Pitie Salpetriere
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Paris, France, 75012
- Hopitaux Universitaires Est Parisien Hopital Saint Antoine
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Pessac, France, 33600
- Fentre F Magendie, Hôpital Haut Leveque, CHU Bordeaux
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Pierre Benite, France, 69310
- Centre Hospitalier Lyon-Sud Service d'hematologie
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Poitiers, France, 86021
- CHU Poitiers - Hôpital la Milétrie
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Rennes Cedex, France, 35033
- CHU Rennes - Hopital Pontchaillou
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Toulouse, France, 31052
- Institut Claudius Regaud
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Tours, France, 37044
- CHU Bretonneau
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Vandoeuvre Les Nancy, France, 54511
- CHU Nancy Brabois
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Dresden, Germany, 1307
- Universitätsklinik Carl Gustav Carus, Med. Klinik u. Poliklinik I
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Essen, Germany, D-45147
- Universitätsklinikum Essen
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Essen, Germany, 45239
- Evangelisches Krankenhaus Essen-Werden
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Hamburg, Germany, 20246
- Universitätsklinik Hamburg-Eppendorf UKE
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Hamm, Germany, 59075
- St. Barbara-Klinik Hamm GmbH
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Koblenz, Germany, 56068
- Praxisklinik für Haematologie und Onkologie Koblenz
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Koeln, Germany, 50397
- Universitaetsklinikum Koelnt
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Mainz, Germany, 55101
- Universitätsmedizin der Johannes gutenberg-Universität; III. Med. Klinik - Germany
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Saarbrucken, Germany
- Onkologische Schwerpunkt Praxis
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Tubingen, Germany, 72076
- Klinikum der Eberhard-Karls-Universität/Abt. für innere Med. II/Hämatologie/Onkologie-Germany
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Villingen-Schwenningen, Germany, 78052
- Schwarzwald-Baar Klinikum
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Würzburg, Germany, 97080
- Universitätsklinikum Würzburg Med. Klinik U. Poliklinik Ii
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Athens, Greece, 106 76
- University of Athens - Evaggelismos Hospital (Evangelismos Hospital)
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Athens Attica, Greece, 115 28
- Alexandra General Hospital of Athens
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Larisa, Greece, 41110
- University Hospital of Larissa
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Patra, Greece, 26500
- University General Hospital of Rio
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Thessaloniki, Greece, 546 39
- Anticancer Hospital of Thessaloniki 'Theageneio'
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Bergamo, Italy, 24127
- Azienda Ospedaliera Papa Giovanni XXIII
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Bologna, Italy, 40138
- Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi
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Firenze, Italy, 50139
- Azienda Ospedaliera Universitaria Careggi
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Genova, Italy, 16132
- IRCCS Azienda Ospedaliera San Martino - IST
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Genova, Italy, 16132
- San Martino Hospital
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Legnano, Italy, 20025
- ASST OVEST Milanese - Ospedale di Legnano
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Meldola, Italy, 47014
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
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Milano, Italy, 20162
- ASST Grande Ospedale Metropolitano Niguarda
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Novara, Italy, 28100
- Ospedale Maggiore della Carità
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Palermo, Italy, 90146
- Casa di Cura La Maddalena
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Palermo, Italy, 90146
- Ospedale Villa Sofia-Cervello
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Pavia, Italy, 27100
- Fondazione IRCCS Policlinico San Matteo
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Roma, Italy, 00168
- Fondazione Policlinico Universitario A. Gemelli IRCCS
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Roma, Italy, 00133
- Universita Degli Studi di Roma 'Tor Vergata'
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Roma, Italy, 00161
- Sapienza University of Rome
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Roma, Italy, 30 - 00153
- ASL ROMA
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San Giovanni Rotondo, Italy, 71013
- IRCCS Ospedale Casa Sollievo della Sofferenza
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Terni, Italy, 5100
- Azienda Ospedaliera Santa Maria
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Dordrecht, Netherlands, 3318 AT
- Albert Schweitzer ziekenhuis-lokatie Dordwijk
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Sittard, Netherlands, 6130 MB
- Zuyderland Medical Center
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Bydgoszcz, Poland, 85-168
- Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy
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Opole, Poland, 45-061
- Szpital Wojewodzki w Opolu
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Warszawa, Poland, 01-748
- Szpital Magodent
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Wroclaw, Poland, 52-007
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
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Dzerzhinsk, Russian Federation, 606019
- Emergency Hospital of Dzerzhinsk
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Moscow, Russian Federation, 125284
- S.P. Botkin Moscow City Clinical Hospital
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Nizhny Novgorod, Russian Federation, 603126
- Nizhniy Novgorod Region Clinical Hospital
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Ryazan, Russian Federation, 390003
- Ryazan Regional Clinical Hospital
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Sochi, Russian Federation, 354057
- Oncological dispensary #2
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St-Petersburg, Russian Federation, 191024
- Clinical Research Institute of Hematology and Transfusiology
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Syktyvkar, Russian Federation, 167904
- Oncology Dispensary of Komi Republic
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Barcelona, Spain, 08036
- Hosp. Clinic I Provincial de Barcelona
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Barcelona, Spain, 08908
- Inst. Cat. Doncologia-H Duran I Reynals
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Jerez de la Frontera, Spain, 11407
- Hosp. de Jerez de La Frontera
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Leon, Spain, 24008
- Hosp. de Leon
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Madrid, Spain, 28041
- Hosp. Univ. 12 de Octubre
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Madrid, Spain, 28034
- Hosp. Univ. Ramon Y Cajal
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Madrid, Spain, 28046
- Hosp. Univ. de La Paz
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Malaga, Spain, 29603
- Hosp. Costa Del Sol
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Palma, Spain, 7120
- Hosp. Univ. Son Espases
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Pamplona, Spain, 31008
- Clinica Univ. de Navarra
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Salamanca, Spain, 37007
- Hosp. Clinico Univ. de Salamanca
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San Cristóbal de La Laguna, Spain, 38320
- Hosp. Univ. de Canarias
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Sevilla, Spain, 41013
- Hosp. Virgen Del Rocio
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Toledo, Spain, 45007
- Hosp. Gral. Univ. de Toledo
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Arizona
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Gilbert, Arizona, United States, 85234
- Banner MD Anderson Cancer Center
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Tucson, Arizona, United States, 85745
- Oncology Institute of Hope and Innovation
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California
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Whittier, California, United States, 90603
- American Institute of Research (AIR)
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Indiana
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Fort Wayne, Indiana, United States, 46804
- Fort Wayne Medical Oncology and Hematology, Inc.
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Michigan
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Detroit, Michigan, United States, 48201
- Karmanos Cancer Institute - Wayne State University
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic - Rochester
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Missouri
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Saint Louis, Missouri, United States, 63110-1032
- Washington University School of Medicine
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New York
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New York, New York, United States, 10065
- Weill Medical College of Cornell University
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Main Campus
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Texas
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Dallas, Texas, United States, 75246
- Baylor Scott and White Health
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Houston, Texas, United States, 77090
- Millennium Oncology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Evidence of a response (partial response or better based on investigator's determination of response by International Myeloma Working Group [IMWG] criteria) to daratumumab-containing therapy with response duration of at least 4 months
- Participants must have progressed from or be refractory to their last line of treatment. Relapsed or refractory disease as defined as: a) Relapsed disease is defined as an initial response to previous treatment, followed by confirmed progressive disease (PD) by IMWG criteria greater than (>) 60 days after cessation of treatment. b) Refractory disease is defined as less than (<) 25 percent (%) reduction in M-protein or confirmed PD by IMWG criteria during previous treatment or >60 days after cessation of treatment
- Received 1 to 3 prior line(s) of treatment of which one contained daratumumab, and completed daratumumab at least 3 months prior to randomization. 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 per day [mg/day] for 4 days) would not be considered prior lines of therapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
- Women of childbearing potential must have a negative urine or serum pregnancy test at screening within 14 days prior to randomization
Exclusion Criteria:
- Previous treatment with daratumumab within the last 3 months prior to randomization
- Discontinuation of daratumumab due to a daratumumab-related adverse event (AE)
- 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
- Allergies, hypersensitivity, or intolerance to daratumumab, hyaluronidase, monoclonal antibodies (mAbs), human proteins, or their excipients, or known sensitivity to mammalian-derived products. Known history of allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib)
- Participant is: a) Known to be seropositive for human immunodeficiency virus (HIV) with one or more of the following: not receiving highly active antiretroviral therapy (ART), had a change in ART within 6 months of the start of screening, receiving ART that may interfere with study treatment, cluster of differentiation (CD)4 count <350 (unit: cells per cubic millimeter of blood) at screening, acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 6 months of start of screening, and not agreeing to start ART and be on ART >4 weeks plus having HIV viral load <400 copies/milliliters (mL) at end of 4-week period (to ensure ART is tolerated and HIV controlled. b) Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Participants with resolved infection (example: participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded. c) Known to be seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Arm A: Carfilzomib+Dexamethasone (Kd)
Participants will receive carfilzomib 20 milligram per square meter (mg/m^2) intravenously (IV) on Day 1 of Cycle 1 and then 70 mg/m^2 on Days 8 and 15 of Cycle 1 and thereafter on Days 1, 8, 15 of Cycle 2 onwards.
Participants will receive dexamethasone 20 mg on Cycle 1 Day 1, a second dose of 20 milligram (mg) will be given on Cycle 1 Day 2 and 40 mg IV or orally on Days 8, 15, 22 for Cycle 1. Patients will then receive dexamethasone 40mg on days 1, 8, 15 and 22 for cycles 2-9, then on Days 1, 8, 15 for Cycle 10 onwards, until death, intolerable toxicity, start of a new treatment for multiple myeloma, withdrawal of consent, or end of the study.
The total duration of each cycle is 28 Days.
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Carfilzomib 20 mg/m^2 will be administered intravenously (IV).
Carfilzomib 70 mg/m^2 will be administered IV.
Dexamethasone 40 mg will be administered as IV infusion or orally.
Dexamethasone 20 mg will be administered as IV infusion or orally.
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Experimental: Arm B: Dara-SC in combination with Kd (DKd)
Participants will receive daratumumab subcutaneous (Dara-SC) 1800 mg by SC injection on Days 1, 8, 15, 22 for Cycle 1 and 2, Days 1 and 15 for Cycle 3-6, Day 1 for Cycle 7 onwards.
Participants will receive carfilzomib 20 mg/m^2 IV on Cycle 1 Day 1 and then 70 mg/m^2 on Day 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2. Participants will receive dexamethasone 20 mg on Cycle 1 Day 1, a second dose of 20 milligram (mg) will be given on Cycle 1 Day 2 and 40 mg IV or orally on Days 8, 15, 22 for Cycle 1. Patients will then receive dexamethasone 40mg on days 1, 8, 15 and 22 for cycles 2-9, then on Days 1, 8, 15 for Cycle 10 onwards, until death, intolerable toxicity, start of a new treatment for multiple myeloma, withdrawal of consent, or end of the study.
The total duration of each cycle is 28 Days.
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Carfilzomib 20 mg/m^2 will be administered intravenously (IV).
Carfilzomib 70 mg/m^2 will be administered IV.
Dexamethasone 40 mg will be administered as IV infusion or orally.
Dexamethasone 20 mg will be administered as IV infusion or orally.
Dara-SC 1800 mg will be administered by SC injection.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants Achieving Very Good Partial Response (VGPR) or Better Response
Time Frame: Up to 3 years and 4 months
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Percentage of participants achieving VGPR or better response were reported.
VGPR or better rate was defined as the percentage of participants achieving VGPR, complete response (CR), or stringent complete response (sCR) in accordance with the International Myeloma Working Group (IMWG) criteria, during or after the study treatment but before the start of subsequent anti-myeloma therapy.
IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or greater than or equal to (>=) 90 percent (%) reduction in serum M-protein plus urine M-protein less than (<) 100 milligram (mg)/24 hours; for CR: Negative immunofixation on the serum and urine, and Disappearance of any soft tissue plasmacytomas (PCs), and <5% PCs in bone marrow; for sCR: CR plus normal free light chain (FLC) ratio, and Absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4- color flow cytometry.
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Up to 3 years and 4 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Overall Response Rate (ORR)
Time Frame: Up to 3 years and 7 months
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ORR was defined as the percentage of participants who achieved partial response (PR) or better responses based on the computerized algorithm, in accordance with the IMWG criteria, during or after the study treatment but before the start of subsequent anti-myeloma therapy.
IMWG criteria for PR: greater than or equal to (>=)50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or less than (<)200 mg/24 hours; If the serum and urine M-protein were not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels was required in place of the M-protein criteria; If serum and urine M-protein were not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) was required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%; additionally, if present at baseline, >=50% reduction in the size of soft tissue PCs was also required.
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Up to 3 years and 7 months
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Percentage of Participants Achieving Complete Response (CR) or Better
Time Frame: Up to 3 years and 7 months
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Percentage of participants achieving CR or better were reported.
CR or better rate was defined as the percentage of participants achieving CR or sCR based on the computerized algorithm, according to IMWG response criteria.
IMWG criteria for CR: Negative immunofixation on the serum and urine, and Disappearance of any soft tissue plasmacytomas (PCs), and <5% PCs in bone marrow.
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Up to 3 years and 7 months
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Progression Free Survival (PFS)
Time Frame: Up to 3 years and 7 months
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PFS was defined as the duration from the date of randomization to either progressive disease (PD) or death, whichever comes first.
IMWG criteria for PD: >=25% from lowest response level in serum M-component (the absolute increase must be >=0.5 gram per deciliter [g/dL]) and/or in urine M-component (the absolute increase must be >=200 mg/24 hour); only in participants without measurable serum and urine M-protein levels: increase of >=25% in the difference between involved and uninvolved free light chain levels and the absolute increase must be >10 mg/dL.
BMPC%: the absolute % must be >=10%; definite increase in size of existing bone lesions or soft tissue plasmacytomas; definite development of new bone lesions or soft tissue plasmacytomas; development of hypercalcemia (corrected serum calcium >11.5 milligrams per deciliter (mg/dL) or 2.65 millimoles per liter [mmol/L]) that can be attributed solely to PC proliferative disorder.
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Up to 3 years and 7 months
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Overall Survival (OS)
Time Frame: Up to 3 years and 7 months
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OS was defined as the time from the date of randomization to the date of the participant's death due to any cause.
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Up to 3 years and 7 months
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Percentage of Participants With Negative Minimal Residual Disease (MRD)
Time Frame: Up to 3 years and 7 months
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Percentage of participants with negative MRD were reported.
MRD negativity rate, defined as the percentage of participants who had MRD negative status at 10^-5 by bone marrow aspirate after the date of randomization and prior to PD or subsequent anti-myeloma therapy.
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Up to 3 years and 7 months
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Time to Next Treatment
Time Frame: Up to 3 years and 7 months
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Time to next treatment was defined as the time from randomization to the start of the next-line treatment.
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Up to 3 years and 7 months
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Serum Concentrations of Daratumumab
Time Frame: Day 1 of Cycles 1, 3, and 7 (each cycle of 28 days) and Follow Up (post treatment Week 8; up to 30.3 months)
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Serum concentrations of daratumumab were assessed.
This outcome measure was planned to be analyzed for specified arm only.
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Day 1 of Cycles 1, 3, and 7 (each cycle of 28 days) and Follow Up (post treatment Week 8; up to 30.3 months)
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Number of Participants With Anti-recombinant Human Hyaluronidase (rHuPH20) Antibodies
Time Frame: Up to end of study; up to 30.3 months
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The incidence of anti-rHuPH20 antibodies were summarized for all participants who received at least one dose of Dara-SC and had appropriate plasma samples for detection of antibodies to rHuPH20 (at least 1 sample after the start of the first dose of Dara-SC).
This outcome measure was planned to be analyzed for specified arm only.
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Up to end of study; up to 30.3 months
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Number of Participants With Anti-Daratumumab Antibodies
Time Frame: Up to end of study; up to 30.3 months
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Number of participants who test positive for anti-daratumumab antibodies were reported.
This outcome measure was planned to be analyzed for specified arm only.
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Up to end of study; up to 30.3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 31, 2019
Primary Completion (Actual)
October 24, 2022
Study Completion (Actual)
January 10, 2023
Study Registration Dates
First Submitted
March 11, 2019
First Submitted That Met QC Criteria
March 11, 2019
First Posted (Actual)
March 12, 2019
Study Record Updates
Last Update Posted (Estimated)
December 19, 2023
Last Update Submitted That Met QC Criteria
November 29, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Dexamethasone
- Dexamethasone acetate
- BB 1101
Other Study ID Numbers
- CR108598
- 2018-004185-34 (EudraCT Number)
- 54767414MMY2065 (Other Identifier: Janssen Research & Development, LLC)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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National Cancer Institute (NCI)Active, not recruitingSmoldering Multiple Myeloma | Refractory Multiple Myeloma | DS Stage I Multiple Myeloma | DS Stage II Multiple Myeloma | DS Stage III Multiple MyelomaUnited States
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Fred Hutchinson Cancer Research Center/University...National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Mayo ClinicCompletedMultiple Myeloma | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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City of Hope Medical CenterCompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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University of WashingtonNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
Clinical Trials on Carfilzomib 20 mg/m^2
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Millennium Pharmaceuticals, Inc.CompletedMyelodysplastic Syndromes | Leukemia, Myeloid, AcuteJapan, Taiwan, Korea, Republic of
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CicloMed LLCCmed Clinical ServicesCompletedAdvanced Solid TumorsUnited States
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Spectrum Health HospitalsCompletedMultiple MyelomaUnited States
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EMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyCompletedAdvanced Solid TumorUnited States
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HighField Biopharmaceuticals CorporationRecruiting
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R-PharmTerminated
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Vanda PharmaceuticalsCompletedNon-24-Hour-Sleep-Wake Disorder
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Eisai Inc.CompletedSoft Tissue SarcomaUnited States, France, United Kingdom, Germany, Spain, Belgium, Argentina, Israel, Poland, Romania, Korea, Republic of, Canada, Netherlands, Australia, New Zealand, Singapore, Brazil, Russian Federation, Austria, Thailand, Italy, ... and more
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Eisai Inc.CompletedPurpura, Thrombocytopenic, Idiopathic | Chronic Thrombocytopenia | Acute Idiopathic Thrombocytopenic PurpuraNetherlands
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Medical College of WisconsinCompletedRelapsed Adult AMLUnited States