Multiple Myeloma Clinical Trial

Daratumumab Retreatment in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab

Summary

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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 start and not agreeing to ART be on>4 weeks plus having HIV viral load <400 copiesmilliliters (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 surface antigen [HBsAg]). Participants with resolved infection (example: participants who are HBsAg negative but antibodies to core [anti-HBc]or [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement virus (HBV) deoxyribonucleic acid (DNA) levels. Those PCR will excluded. c) Known seropositive C (except in the setting sustained virologic response [SVR], defined as aviremia least 12 weeks after completion antiviral therapy)

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

230

Study ID:

NCT03871829

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 110 Locations for this study

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Banner MD Anderson Cancer Center
Gilbert Arizona, 85234, United States
Oncology Institute of Hope and Innovation
Tucson Arizona, 85745, United States
American Institute of Research (AIR)
Whittier California, 90603, United States
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne Indiana, 46804, United States
Karmanos Cancer Institute - Wayne State University
Detroit Michigan, 48201, United States
Mayo Clinic - Rochester
Rochester Minnesota, 55905, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Columbia University Medical Center
New York New York, 10032, United States
Weill Medical College of Cornell University
New York New York, 10065, United States
Cleveland Clinic Main Campus
Cleveland Ohio, 44195, United States
Baylor Scott and White Health
Dallas Texas, 75246, United States
Millennium Oncology
Houston Texas, 77090, United States
Medical College Of Wisconsin
Milwaukee Wisconsin, 53226, United States
ZNA Stuivenberg
Antwerpen , 2060, Belgium
UZ Gent
Gent , 9000, Belgium
Universidade Estadual De Campinas
Campinas , 13083, Brazil
Hospital Erasto Gaertner- Liga Paranaense de Combate ao Câncer
Curitiba , 81520, Brazil
Hospital Das Clinicas Da Universidade Federal De Goias
Goiânia , , Brazil
Liga Norte Riograndense Contra O Cancer
Natal , 59062, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre , 90050, Brazil
Centro Gaucho Integrado De Oncologia
Porto Alegre , 90110, Brazil
Ministerio da Saude - Instituto Nacional do Cancer
Rio de Janeiro , 20230, Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Rio de Janeiro , 22793, Brazil
Hospital Sao Rafael
Salvador , 41253, Brazil
CEHON
Salvador , 45995, Brazil
Instituto de Ensino e Pesquisa São Lucas
Sao Paulo , 01236, Brazil
Fundação Antônio Prudente - A.C. Camargo Cancer Center
Sao Paulo , 01509, Brazil
Instituto Brasileiro de Controle do Cancer - Sao Camilo Oncologia
Sao Paulo , 03102, Brazil
Real e Benemérita Associação Portuguesa de Beneficência
São Paulo , 01321, Brazil
Clinica Sao Germano
São Paulo , 01455, Brazil
Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada
Aarhus University Hospital
Aarhus N , DK-82, Denmark
Regionshospitalet i Holstebro
Holstebro , 7500, Denmark
Haematological Research unit HFE-X OUH.
Odense , 5000, Denmark
Vejle Hospital
Vejle , DK-71, Denmark
Hopital Claude Huriez
Lille , 59037, France
CHU de Montpellier, Hopital Saint-Eloi
Montpellier , 34295, France
Centre Hospitalier Emile Muller
Mulhouse , 68100, France
Hotel Dieu
Nantes , 44035, France
Hopitaux Universitaires Est Parisien Hopital Saint Antoine
Paris , 75012, France
Hopital de la Pitie Salpetriere
Paris , 75013, France
Hôpital Necker-Enfants Malades
Paris , 75743, France
Fentre F Magendie, Hôpital Haut Leveque, CHU Bordeaux
Pessac , 33600, France
Centre Hospitalier Lyon-Sud Service d'hematologie
Pierre Benite , 69310, France
CHU Poitiers - Hôpital la Milétrie
Poitiers , 86021, France
Chu Rennes - Hopital Pontchaillou
Rennes Cedex , 35033, France
Institut Claudius Regaud
Toulouse , 31052, France
CHU Bretonneau
Tours , 37044, France
CHU Nancy Brabois
Vandoeuvre Les Nancy , 54511, France
Universitätsklinik Carl Gustav Carus, Med. Klinik u. Poliklinik I
Dresden , 1307, Germany
Evangelisches Krankenhaus Essen-Werden
Essen , 45239, Germany
Universitatsklinikum Essen
Essen , D-451, Germany
Universitätsklinik Hamburg-Eppendorf UKE
Hamburg , 20246, Germany
St. Barbara-Klinik Hamm GmbH
Hamm , 59075, Germany
Universitaetsklinikum Heidelberg
Heidelberg , 69120, Germany
Praxisklinik für Haematologie und Onkologie Koblenz
Koblenz , 56068, Germany
Universitaetsklinikum Koeln
Koeln , 50397, Germany
Universitätsmedizin der Johannes gutenberg-Universität; III. Med. Klinik - Germany
Mainz , 55101, Germany
Onkologische Schwerpunkt Praxis
Saarbrucken , , Germany
Klinikum der Eberhard-Karls-Universität/Abt. für innere Med. II/Hämatologie/Onkologie-Germany
Tubingen , 72076, Germany
Schwarzwald-Baar Klinikum
Villingen-Schwenningen , 78052, Germany
Universitätsklinikum Würzburg Med. Klinik U. Poliklinik Ii
Würzburg , 97080, Germany
Alexandra General Hospital of Athens
Athens Attica , 115 2, Greece
University of Athens - Evaggelismos Hospital (Evangelismos Hospital)
Athens , 106 7, Greece
University Hospital Of Larissa
Larisa , 41110, Greece
University General Hospital of Rio
Patra , 26500, Greece
Anticancer Hospital of Thessaloniki 'Theageneio'
Thessaloniki , 546 3, Greece
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo , 24127, Italy
Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi
Bologna , 40138, Italy
Azienda Ospedaliera Universitaria Careggi
Firenze , 50139, Italy
IRCCS Azienda Ospedaliera San Martino - IST
Genova , 16132, Italy
San Martino Hospital
Genova , 16132, Italy
Asst Ovest Milanese - Ospedale Di Legnano
Legnano , 20025, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola , 47014, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milano , 20162, Italy
Ospedale Maggiore della Carità
Novara , 28100, Italy
Casa di Cura La Maddalena
Palermo , 90146, Italy
Ospedale Villa Sofia-Cervello
Palermo , 90146, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia , 27100, Italy
Universita Degli Studi di Roma 'Tor Vergata'
Roma , 00133, Italy
Sapienza University of Rome
Roma , 00161, Italy
ASL ROMA
Roma , 30 - , Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome , 00168, Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo , 71013, Italy
Azienda Ospedaliera Santa Maria
Terni , 5100, Italy
VUMC
Amsterdam , 1081, Netherlands
Albert Schweitzer ziekenhuis-lokatie Dordwijk
Dordrecht , 3318 , Netherlands
Zuyderland Medical Center
Sittard , 6130 , Netherlands
Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy
Bydgoszcz , 85-16, Poland
Szpital Wojewodzki w Opolu
Opole , 45-06, Poland
Szpital Magodent
Warszawa , 01-74, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw , 50-36, Poland
Emergency Hospital of Dzerzhinsk
Dzerzhinsk , 60601, Russian Federation
S.P. Botkin Moscow City Clinical Hospital
Moscow , 12528, Russian Federation
Nizhniy Novgorod Region Clinical Hospital
Nizhny Novgorod , 60312, Russian Federation
Ryazan Regional Clinical Hospital
Ryazan , 39000, Russian Federation
Samara Region Clinical Hospital
Samara , 44309, Russian Federation
Oncological dispensary #2
Sochi , 35405, Russian Federation
Clinical Research Institute of Hematology and Transfusiology
St-Petersburg , 19102, Russian Federation
Oncology Dispensary of Komi Republic
Syktyvkar , 16790, Russian Federation
Hosp. Clinic I Provincial de Barcelona
Barcelona , 08036, Spain
Inst. Cat. Doncologia-H Duran I Reynals
Barcelona , 08908, Spain
Hosp. de Jerez de La Frontera
Jerez de la Frontera , 11407, Spain
Hosp. de Leon
Leon , 24080, Spain
Hosp. Univ. Ramon Y Cajal
Madrid , 28034, Spain
Hosp. Univ. 12 de Octubre
Madrid , 28041, Spain
Hosp. Univ. de La Paz
Madrid , 28046, Spain
Hosp. Costa Del Sol
Malaga , 29603, Spain
Hosp. Univ. Son Espases
Palma , 7120, Spain
Clinica Univ. de Navarra
Pamplona , 31008, Spain
Hosp. Clinico Univ. de Salamanca
Salamanca , 37007, Spain
Hosp. Univ. de Canarias
San Cristóbal de La Laguna , 38320, Spain
Hosp. Virgen Del Rocio
Sevilla , 41013, Spain
Hosp. Gral. Univ. de Toledo
Toledo , 45007, Spain

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

230

Study ID:

NCT03871829

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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