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Daratumumab Retreatment in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab Intravenous (Dara-IV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03871829
Recruitment Status : Recruiting
First Posted : March 12, 2019
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief 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 intravenous (Dara-IV) to evaluate daratumumab retreatment.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Carfilzomib 20 mg/m^2 Drug: Carfilzomib 70 mg/m^2 Drug: Dexamethasone 40 mg Drug: Dara-SC 1800 mg Drug: Dexamethasone 20 mg Phase 2

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 or 2 prior line(s) of treatment including a line containing Dara-IV 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Intravenous (Dara-IV) to Evaluate Daratumumab Retreatment
Actual Study Start Date : May 31, 2019
Estimated Primary Completion Date : September 14, 2022
Estimated Study Completion Date : February 10, 2023


Arm Intervention/treatment
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.
Drug: Carfilzomib 20 mg/m^2
Carfilzomib 20 mg/m^2 will be administered intravenously (IV).

Drug: Carfilzomib 70 mg/m^2
Carfilzomib 70 mg/m^2 will be administered IV.

Drug: Dexamethasone 40 mg
Dexamethasone 40 mg will be administered as IV infusion or orally.

Drug: Dexamethasone 20 mg
Dexamethasone 20 mg will be administered as IV infusion or orally.

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.
Drug: Carfilzomib 20 mg/m^2
Carfilzomib 20 mg/m^2 will be administered intravenously (IV).

Drug: Carfilzomib 70 mg/m^2
Carfilzomib 70 mg/m^2 will be administered IV.

Drug: Dexamethasone 40 mg
Dexamethasone 40 mg will be administered as IV infusion or orally.

Drug: Dara-SC 1800 mg
Dara-SC 1800 mg will be administered by SC injection.

Drug: Dexamethasone 20 mg
Dexamethasone 20 mg will be administered as IV infusion or orally.




Primary Outcome Measures :
  1. Percentage of Participants Achieving Very Good Partial Response (VGPR) or Better Response [ Time Frame: Approximately 2 years ]
    Percentage of participants achieving VGPR or better response according IMWG criteria for VGPR will be reported. 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.


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Approximately 2 years ]
    ORR is defined as percentage of participants who achieve partial response (PR) or better (including VGPR, CR, sCR) responses prior to subsequent anti-myeloma therapy. IMWG criteria for PR: >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200 mg/24 hours; If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria; If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%; additionally, if present at baseline, a >=50% reduction in the size of soft tissue PCs is also required.

  2. Percentage of Participants Achieving Complete Response (CR) or Stringent Complete Response (sCR) [ Time Frame: Approximately 2 years ]
    Complete response is based on serum M-Protein assessments. 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. IMWG criteria for sCR defined as, CR plus normal free light chain (FLC) ratio, and Absence of clonal PCs by immunohistochemistry, immunofluorescencea or 2- to 4- color flow cytometry.

  3. Progression Free Survival (PFS) [ Time Frame: Up to approximately 3.3 years ]
    PFS is time from date of randomization to date of documented progressive disease (PD) on first line treatment given for multiple myeloma (MM) 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.

  4. Overall Survival (OS) [ Time Frame: Up to approximately 3.3 years ]
    OS is defined as the time from the date of first dose of study drug to date of death due to any cause. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant will be last known to be alive.

  5. Percentage of Participants With Negative Minimal Residual Disease (MRD) [ Time Frame: Approximately 2 years ]
    Percentage of participants who have achieved MRD negative status will be assessed.

  6. Time to Next Treatment [ Time Frame: Up to approximately 3.3 years ]
    Time to next treatment is defined as the time from randomization to the start of the next-line treatment.

  7. Serum Concentrations of Daratumumab [ Time Frame: Arm A: Cycle 1 (each cycle of 28 days) Day 1 (Cycle 1 Day 1), Cycle 3 Day 1; Arm B: Cycle 1 Day1, Cycle 3 Day 1, Cycle 7 Day 1 and Follow Up (post treatment Week 8) ]
    Serum concentrations of daratumumab will be assessed.

  8. Number of Participants with Anti-Daratumumab Antibodies [ Time Frame: Arm A: Cycle 1 (each cycle of 28 days) Day 1 (Cycle 1 Day 1), Cycle 3 Day 1; Arm B: Cycle 1 Day1, Cycle 3 Day 1, Cycle 7 Day 1 and Follow Up (post treatment Week 8) ]
    Number of participants who test positive for anti-daratumumab antibodies will be reported.

  9. Number of Participants with Anti-recombinant Human Hyaluronidase (rHuPH20) Antibodies [ Time Frame: Arm A: Cycle 1 (each cycle of 28 days) Day 1 (Cycle 1 Day 1), Cycle 3 Day 1; Arm B: Cycle 1 Day1, Cycle 3 Day 1, Cycle 7 Day 1 and Follow Up (post treatment Week 8) ]
    Number of participants who test positive for anti-rHuPH20 antibodies will be reported.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 intravenously (IV) 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 or 2 prior line(s) of treatment of which one contained Dara IV, and completed Dara IV 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 Dara IV 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. 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03871829


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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United States, Arizona
Banner MD Anderson Cancer Center Recruiting
Gilbert, Arizona, United States, 85234
Oncology Institute of Hope and Innovation Recruiting
Tucson, Arizona, United States, 85745
United States, California
American Institute of Research (AIR) Recruiting
Whittier, California, United States, 90603
United States, Indiana
Fort Wayne Medical Oncology and Hematology, Inc. Recruiting
Fort Wayne, Indiana, United States, 46845
United States, Michigan
Karmanos Cancer Institute - Wayne State University Recruiting
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic - Rochester Not yet recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110-1032
United States, New York
Columbia University Medical Center Withdrawn
New York, New York, United States, 10032
Weill Medical College of Cornell University Not yet recruiting
New York, New York, United States, 10065
United States, Ohio
Cleveland Clinic Main Campus Recruiting
Cleveland, Ohio, United States, 44195
United States, Texas
Baylor Scott and White Health Not yet recruiting
Dallas, Texas, United States, 75246
Millennium Oncology Recruiting
Houston, Texas, United States, 77090
United States, Wisconsin
Medical College Of Wisconsin Withdrawn
Milwaukee, Wisconsin, United States, 43210
Belgium
ZNA Stuivenberg Recruiting
Antwerpen, Belgium, 2060
UZ Gent Recruiting
Gent, Belgium, 9000
Brazil
Universidade Estadual de Campinas (UNICAMP) - Centro De Hematologia e Hemoterapia Recruiting
Campinas, Brazil, 13083-878
Hospital Erasto Gaertner- Liga Paranaense de Combate ao Câncer Recruiting
Curitiba, Brazil, 81520-060
Hospital Das Clinicas Da Universidade Federal De Goias Recruiting
Goiânia, Brazil
Liga Norte Riograndense Contra o Cancer-Hospital Dr. Luiz Antonio Recruiting
Natal, Brazil, 59040-011
INCA - Instituto Nacional Do Cancer Recruiting
Rio De Janeiro, Brazil, 20230-130
Instituto COI de Educacao e Pesquisa Recruiting
Rio de Janeiro, Brazil, 22793-080
CEHON Not yet recruiting
Salvador, Brazil, 45995-000
Instituto de Ensino E Pesquisa Sao Lucas Not yet recruiting
Sao Paulo, Brazil, 01236-030
IBCC Instituto Brasileiro de Controle do Cancer Recruiting
Sao Paulo, Brazil, 03102-002
Hospital Beneficência Portuguesa/Hospital Israelita Albert Einstein Recruiting
Sao Paulo, Brazil, 056052-900
Clinica Sao Germano Recruiting
São Paulo, Brazil, 01455-010
Ac Camargo Cancer Center Recruiting
São Paulo, Brazil, 01509-010
Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada, T2N 4N2
Denmark
Aarhus University Hospital Recruiting
Aarhus N, Denmark, DK-8200
Haematological Research unit HFE-X OUH. Recruiting
Odense, Denmark, 5000
Vejle Hospital Recruiting
Vejle, Denmark, DK-7100
France
Hopital Claude Huriez Recruiting
Lille, France, 59037
Hotel Dieu Recruiting
Nantes, France, 44035
Hopitaux Universitaires Est Parisien Hopital Saint Antoine Recruiting
Paris, France, 75012
Fentre F Magendie, Hôpital Haut Leveque, CHU Bordeaux Recruiting
Pessac, France, 33600
Centre Hospitalier Lyon-Sud Service d'hematologie Recruiting
Pierre Benite, France, 69310
CHU Poitiers - Hôpital la Milétrie Recruiting
Poitiers, France, 86021
Institut Claudius Regaud Recruiting
Toulouse, France, 31052
CHU Bretonneau Recruiting
Tours, France, 37044
Germany
Universitätsklinik Carl Gustav Carus, Med. Klinik u. Poliklinik I Not yet recruiting
Dresden, Germany, 1307
Evangelisches Krankenhaus Essen-Werden Recruiting
Essen, Germany, 45239
Universitatsklinikum Essen Not yet recruiting
Essen, Germany, D-45147
Universitätsklinik Hamburg-Eppendorf UKE Not yet recruiting
Hamburg, Germany, 20246
St. Barbara-Klinik Hamm GmbH Recruiting
Hamm, Germany, 59075
Universitaetsklinikum Heidelberg Not yet recruiting
Heidelberg, Germany, 69120
Praxisklinik für Haematologie und Onkologie Koblenz Recruiting
Koblenz, Germany, 56068
Universitaetsklinikum Koeln Not yet recruiting
Koeln, Germany, 50397
Universitätsmedizin der Johannes gutenberg-Universität; III. Med. Klinik - Germany Not yet recruiting
Mainz, Germany, 55101
Onkologische Schwerpunkt Praxis Recruiting
Saarbrucken, Germany
Klinikum der Eberhard-Karls-Universität/Abt. für innere Med. II/Hämatologie/Onkologie-Germany Recruiting
Tubingen, Germany, 72076
Schwarzwald-Baar Klinikum Not yet recruiting
Villingen-Schwenningen, Germany, 78052
Universitätsklinikum Würzburg Med. Klinik U. Poliklinik Ii Not yet recruiting
Würzburg, Germany, 97080
Greece
Alexandra General Hospital of Athens Not yet recruiting
Athens Attica, Greece, 115 28
University of Athens - Evaggelismos Hospital (Evangelismos Hospital) Not yet recruiting
Athens, Greece, 106 76
University Hospital Of Larissa Not yet recruiting
Larisa, Greece, 41110
University General Hospital of Rio Not yet recruiting
Patra, Greece, 26500
Anticancer Hospital of Thessaloniki 'Theageneio' Not yet recruiting
Thessaloniki, Greece, 546 39
Italy
Azienda Ospedaliera Papa Giovanni XXIII Recruiting
Bergamo, Italy, 24127
Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi Recruiting
Bologna, Italy, 40138
Azienda Ospedaliera Universitaria Careggi Recruiting
Firenze, Italy, 50139
IRCCS Azienda Ospedaliera San Martino - IST Not yet recruiting
Genova, Italy, 16132
San Martino Hospital Not yet recruiting
Genova, Italy, 16132
Asst Ovest Milanese - Ospedale Di Legnano Recruiting
Legnano, Italy, 20025
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Recruiting
Meldola, Italy, 47014
ASST Grande Ospedale Metropolitano Niguarda Recruiting
Milano, Italy, 20162
Ospedale Maggiore della Carità Recruiting
Novara, Italy, 28100
Ospedale Villa Sofia-Cervello Recruiting
Palermo, Italy, 90146
Universita Degli Studi di Roma 'Tor Vergata' Not yet recruiting
Roma, Italy, 00133
Sapienza University of Rome Not yet recruiting
Roma, Italy, 00161
ASL ROMA Not yet recruiting
Roma, Italy, 30 - 00153
Fondazione Policlinico Universitario A. Gemelli IRCCS Recruiting
Rome, Italy, 00168
IRCCS Ospedale Casa Sollievo della Sofferenza Recruiting
San Giovanni Rotondo, Italy, 71013
Azienda Ospedaliera Santa Maria Not yet recruiting
Terni, Italy, 5100
Netherlands
VUMC Withdrawn
Amsterdam, Netherlands, 1081
Albert Schweitzer ziekenhuis-lokatie Dordwijk Recruiting
Dordrecht, Netherlands, 3318 AT
Zuyderland Medical Center Recruiting
Sittard, Netherlands, 6130 MB
Poland
Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy Recruiting
Bydgoszcz, Poland, 85-168
Szpital Wojewodzki w Opolu Recruiting
Opole, Poland, 45-061
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu Recruiting
Wroclaw, Poland, 50-367
Russian Federation
Emergency Hospital of Dzerzhinsk Not yet recruiting
Dzerzhinsk, Russian Federation, 606019
Nizhniy Novgorod Region Clinical Hospital Not yet recruiting
Nizhny Novgorod, Russian Federation, 603126
Ryazan Regional Clinical Hospital Not yet recruiting
Ryazan, Russian Federation, 390003
Samara Region Clinical Hospital Not yet recruiting
Samara, Russian Federation, 443095
Oncological dispensary #2 Not yet recruiting
Sochi, Russian Federation, 354057
Clinical Research Institute of Hematology and Transfusiology Not yet recruiting
St-Petersburg, Russian Federation, 191024
Oncology Dispensary of Komi Republic Not yet recruiting
Syktyvkar, Russian Federation, 167904
Spain
Hosp. Clinic I Provincial de Barcelona Recruiting
Barcelona, Spain, 08036
Inst. Cat. Doncologia-H Duran I Reynals Recruiting
Barcelona, Spain, 08908
Hosp. de Leon Recruiting
Leon, Spain, 24080
Hosp. Univ. Ramon Y Cajal Recruiting
Madrid, Spain, 28034
Hosp. Univ. 12 de Octubre Recruiting
Madrid, Spain, 28041
Hosp. Univ. de La Paz Recruiting
Madrid, Spain, 28046
Hosp. Costa Del Sol Recruiting
Malaga, Spain, 29603
Hosp. Univ. Son Espases Recruiting
Palma, Spain, 7120
Clinica Univ. de Navarra Recruiting
Pamplona, Spain, 31008
Hosp. Clinico Univ. de Salamanca Recruiting
Salamanca, Spain, 37007
Hosp. Univ. de Canarias Not yet recruiting
San Cristóbal de La Laguna, Spain, 38320
Hosp. Virgen Del Rocio Not yet recruiting
Sevilla, Spain, 41013
Hosp. Virgen de La Salud Not yet recruiting
Toledo, Spain, 45071
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Additional Information:
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03871829    
Other Study ID Numbers: CR108598
2018-004185-34 ( EudraCT Number )
54767414MMY2065 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Daratumumab
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors