Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens

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: NCT03412565
Recruitment Status : Recruiting
First Posted : January 26, 2018
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in participants with MM as measured by overall response rate (ORR) or very good partial response (VGPR) or better rate.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Daratumumab Drug: Bortezomib Drug: Lenalidomide Drug: Dexamethasone Drug: Melphalan Drug: Prednisone Drug: Carfilzomib Phase 2

Detailed Description:
The hypothesis is that the addition of daratumumab administered SC to standard MM regimens will improve responses compared to response data observed in completed phase 3 studies without daratumumab. Disease evaluations will include measurements of myeloma proteins, bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected for albumin. Safety will be measured by adverse events, laboratory test results, electrocardiogram (ECGs), vital sign measurements, physical examination findings, SC injection-site assessments, and assessment of Eastern Cooperative Oncology Group (ECOG) performance status score. Study will consist of 3 phases (screening, treatment and follow-up) and duration of study is approximately 3 years.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Phase 2 Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens
Actual Study Start Date : April 26, 2018
Estimated Primary Completion Date : September 27, 2020
Estimated Study Completion Date : November 26, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Daratumumab

Arm Intervention/treatment
Experimental: Daratumumab(D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)
Participants will receive daratumumab 1800 milligram (mg) by subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligram per square meter (mg/m^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4.
Drug: Daratumumab
Daratumumab will be administered at a dose of 1800 mg by SC injection in Cycles 1 to 4 in D-VRd cohort and until documented progression of disease, unacceptable toxicity, or end of study for D-VMP, D-Rd and D-Kd cohorts.

Drug: Bortezomib
Bortezomib will be administered as 1.3 mg/m^2 SC injection in Cycles 1 to 4 in D-VRd cohort and in Cycles 1 to 9 in D-VMP cohort.

Drug: Lenalidomide
Lenalidomide will be administered as 25 mg capsule orally in Cycles 1 to 4 in D-VRd cohort and in all Cycles until documented progression of disease, unacceptable toxicity, or end of study in D-Rd cohort.

Drug: Dexamethasone
Dexamethasone will be administered as 20 mg orally or intravenously in Cycles 1 to 4 in D-VRd cohort; 40 mg orally or intravenously in all cycles and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Rd and D-Kd cohort.

Experimental: D + Bortezomib + Melphalan + Prednisone (D-VMP)
Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1 then on Days 1 and 22 in Cycles 2 to 9 and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9.
Drug: Daratumumab
Daratumumab will be administered at a dose of 1800 mg by SC injection in Cycles 1 to 4 in D-VRd cohort and until documented progression of disease, unacceptable toxicity, or end of study for D-VMP, D-Rd and D-Kd cohorts.

Drug: Bortezomib
Bortezomib will be administered as 1.3 mg/m^2 SC injection in Cycles 1 to 4 in D-VRd cohort and in Cycles 1 to 9 in D-VMP cohort.

Drug: Melphalan
Melphalan will be administered as 9 mg/m^2 orally in Cycles 1 to 9.

Drug: Prednisone
Prednisone will be administered as 60 mg/m^2 orally in cycles 1 to 9.

Experimental: Daratumumab + Lenalidomide + Dexamethasone (D-Rd)
Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 then on Day 1 and 15 of Cycles 3 to 6 and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or end of study.
Drug: Daratumumab
Daratumumab will be administered at a dose of 1800 mg by SC injection in Cycles 1 to 4 in D-VRd cohort and until documented progression of disease, unacceptable toxicity, or end of study for D-VMP, D-Rd and D-Kd cohorts.

Drug: Lenalidomide
Lenalidomide will be administered as 25 mg capsule orally in Cycles 1 to 4 in D-VRd cohort and in all Cycles until documented progression of disease, unacceptable toxicity, or end of study in D-Rd cohort.

Drug: Dexamethasone
Dexamethasone will be administered as 20 mg orally or intravenously in Cycles 1 to 4 in D-VRd cohort; 40 mg orally or intravenously in all cycles and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Rd and D-Kd cohort.

Experimental: Daratumumab + Carfilzomib + Dexamethasone (D-Kd)
Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days) then on Day 1 and 15 of Cycles 3 to 6 and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; Carfilzomib 20 mg/m^2 intravenously (IV) on Day 1 of Cycle 1 only then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or IV weekly for Cycles 1-9 then on Days 1, 8, 15 of each cycle for Cycles 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study.
Drug: Daratumumab
Daratumumab will be administered at a dose of 1800 mg by SC injection in Cycles 1 to 4 in D-VRd cohort and until documented progression of disease, unacceptable toxicity, or end of study for D-VMP, D-Rd and D-Kd cohorts.

Drug: Dexamethasone
Dexamethasone will be administered as 20 mg orally or intravenously in Cycles 1 to 4 in D-VRd cohort; 40 mg orally or intravenously in all cycles and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Rd and D-Kd cohort.

Drug: Carfilzomib
Carfilzomib will be administered as 20 mg/m^2 IV on Day 1 of Cycle 1 only then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Kd cohort.




Primary Outcome Measures :
  1. D-VMP, D-Kd, and D-Rd Cohort: Overall Response Rate (ORR) [ Time Frame: 18 months after the last participant enrolled (approximately 2.5 years) ]
    The ORR is defined as the percentage of participants who achieve partial response (PR) or better according to international myeloma working group (IMWG) criteria, during or after study treatment for D-VMP, D-Kd and D-Rd cohorts. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 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%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.

  2. D-VRd Cohort: Very Good Partial Response (VGPR) or Better Rate [ Time Frame: 18 months after the last participant enrolled (approximately 2.5 years) ]
    The VGPR or better rate, defined as the percentage of participants achieving VGPR or better according IMWG criteria during or after the study treatment in Daratumumab + Bortezomib + Lenalidomide + Dexamethasone (D-VRd) cohort. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >= 90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligram per 24 hours (mg/24 hours).


Secondary Outcome Measures :
  1. Maximum Observed Serum Concentrations (Cmax) of Daratumumab [ Time Frame: D-VRd: Day 4 of Cycles 1 and 4 and post treatment 4 weeks and at week 8; D-VMP and D-Rd: Day 4 of Cycles 1 and 2 and post treatment 4 weeks and at week 8; D-Kd: Day 4 of Cycles 1 and 3 and post treatment 4 weeks and at week 8 ]
    Cmax is defined as maximum concentration observed following daratumumab administration.

  2. Minimum Observed Serum Concentrations (Cmin) of Daratumumab [ Time Frame: D-VRd: predose on Day 1 of Cycles 1, 3, and 4; D-VMP: predose on Day 1 of Cycles 1, 2, 3, 6 and 9; D-Rd: predose on Day 1 of Cycles 1, 3, 6, 9 and 12 and D-Kd: predose on Day 1 of Cycles 1, 3, 6, 9, and 12 ]
    Cmin is defined as the minimum concentration observed immediately before daratumumab administration.

  3. Percentage of Participants with Infusion-Related Reactions (IRR) [ Time Frame: 18 months after the last participant enrolled (approximately 2.5 years) ]
    The Percentage of Participants with infusion reactions will be reported.

  4. D-Kd, D-VMP, and D-Rd Cohort: Very Good Partial Response (VGPR) or Better Rate [ Time Frame: 18 months after the last participant enrolled (approximately 2.5 years) ]
    The VGPR or better rate, defined as the percentage of participants achieving VGPR or better rate according IMWG criteria during or after the study treatment for Daratumumab + Carfilzomib + Dexamethasone (D-Kd), Daratumumab + Bortezomib + Melphalan + Prednisone (D-VMP), and Daratumumab + Lenalidomide + Dexamethasone (D-Rd) cohorts. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or greater than equal to (>=) 90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligram (mg)/24 hours.

  5. D-VRd Cohort: Overall Response Rate (ORR) [ Time Frame: 18 months after the last participant enrolled (approximately 2.5 years) ]
    The ORR is defined as the proportion of participants who achieve partial response (PR) or better according to IMWG criteria, during or after study treatment for D-VRd cohort. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 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%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.

  6. Complete Response or Better Rate [ Time Frame: 18 months after the last participant enrolled (approximately 2.5 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, and <5% PCs in bone marrow. Stringent complete response (sCR): CR plus normal FLC ratio, and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4 color flow cytometry.

  7. Duration of Response (DOR) [ Time Frame: 18 months after the last participant enrolled (approximately 2.5 years) ]
    Duration of response is defined as the time from the date of initial documented response (PR or better for D-Kd, D-VMP, D-Rd, and D-VRd cohorts) to the date of first documented evidence of progressive disease or death due to progressive disease (PD).

  8. Number of Participants with Anti-Drug Antibodies Against Daratumumab or Recombinant Human Hyaluronidase (rHuPH20) [ Time Frame: Up to 8 weeks after the last dose of study drug (approximately 1 year) ]
    Participants with anti-drug antibodies against daratumumab or rHuPH20 will be analyzed.

  9. D-Kd, D-VMP, and D-Rd Cohorts: Percentage of Participants who are Minimal Residual Disease (MRD) Negative [ Time Frame: 18 months after the last participant enrolled (approximately 2.5 years) ]
    Percentage of participants who are MRD negative will be assessed for D-Kd, D-VMP, and D-Rd cohorts. MRD negative is defined as less than (<) 0.01% abnormal population counts to total event counts when measured by flow.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Multiple myeloma diagnosed according to the International Myeloma Working Group (IMWG) diagnostic criteria
  • Measurable, secretory disease as defined by any of the following:

    1. Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL); or
    2. Urine M-protein level >= 200 milligram per 24 hours (mg/24 hours); or
    3. Light chain multiple myeloma (MM), for participants without measurable disease in the serum or urine: serum Immunoglobulin (Ig) free light chain (FLC) >= 10 mg/dL and abnormal FLC ratio
  • Meets one of the sets of the following criteria:

    1. For Daratumumab + bortezomib + lenalidomide + dexamethasone (D-VRd) and Daratumumab + bortezomib + melphalan + prednisone + dexamethasone (D-VMP) regimen: newly diagnosed myeloma
    2. For Daratumumab + lenalidomide + dexamethasone (D-Rd) and Daratumumab + Carfilzomib + Dexamethasone (D-Kd) regimen: relapsed or refractory disease
    3. D-Kd cohort: Participants must have received only 1 prior line of therapy for MM which included at least 2 consecutive cycles of lenalidomide therapy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0, 1, or 2
  • During the study, and for 3 months after receiving the last dose of daratumumab, a woman must agree not to donate eggs (ova, oocytes) and men must agree not to donate sperm for the purposes of assisted reproduction

Exclusion Criteria:

  • History of malignancy (other than MM) unless all treatment of that malignancy was completed at least 2 years before consent and the participant 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
  • Exhibits clinical signs of meningeal involvement of MM
  • Either of the following: a) Chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) is less than (<) 50 percentage (%) of predicted normal b) Moderate or severe persistent asthma, or a history of asthma within the last 2 years, or currently has uncontrolled asthma of any classification c) For D-Kd cohort: Known infiltrative pulmonary disease or known pulmonary hypertension
  • Any of the following: 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 (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) DNA levels. Those who are polymerase chain reaction (PCR) positive will be excluded
  • Known to be seropositive for hepatitis C (Anti-HCV antibody positive or HCV-RNA quantitation positive) except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy
  • For D-Kd cohort only: Transthoracic echocardiogram showing left ventricular ejection fraction (LVEF) <40%; uncontrolled hypertension, defined as an average systolic blood pressure greater than (>)159 millimeters of mercury (mmHg) or diastolic >99 mmHg despite optimal treatment

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): NCT03412565


Contacts
Layout table for location contacts
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

  Hide Study Locations
Locations
Layout table for location information
United States, Connecticut
University of Connecticut Withdrawn
Farmington, Connecticut, United States, 06030
Cancer Center of Central Connecticut - Southington Completed
Southington, Connecticut, United States, 06489-3237
United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Watson Clinic Llp Withdrawn
Lakeland, Florida, United States, 33805
UF Health Cancer Center at Orlando Health Recruiting
Orlando, Florida, United States, 32806
United States, Iowa
University of Iowa Hospitals & Clinics Withdrawn
Iowa City, Iowa, United States, 52242
United States, Maryland
University of Maryland Withdrawn
Baltimore, Maryland, United States, 21201
United States, Michigan
Karmonos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Providence Cancer Center Recruiting
Southfield, Michigan, United States, 48075
United States, Montana
Billings Clinic Recruiting
Billings, Montana, United States, 59101
United States, Nebraska
Nebraska Hematology and Oncology Completed
Lincoln, Nebraska, United States, 68506
Southeast Nebraska Cancer Center Completed
Lincoln, Nebraska, United States, 68510
Nebraska Cancer Specialists Recruiting
Omaha, Nebraska, United States, 68130
University of Nebraska Medical Center Withdrawn
Omaha, Nebraska, United States, 68198
United States, New Jersey
The Valley Hospital Withdrawn
Ridgewood, New Jersey, United States, 07450
United States, New Mexico
San Juan Oncology Associates Completed
Farmington, New Mexico, United States, 87401
United States, New York
St Francis Hospital Withdrawn
East Hills, New York, United States, 11548
Queens Medical Associates, PC Withdrawn
Fresh Meadows, New York, United States, 11366
Northwell Health Withdrawn
Lake Success, New York, United States, 11042
NYU Winthrop Completed
Mineola, New York, United States, 11501
Mt. Sinai School of Medicine Recruiting
New York, New York, United States, 10029
United States, North Carolina
University of North Carolina Withdrawn
Chapel Hill, North Carolina, United States, 27599
Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, South Carolina
Gibbs Cancer Center Withdrawn
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Avera Medical Group - Oncology & Hematology Recruiting
Sioux Falls, South Dakota, United States, 57105
United States, Utah
Utah Cancer Specialists Recruiting
Salt Lake City, Utah, United States, 84121
United States, Virginia
University of Virginia Cancer Center - Emily Couric Clinical Cancer Center - Women's Oncology Clinic Completed
Charlottesville, Virginia, United States, 22903
United States, Washington
Virginia Mason Medical Center Withdrawn
Seattle, Washington, United States, 98101
Brazil
Instituto Do Cancer Do Ceara Withdrawn
Fortaleza, Brazil, 60430-230
Liga Norte Riograndense Contra O Cancer Active, not recruiting
Natal, Brazil, 59075-740
Centro de Pesquisa do Instituto do Câncer- Hospital São Vicente de Paulo Completed
Passo Fundo, Brazil, 99010-090
Hospital Mãe de Deus Center Withdrawn
Porto Alegre, Brazil, 90470-340
Instituto Nacional do Cancer - INCA Completed
Rio de Janeiro, Brazil, 20230-130
Universidade Federal de Sao Paulo Active, not recruiting
Sao Paulo, Brazil, 04037-002
Hospital do Servidor Publico Estadual - IAMSPE Completed
Sao Paulo, Brazil
Clinica Sao Germano Active, not recruiting
São Paulo, Brazil, 01455-010
Czechia
Fakultni nemocnice Brno Recruiting
Brno, Czechia, 625 00
Fakultni nemocnice Hradec Kralove Recruiting
Hradec Kralove, Czechia, 500 05
Fakultni nemocnice Ostrava Recruiting
Ostrava, Czechia, 70852
Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie Completed
Praha 2, Czechia, 128 08
France
CHU de Nantes hôtel-Dieu Recruiting
Nantes Cedex 1, France, 44093
CHU de Bordeaux - Hôpital Haut-Lévêque Recruiting
Pessac cedex, France, 33604
Centre hospitalier Lyon-Sud Recruiting
Pierre-Bénite, France, 69495
CHU Bretonneau Recruiting
Tours Cedex 9, France, 37044
CHU Nancy Brabois Recruiting
Vandoeuvre Les Nancy, France, 54511
Germany
Klinikum Chemnitz gGmbH Recruiting
Chemnitz, Germany, 09113
Universitaetsklinikum Hamburg Eppendorf Not yet recruiting
Hamburg, Germany, 20246
Asklepios Klinik Altona Recruiting
Hamburg, Germany, 22763
Universitaetsklinikum Heidelberg Recruiting
Heidelberg, Germany, 69120
Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II, Recruiting
Tübingen, Germany, 72076
Israel
Rambam Medical Center Active, not recruiting
Haifa, Israel, 31096
Carmel Medical Center Active, not recruiting
Haifa, Israel, 3436212
Hadassah Medical Center Completed
Jerusalem, Israel, 9112001
Galilee Medical Center Active, not recruiting
Nahariya, Israel, 22100
Sheba Medical Center Active, not recruiting
Ramat Gan, Israel, 52621
Tel-Aviv Sourasky Medical Center Active, not recruiting
Tel-Aviv, Israel, 64239
Japan
Kanazawa University Hospital Active, not recruiting
Kanazawa, Japan, 920-8641
Matsuyama Red Cross Hospital Completed
Matsuyama, Japan, 790-8524
Nagoya City University Hospital Active, not recruiting
Nagoya, Japan, 467-8602
Japanese Red Cross Central Medical Center Active, not recruiting
Shibuya, Japan, 150-8935
Korea, Republic of
Keimyung University Dongsan Hospital Withdrawn
Daegu, Korea, Republic of, 700-712
Yeungnam University Medical Center Withdrawn
Daegu, Korea, Republic of, 705-703
Chungnam National University Hospital Withdrawn
Daejeon, Korea, Republic of, 35015
Chonnam National University Hwasun Hospital Withdrawn
Hwasun Gun, Korea, Republic of, 58128
Seoul National University Bundang Hospital Withdrawn
Seongnam-si, Korea, Republic of, 13620
Korea Cancer Center Hospital Withdrawn
Seoul, Korea, Republic of, 01812
Seoul National University Hospital Withdrawn
Seoul, Korea, Republic of, 03080
Spain
Inst. Cat. D'Oncologia-Badalona Recruiting
Badalona, Spain, 08916
Hosp. Univ. Vall D Hebron Recruiting
Barcelona, Spain, 08035
Hosp. Clinic I Provincial de Barcelona Recruiting
Barcelona, Spain, 08036
Inst. Cat. Doncologia-H Duran I Reynals Recruiting
Barcelona, Spain, 08908
Hosp. Gral. Univ. Gregorio Maranon Recruiting
Madrid, Spain, 28007
Clinica Univ. de Navarra Recruiting
Madrid, Spain, 28027
Hosp. Univ. Ramon Y Cajal Recruiting
Madrid, Spain, 28034
Hosp. Univ. 12 de Octubre Recruiting
Madrid, Spain, 28041
Hosp. Son Llatzer Recruiting
Mallorca, Spain, 07198
Clinica Univ. de Navarra Recruiting
Pamplona, Spain, 31008
Hosp. Clinico Univ. de Salamanca Recruiting
Salamanca, Spain, 37007
Hosp. Univ. Dr. Peset Recruiting
Valencia, Spain, 46017
United Kingdom
Heart of England NHS Foundation Trust Recruiting
Birmingham, United Kingdom, B9 5SS
Royal Bournemouth Hospital Recruiting
Bournemouth, United Kingdom, BH7 7DW
Kent and Canterbury Hospital Recruiting
Canterbury, United Kingdom, CT1 3NG
Manchester Royal Infirmary Recruiting
Manchester, United Kingdom, M13 9WL
Derriford Hospital Recruiting
Plymouth, United Kingdom, PL6 8DH
Royal Stoke University Hospital Recruiting
Stoke on Trent, United Kingdom, ST4 6QG
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Layout table for investigator information
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Additional Information:
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03412565     History of Changes
Other Study ID Numbers: CR108435
2017-004203-41 ( EudraCT Number )
54767414MMY2040 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Myeloma
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
Prednisone
Lenalidomide
Bortezomib
Melphalan
Daratumumab
BB 1101
Antibodies, Monoclonal
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids