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Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02252172
Recruitment Status : Active, not recruiting
First Posted : September 30, 2014
Results First Posted : January 9, 2020
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The purpose of this study is to compare the efficacy of daratumumab in combination with lenalidomide and dexamethasone to that of lenalidomide and dexamethasone in terms of progression-free survival (PFS) in participants with newly diagnosed multiple myeloma (a blood cancer of plasma cells) who are not candidates for high dose chemotherapy (treatment of disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT).

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Daratumumab IV Drug: Lenalidomide Drug: Dexamethasone Drug: Daratumumab SC Phase 3

Detailed Description:
This is a Phase 3, randomized (study drug assigned by chance), open-label (participants and researchers are aware about the treatment, participants are receiving), active-controlled (study in which the experimental treatment or procedure is compared to a standard treatment or procedure), parallel-group (each group of participants will be treated at the same time), and multicenter (when more than one hospital or medical school team work on a medical research study) study in participants with newly diagnosed multiple myeloma and who are not candidates for high dose chemotherapy and ASCT. All the eligible participants will be randomly assigned to receive either lenalidomide and dexamethasone (Rd) (Arm A) or daratumumab in combination with lenalidomide and dexamethasone (DRd) (Arm B). Daratumumab (16 milligram per kilogram [mg/kg]) will be administered weekly for first 8 weeks (Cycles 1 to 2) of treatment and then every other week for 16 weeks (Cycles 3 to 6), then every 4 weeks (from Cycle 7 and beyond) until progression of disease or unacceptable toxicity. Lenalidomide will be administered at a dose of 25 mg orally on Days 1 through 21 of each 28-day cycle, and dexamethasone will be administered at a dose of 40 mg once a week for both treatment arms. Participants in both treatment arms will continue lenalidomide and dexamethasone until disease progression or unacceptable toxicity. All participants randomized to Treatment Arm B (DRd) in this study initially received daratumumab IV formulation; however, following implementation of protocol amendment 8, participants still receiving treatment with daratumumab IV will have the option to switch to daratumumab SC on Day 1 of any cycle, at the discretion of the investigator. Daratumumab subcutaneous (SC) will be administered by SC injection at a fixed dose of 1800 mg once every 4 weeks until documented progression, unacceptable toxicity, or study completion. Participants in Arm A who have sponsor-confirmed disease progression may have the option to receive daratumumab provided by the sponsor (in any subsequent line of therapy) in the Follow-up phase. The study consists of 3 phases: Screening Phase (within 21 days prior to the first dose administration on Day 1), Treatment Phase (Day 1 up to discontinuation of all study treatment), and Follow-up Phase (from discontinuation of all study treatment up to death, lost to follow up, consent withdrawal, or study end, whichever occurs first). The maximum duration of study will be 7 years after last participant is randomized. Efficacy will primarily be evaluated by PFS. Participants' safety will be monitored throughout the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 737 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High Dose Therapy
Actual Study Start Date : February 16, 2015
Actual Primary Completion Date : September 24, 2018
Estimated Study Completion Date : March 30, 2024


Arm Intervention/treatment
Active Comparator: Lenalidomide and Dexamethasone (Rd)
Participants will receive Lenalidomide 25 mg capsule orally on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously once a week. Study treatment continues until disease progression, unacceptable toxicity, or end of study (maximum up to 7 years after last subject is randomized) whichever comes first.
Drug: Daratumumab IV
Daratumumab will be administered at a dose of 16 milligram per kilogram (mg/kg) by intravenous (IV) infusion, once a week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression of disease, unacceptable toxicity, or end of study (maximum up to 7 years).
Other Name: JNJ-54767414

Drug: Lenalidomide
Lenalidomide 25 mg capsule orally on Day 1 through Day 21 of each 28-day cycle.

Drug: Dexamethasone
Dexamethasone 40 mg orally or intravenously once in a week.

Active Comparator: Daratumumab + Lenalidomide + Dexamethasone (DRd)
Participants will receive Daratumumab 16 milligram per kilogram (mg/kg) by intravenous infusion, once a week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks, Lenalidomide 25 mg capsule orally on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously once a week. Following implementation of protocol amendment 8, participants still receiving treatment with daratumumab IV will have the option to switch to daratumumab SC on Day 1 of any cycle, at the discretion of the investigator. Daratumumab subcutaneous (SC) will be administered by SC injection at a fixed dose of 1800 mg once every 4 weeks until documented progression, unacceptable toxicity, or study completion. Study treatment continues until disease progression, unacceptable toxicity, or end of study (maximum up to 7 years after last subject is randomized) whichever comes first.
Drug: Lenalidomide
Lenalidomide 25 mg capsule orally on Day 1 through Day 21 of each 28-day cycle.

Drug: Dexamethasone
Dexamethasone 40 mg orally or intravenously once in a week.

Drug: Daratumumab SC
Daratumumab SC will be administered by SC injection at a fixed dose of 1800 mg once every 4 weeks until documented progression, unacceptable toxicity, or study end. Following implementation of protocol amendment 8, participants still receiving treatment with daratumumab IV will have the option to switch to daratumumab SC on Day 1 of any cycle, at the discretion of the investigator.
Other Name: JNJ-54767414




Primary Outcome Measures :
  1. Primary: Progression-free Survival (PFS) [ Time Frame: From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or clinical cut-off (CCO) whichever occurs first (up to 3.5 years) ]
    PFS is defined as time from date of randomization to either progressive disease (PD) or death, whichever occurs first based on computerized algorithm as per International Myeloma Working Group (IMWG) criteria. PD is defined as an increase of 25 percent (%) from the lowest response value in one of the following: serum and urine M-component (absolute increase must be greater than or equal to [>=] 0.5 gram per deciliter [g/dL] and >=200 milligram [mg]/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be greater than [>]10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to Plasma cell (PC) proliferative disorder.


Secondary Outcome Measures :
  1. Percentage of Participants With Complete Response (CR) or Better [ Time Frame: From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years) ]
    CR or better is defined as percentage of participants with a CR or better (CR or stringent complete response [sCR]) based on computerized algorithm as per IMWG criteria. CR is defined as negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and less than (<) 5 percent (%) PCs in bone marrow. In participants with only measurable disease by serum FLC levels a normal serum FLC ratio is required. sCR is defined as in addition to CR a normal FLC ratio, and absence of clonal PCs by immunohistochemistry or immunofluorescence or 2 to 4-color flow cytometry.

  2. Percentage of Participants With Very Good Partial Response (VGPR) or Better [ Time Frame: From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years) ]
    VGPR or better is defined as the percentage of participants with a response of VGPR or better (VGPR, CR or sCR) based on computerized algorithm as per IMWG criteria. VGPR is defined as serum and urine M-component detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours. In participants with only measurable disease by serum FLC levels a >90% decrease in the difference between involved and uninvolved FLC levels is required.

  3. Percentage of Participants With Negative Minimal Residual Disease (MRD) [ Time Frame: From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years) ]
    MRD negativity rate is defined as the percentage of participants who had negative MRD (detection of less than 1 malignant cell among 100,000 normal cells) assessment at any timepoint after the date of randomization by evaluation of bone marrow aspirates. MRD was assessed in participants who achieved CR or better.

  4. Overall Response Rate (ORR) [ Time Frame: From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years) ]
    ORR is defined as the percentage of participants who achieved partial response (PR) or better (PR, VGPR, CR or sCR) based on computerized algorithm as per IMWG criteria. PR is defined as >=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 FLC levels is required. A >=50% reduction in the size of soft tissue plasmacytomas is also required.

  5. Overall Survival (OS) [ Time Frame: From randomization to death, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years) ]
    OS was measured from the date of randomization to the date of the death.

  6. Time to Disease Progression (TTP) [ Time Frame: From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years) ]
    TTP is defined as the time from the date of randomization to the date of PD based on computerized algorithm as per IMWG criteria, or death due to PD.

  7. Time to Response [ Time Frame: From randomization to first response (PR or better) (up to 7.8 years) ]
    Time to response is defined as the time from the date of randomization to the first efficacy evaluation that met criteria for PR or better based on computerized algorithm as per IMWG criteria. 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 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 PCs is required. A >=50% reduction in the size of soft tissue plasmacytomas is also required.

  8. Duration of Response (DoR) [ Time Frame: From first response (PR of better) to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years) ]
    DoR is defined as the time from the date of initial response (PR or better) to the date of PD, based on computerized algorithm as per IMWG criteria.

  9. Time to Subsequent Anti-myeloma Treatment [ Time Frame: From randomization to start of first subsequent anti-myeloma treatment, death, withdrawal of consent to study participation or CCO whichever is first (up to 7.8 years) ]
    Time to subsequent anti-myeloma treatment is defined as the time from randomization to the start of first line of subsequent anti-myeloma treatment or death, whichever occurs first.

  10. Progression-free Survival on Next Line of Therapy (PFS2) [ Time Frame: From randomization to disease progression on first line of subsequent anti-myeloma therapy, death, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years) ]
    PFS2 is defined as the time from randomization to progression on the first line of subsequent anti-myeloma therapy or death, whichever occurs first. Disease progression on first line of subsequent anti-myeloma treatment was based on investigator judgment. Participants that were censored for PFS1 were also censored for PFS2.

  11. Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 Global Health Status Score to Day 1 of Cycle 3, 6, 9 and 12 [ Time Frame: Baseline and Day 1 of Cycle 3, 6, 9 and 12 (each Cycle of 28 days) ]
    EORTC QLQ-C30 is 30 items self-reporting questionnaire, with 1 week recall period, resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status (GHS) scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Questionnaire includes 28 items with 4-point Likert type responses from "1-not at all" to "4-very much" to assess functioning and symptoms; 2 items with 7-point Likert scales (1= poor and 7= excellent) for global health and overall health related QoL. Scores are transformed to 0 to 100 scale, with higher scores representing better GHS, better functioning, and more symptoms. Negative change from baseline values shows deterioration in quality of life or functioning and reduction in symptom and positive values indicate improvement and worsening of symptoms.

  12. Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) to Day 1 of Cycle 3, 6, 9 and 12 [ Time Frame: Baseline and Day 1 of Cycle 3, 6, 9 and 12 (each Cycle of 28 days) ]
    EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.

  13. Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Utility Score to Day 1 of Cycle 3, 6, 9 and 12 [ Time Frame: Baseline and Day 1 of Cycle 3, 6, 9 and 12 (each Cycle of 28 days) ]
    EQ-5D-5L is standardized, participant-reported questionnaire to assess health-related quality of life. EQ-5D-5L includes 2 components: EQ-5D-5L health state profile (descriptive system) and EQ-5D-5L VAS. EQ-5D-5L descriptive system provides a profile of participant's health state 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. Responses to the 5-dimension scores were combined and converted into single preference-weighted health utility index score 0 (0.0- worst health state) to 1 (1.0- better health state) representing the general health status of individual (but allows for values less than 0 by United kingdom [UK] scoring algorithm).



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:

  • Participant must have documented multiple myeloma satisfying the CRAB (calcium elevation, renal insufficiency, anemia and bone abnormalities) criteria, monoclonal plasma cells in the bone marrow greater than or equal to (>=) 10 percent (%) or presence of a biopsy proven plasmacytoma and measurable disease as defined by any of the following: (a) immunoglobulin (Ig) G myeloma (serum monoclonal paraprotein [M-protein] level >=1.0 gram/deciliter [g/dL] or urine M-protein level >=200 milligram[mg]/24 hours[hrs]; or (b) IgA, IgM, IgD, or IgE multiple myeloma (serum M-protein level >=0.5 g/dL or urine M-protein level >=200 mg/24 hrs); or (c) light chain multiple myeloma without measurable disease in serum or urine (serum immunoglobulin free light chain >=10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio)
  • Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
  • Participants who are newly diagnosed and not considered for high-dose chemotherapy due to: being age >=65 years; or participants less than (<) 65 years with presence of important comorbid condition(s) likely to have a negative impact on tolerability of high dose chemotherapy with stem cell transplantation. Sponsor review and approval of participants below 65 years of age is required before randomization
  • Women of childbearing potential must commit to either abstain continuously from sexual intercourse or to use 2 methods of reliable birth control simultaneously as deemed appropriate by the Investigator. Contraception must begin 4 weeks prior to dosing and must continue for 3 months after the last dose of daratumumab
  • Man, who is sexually active with a woman of child-bearing potential potential must agree to use a latex or synthetic condom, even if he had a successful vasectomy, must agree to use an adequate contraception method as deemed appropriate by the Investigator, and must also agree to not donate sperm during the study and for 4 weeks after last dose of lenalidomide and 4 months after last dose of daratumumab

Exclusion Criteria:

  • Participant has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (presence of serum M-protein <3 g/dL; absence of lytic bone lesions, anemia, hypercalcemia, and renal insufficiency related to the M-protein), or smoldering multiple myeloma (asymptomatic multiple myeloma with absence of related organ or tissue impairment end organ damage)
  • Participant has a diagnosis of Waldenström's disease, or other conditions in which IgM M protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
  • Participant has a history of malignancy (other than multiple myeloma) within 5 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the Investigator, with concurrence with the Sponsor's medical monitor, is considered cured with minimal risk of recurrence within 5 years)
  • Participant has prior or current systemic therapy or SCT for multiple myeloma, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for 4 days) of corticosteroids before treatment
  • Participant has had radiation therapy within 14 days of randomization
  • Participant has known chronic obstructive pulmonary disease (COPD) (defined as a forced expiratory volume in 1 second [FEV1] <50% of predicted normal), persistent asthma, or a history of asthma within the last 2 years (controlled intermittent asthma or controlled mild persistent asthma is allowed)
  • Participants with known or suspected COPD must have a FEV1 test during Screening
  • Participant is known to be seropositive for human immunodeficiency virus (HIV) or hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg] or antibodies to hepatitis B surface and core antigens [anti-HBs and anti-HBc, respectively]) or hepatitis C (anti-HCV antibody positive or HCV-ribonucleic acid [RNA] quantitation positive)

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): NCT02252172


Locations
Hide Hide 215 study locations
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United States, Alabama
Birmingham, Alabama, United States
Mobile, Alabama, United States
United States, Arizona
Glendale, Arizona, United States
United States, California
Berkeley, California, United States
Beverly Hills, California, United States
El Cajon, California, United States
Greenbrae, California, United States
Los Angeles, California, United States
Oceanside, California, United States
San Diego, California, United States
West Hills, California, United States
Whittier, California, United States
United States, Colorado
Denver, Colorado, United States
Fort Collins, Colorado, United States
Glenwood Springs, Colorado, United States
United States, Connecticut
New Haven, Connecticut, United States
Norwalk, Connecticut, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
Boca Raton, Florida, United States
Boynton Beach, Florida, United States
Fort Lauderdale, Florida, United States
Fort Myers, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Lake City, Florida, United States
Saint Petersburg, Florida, United States
Weston, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
Augusta, Georgia, United States
Macon, Georgia, United States
Marietta, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
Niles, Illinois, United States
United States, Indiana
Fort Wayne, Indiana, United States
United States, Iowa
Iowa City, Iowa, United States
United States, Kentucky
Louisville, Kentucky, United States
United States, Louisiana
Lafayette, Louisiana, United States
Marrero, Louisiana, United States
Shreveport, Louisiana, United States
United States, Maryland
Annapolis, Maryland, United States
Baltimore, Maryland, United States
Frederick, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Michigan
Detroit, Michigan, United States
United States, Minnesota
Duluth, Minnesota, United States
Rochester, Minnesota, United States
United States, Missouri
Kansas City, Missouri, United States
Saint Louis, Missouri, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, New Hampshire
Hooksett, New Hampshire, United States
United States, New Jersey
Brick, New Jersey, United States
Hackensack, New Jersey, United States
Livingston, New Jersey, United States
Plainfield, New Jersey, United States
Somerville, New Jersey, United States
Summit, New Jersey, United States
United States, New York
Mineola, New York, United States
New York, New York, United States
Rochester, New York, United States
United States, North Carolina
Asheboro, North Carolina, United States
Charlotte, North Carolina, United States
Pinehurst, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Ohio
Canton, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
United States, Oregon
Bend, Oregon, United States
United States, Pennsylvania
Bethlehem, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Spartanburg, South Carolina, United States
United States, South Dakota
Sioux Falls, South Dakota, United States
United States, Tennessee
Chattanooga, Tennessee, United States
Nashville, Tennessee, United States
United States, Texas
Arlington, Texas, United States
Edinburg, Texas, United States
Fort Sam Houston, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
United States, Utah
Ogden, Utah, United States
United States, Washington
Seattle, Washington, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Australia
Box Hill, Australia
Fitzroy, Australia
Footscray, Australia
Kogarah, Australia
Kurralta Park, Australia
Nedlands, Australia
New South Wales, Australia
Woodville, Australia
Woolloongabba N/a, Australia
Austria
Innsbruck, Austria
Linz, Austria
Salzburg, Austria
Wien N/a, Austria
Wien Wien, Austria
Belgium
Brugge, Belgium
Brussels, Belgium
Brussel, Belgium
Haine-saint-paul, LA Louviere, Belgium
Leuven, Belgium
Liege, Belgium
Canada, Alberta
Calgary, Alberta, Canada
Canada, Ontario
Toronto, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
Montréal, Quebec, Canada
Canada
Greenfield Park, Canada
N/a N/a, Canada
Nova Scotia, Canada
Quebec, Canada
Vancouver, Canada
Denmark
Aarhus C, Denmark
Odense, Denmark
Vejle, Denmark
France
Amiens N/a Picardie, France
Angers, France
Bayonne Cedex, France
Bretagne, France
Caen, France
Cergy Pontoise, France
Chalons Sur Saone, France
Clermont-Ferrand, France
Creteil, France
Dijon, France
Dunkerque Cedex 1, France
Grenoble Cedex 9, France
La Roche sur Yon Cedex 9, France
Le Chesnay Cedex, France
Le Coudray, France
Le Mans, France
Lille Cedex, France
Lille, France
Limoges, France
Lyon, Pierre-Benite, France
Marseille Cedex 9, France
Metz-Tessy, France
Montivilliers, France
Montpellier, France
Mulhouse, France
Nantes, France
Nice N/a, France
Paris Cedex 12, France
Paris, 75, France
Paris, France
PERIGUEUX cedex, France
Perpignan, France
Pessac, France
Poitiers, France
Reims, France
Rennes, France
Rouen Cedex, France
Saint Brieuc Cedex 1, France
Saint Priest en Jarez, France
St Malo Cedex, France
St Quentin Cedex, France
Strasbourg, France
Toulouse Cedex 9, France
TOURS Cedex 9, France
Vandoeuvre Les Nancy, France
Germany
Aschaffenburg, Germany
Bad Berka, Germany
Bonn, Germany
Braunschweig, Germany
Dresden, Germany
Essen, Germany
Frankfurt, Germany
Hannover, Germany
Heidelberg, Germany
Kiel, Germany
Koblenz, Germany
Mainz, Germany
Mannheim, Germany
Rostock, Germany
Schwerin, Germany
Stuttgart, Germany
Tuebingen, Germany
Ulm, Germany
Villingen-Schwenningen, Germany
Ireland
Dublin, Ireland
Galway, Ireland
Israel
Hadera, Israel
Haifa, Israel
Jerusalem, Israel
Nahariya, Israel
Petah Tikva, Israel
Ramat Gan, Israel
Tel-Aviv, Israel
Netherlands
Hilversum, Netherlands
Hoofddorp, Netherlands
Rotterdam, Netherlands
Tilburg, Netherlands
Sweden
Falun, Sweden
Göteborg, Sweden
Halmstad, Sweden
Helsingborg, Sweden
Huddinge, Sweden
Lulea, Sweden
Lund, Sweden
Stockholm, Sweden
Örebro, Sweden
United Kingdom
Aberdeen, United Kingdom
Canterbury, United Kingdom
Dundee, United Kingdom
Leeds, United Kingdom
London, United Kingdom
Manchester, United Kingdom
Nottingham, United Kingdom
Oxford, United Kingdom
Plymouth, Devon, United Kingdom
Southampton, United Kingdom
Truro, United Kingdom
Wf, United Kingdom
Wolverhampton, United Kingdom
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  Study Documents (Full-Text)

Documents provided by Janssen Research & Development, LLC:
Statistical Analysis Plan  [PDF] October 3, 2018
Study Protocol  [PDF] June 12, 2019

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02252172    
Other Study ID Numbers: CR104762
54767414MMY3008 ( Other Identifier: Janssen Research & Development, LLC )
2014-002273-11 ( EudraCT Number )
First Posted: September 30, 2014    Key Record Dates
Results First Posted: January 9, 2020
Last Update Posted: August 25, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janssen Research & Development, LLC:
Multiple Myeloma
Daratumumab
JNJ-54767414
Lenalidomide
Dexamethasone
Additional relevant MeSH terms:
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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
Lenalidomide
Daratumumab
Antibodies, Monoclonal
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
Immunologic Factors