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Trial record 1 of 1 for:    mmy3003
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A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory 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: NCT02076009
Recruitment Status : Active, not recruiting
First Posted : March 3, 2014
Results First Posted : February 10, 2017
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Drug: Daratumumab
Drug: Lenalidomide
Drug: Dexamethasone

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Lenalidomide, Low-dose Dexamethasone (Rd) Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
Daratumumab, Lenalidomide, Dexamethasone (DRd) Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).

Participant Flow:   Overall Study
    Lenalidomide, Low-dose Dexamethasone (Rd)   Daratumumab, Lenalidomide, Dexamethasone (DRd)
STARTED   283   286 
Treated   281   283 
COMPLETED   0   0 
NOT COMPLETED   283   286 
Death                44                30 
Withdrawal by Subject                9                3 
Lost to Follow-up                1                1 
Progressive disease                1                0 
Ongoing                226                249 
Subjects randomized but not treated                2                3 



  Baseline Characteristics


  Outcome Measures

1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: From randomization to either disease progression or death whichever occurs first until 3 years ]

2.  Secondary:   Time to Disease Progression (TTP)   [ Time Frame: From randomization to disease progression until 3 years ]

3.  Secondary:   Percentage of Participants Who Achieved Very Good Partial Response (VGPR) or Better   [ Time Frame: From randomization to disease progression (approximately up to 3 years) ]

4.  Secondary:   Percentage of Participants With Negative Minimal Residual Disease (MRD)   [ Time Frame: From randomization to the date of first documented evidence of PD until 3 years ]

5.  Secondary:   Overall Response Rate   [ Time Frame: From randomization to disease progression (approximately up to 3 years) ]

6.  Secondary:   Overall Survival (OS)   [ Time Frame: Up to approximately 5 years (anticipated) after the last participant is randomized ]

7.  Secondary:   Time to Response   [ Time Frame: From randomization up to first documented CR or PR until 3 years ]

8.  Secondary:   Duration of Response (DOR)   [ Time Frame: From randomization to the date of first documented evidence of PD until 3 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Director, Clinical Research
Organization: Janssen R&D US
e-mail: ClinicalTrialDisclosure@its.jnj.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02076009     History of Changes
Other Study ID Numbers: CR103663
54767414MMY3003 ( Other Identifier: Janssen Research & Development, LLC )
2013-005525-23 ( EudraCT Number )
First Submitted: February 27, 2014
First Posted: March 3, 2014
Results First Submitted: December 20, 2016
Results First Posted: February 10, 2017
Last Update Posted: July 28, 2017