ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    mmy3004
Previous Study | Return to List | Next Study

Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With 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: NCT02136134
Recruitment Status : Active, not recruiting
First Posted : May 12, 2014
Results First Posted : February 10, 2017
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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: VELCADE (Bortezomib)
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Bortezomib + Dexamethasone (Vd) Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
Daratumumab + Bortezomib and Dexamethasone (DVd) Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.

Participant Flow:   Overall Study
    Bortezomib + Dexamethasone (Vd)   Daratumumab + Bortezomib and Dexamethasone (DVd)
STARTED   247   251 
Treated   237   243 
COMPLETED   0   0 
NOT COMPLETED   247   251 
Death                35                29 
Withdrawal by Subject                14                4 
Other                3                3 
Ongoing                185                207 
Subjects randomized but not treated                10                8 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Bortezomib + Dexamethasone (Vd) Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
Daratumumab + Bortezomib and Dexamethasone (DVd) Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
Total Total of all reporting groups

Baseline Measures
   Bortezomib + Dexamethasone (Vd)   Daratumumab + Bortezomib and Dexamethasone (DVd)   Total 
Overall Participants Analyzed 
[Units: Participants]
 247   251   498 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.9  (9.81)   62.8  (9.66)   63.3  (9.74) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      100  40.5%      114  45.4%      214  43.0% 
Male      147  59.5%      137  54.6%      284  57.0% 
Region of Enrollment 
[Units: Participants]
     
Australia   20   23   43 
Brazil   9   13   22 
Czech Republic   19   16   35 
Germany   21   21   42 
Hungary   14   16   30 
Italy   25   24   49 
Korea, Republic of   8   10   18 
Mexico   1   2   3 
Netherlands   14   11   25 
Poland   18   16   34 
Russian Federation   13   21   34 
Spain   19   10   29 
Sweden   9   10   19 
Turkey   14   14   28 
Ukraine   22   28   50 
United States   21   16   37 
Stage of Disease (ISS) [1] 
[Units: Participants]
     
 96   98   194 
II   100   94   194 
III   51   59   110 
[1] The International Staging System (ISS) consists of following 3 stages - Stage I: serum beta2-microglobulin less than (<)3.5 milligram per liter (mg/l) and albumin greater than or equal to (>=) 3.5 gram per 100 Milliliter (g/100 ml); Stage II: neither stage I nor stage III and Stage III: serum beta2-microglobulin >= 5.5 mg/l.
No. of Prior Lines of Therapy 
[Units: Participants]
     
 113   122   235 
 74   70   144 
 32   37   69 
>3   28   22   50 


  Outcome Measures

1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: From the date of randomization to either progressive disease or death, whichever occurs first (approximately 3 years) ]

2.  Secondary:   Time to Disease Progression (TTP)   [ Time Frame: From the date of randomization to the date of first documented evidence of progression or death due to PD whichever occurs first (approximately 3 years) ]

3.  Secondary:   Percentage of Participants With a Very Good Partial Response (VGPR) or Better   [ Time Frame: Up to disease progression (approximately of 3 years) ]

4.  Secondary:   Overall Response Rate (ORR)   [ Time Frame: Up to disease progression (approximately of 3 years) ]

5.  Secondary:   Percentage of Participants With Negative Minimal Residual Disease (MRD)   [ Time Frame: Up to disease progression (approximately of 3 years) ]

6.  Secondary:   Overall Survival (OS)   [ Time Frame: Up to the end of the study (approximately of 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
No text entered.


  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: NCT02136134     History of Changes
Obsolete Identifiers: NCT01620879
Other Study ID Numbers: CR103995
2014-000255-85 ( EudraCT Number )
54767414MMY3004 ( Other Identifier: Janssen Research & Development, LLC )
First Submitted: May 1, 2014
First Posted: May 12, 2014
Results First Submitted: December 20, 2016
Results First Posted: February 10, 2017
Last Update Posted: September 24, 2018