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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
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
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

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
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).
Total Total of all reporting groups

Baseline Measures
   Lenalidomide, Low-dose Dexamethasone (Rd)   Daratumumab, Lenalidomide, Dexamethasone (DRd)   Total 
Overall Participants Analyzed 
[Units: Participants]
 283   286   569 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.3  (8.84)   64.4  (9.03)   64.4  (8.93) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      119  42.0%      113  39.5%      232  40.8% 
Male      164  58.0%      173  60.5%      337  59.2% 
Region of Enrollment 
[Units: Participants]
     
Australia   9   9   18 
Belgium   10   12   22 
Canada   17   17   34 
Denmark   7   10   17 
France   36   21   57 
Germany   7   11   18 
Greece   8   11   19 
Israel   20   19   39 
Japan   15   21   36 
Korea, Republic of   20   20   40 
Netherlands   3   1   4 
Poland   13   15   28 
Russian Federation   30   18   48 
Spain   25   26   51 
Sweden   15   16   31 
Taiwan, Province of China   9   11   20 
United Kingdom   24   27   51 
United States   15   21   36 
Stage of Disease (ISS) [1] 
[Units: Participants]
     
 140   137   277 
II   86   93   179 
III   57   56   113 
[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]
     
 146   149   295 
 80   85   165 
 38   38   76 
>3   19   14   33 


  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

Time Frame No text entered.
Additional Description Safety Population included participants who were randomized and received at least 1 dose of any study treatment.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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).

Other Adverse Events
    Lenalidomide, Low-dose Dexamethasone (Rd)   Daratumumab, Lenalidomide, Dexamethasone (DRd)
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   274/281 (97.51%)   276/283 (97.53%) 
Blood and lymphatic system disorders     
Anaemia * 1     
# participants affected / at risk   98/281 (34.88%)   87/283 (30.74%) 
Leukopenia * 1     
# participants affected / at risk   17/281 (6.05%)   21/283 (7.42%) 
Lymphopenia * 1     
# participants affected / at risk   15/281 (5.34%)   17/283 (6.01%) 
Neutropenia * 1     
# participants affected / at risk   121/281 (43.06%)   168/283 (59.36%) 
Thrombocytopenia * 1     
# participants affected / at risk   77/281 (27.40%)   76/283 (26.86%) 
Eye disorders     
Cataract * 1     
# participants affected / at risk   8/281 (2.85%)   18/283 (6.36%) 
Vision Blurred * 1     
# participants affected / at risk   14/281 (4.98%)   19/283 (6.71%) 
Gastrointestinal disorders     
Abdominal Pain * 1     
# participants affected / at risk   11/281 (3.91%)   20/283 (7.07%) 
Abdominal Pain Upper * 1     
# participants affected / at risk   10/281 (3.56%)   21/283 (7.42%) 
Constipation * 1     
# participants affected / at risk   71/281 (25.27%)   82/283 (28.98%) 
Diarrhoea * 1     
# participants affected / at risk   65/281 (23.13%)   121/283 (42.76%) 
Dyspepsia * 1     
# participants affected / at risk   6/281 (2.14%)   18/283 (6.36%) 
Nausea * 1     
# participants affected / at risk   40/281 (14.23%)   67/283 (23.67%) 
Stomatitis * 1     
# participants affected / at risk   6/281 (2.14%)   17/283 (6.01%) 
Vomiting * 1     
# participants affected / at risk   14/281 (4.98%)   46/283 (16.25%) 
General disorders     
Asthenia * 1     
# participants affected / at risk   36/281 (12.81%)   45/283 (15.90%) 
Chills * 1     
# participants affected / at risk   9/281 (3.20%)   17/283 (6.01%) 
Fatigue * 1     
# participants affected / at risk   78/281 (27.76%)   100/283 (35.34%) 
Influenza Like Illness * 1     
# participants affected / at risk   12/281 (4.27%)   17/283 (6.01%) 
Oedema Peripheral * 1     
# participants affected / at risk   37/281 (13.17%)   43/283 (15.19%) 
Pyrexia * 1     
# participants affected / at risk   30/281 (10.68%)   53/283 (18.73%) 
Infections and infestations     
Bronchitis * 1     
# participants affected / at risk   31/281 (11.03%)   36/283 (12.72%) 
Nasopharyngitis * 1     
# participants affected / at risk   43/281 (15.30%)   68/283 (24.03%) 
Pneumonia * 1     
# participants affected / at risk   17/281 (6.05%)   20/283 (7.07%) 
Respiratory Tract Infection * 1     
# participants affected / at risk   22/281 (7.83%)   28/283 (9.89%) 
Rhinitis * 1     
# participants affected / at risk   3/281 (1.07%)   15/283 (5.30%) 
Sinusitis * 1     
# participants affected / at risk   10/281 (3.56%)   18/283 (6.36%) 
Upper Respiratory Tract Infection * 1     
# participants affected / at risk   54/281 (19.22%)   89/283 (31.45%) 
Investigations     
Alanine Aminotransferase Increased * 1     
# participants affected / at risk   10/281 (3.56%)   15/283 (5.30%) 
Weight Decreased * 1     
# participants affected / at risk   9/281 (3.20%)   16/283 (5.65%) 
Metabolism and nutrition disorders     
Decreased Appetite * 1     
# participants affected / at risk   28/281 (9.96%)   32/283 (11.31%) 
Hyperglycaemia * 1     
# participants affected / at risk   19/281 (6.76%)   25/283 (8.83%) 
Hypocalcaemia * 1     
# participants affected / at risk   11/281 (3.91%)   17/283 (6.01%) 
Hypokalaemia * 1     
# participants affected / at risk   22/281 (7.83%)   30/283 (10.60%) 
Hypophosphataemia * 1     
# participants affected / at risk   11/281 (3.91%)   16/283 (5.65%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1     
# participants affected / at risk   21/281 (7.47%)   24/283 (8.48%) 
Back Pain * 1     
# participants affected / at risk   45/281 (16.01%)   49/283 (17.31%) 
Bone Pain * 1     
# participants affected / at risk   12/281 (4.27%)   17/283 (6.01%) 
Muscle Spasms * 1     
# participants affected / at risk   52/281 (18.51%)   73/283 (25.80%) 
Muscular Weakness * 1     
# participants affected / at risk   21/281 (7.47%)   23/283 (8.13%) 
Musculoskeletal Chest Pain * 1     
# participants affected / at risk   17/281 (6.05%)   15/283 (5.30%) 
Musculoskeletal Pain * 1     
# participants affected / at risk   15/281 (5.34%)   17/283 (6.01%) 
Myalgia * 1     
# participants affected / at risk   9/281 (3.20%)   16/283 (5.65%) 
Pain in Extremity * 1     
# participants affected / at risk   30/281 (10.68%)   20/283 (7.07%) 
Nervous system disorders     
Dizziness * 1     
# participants affected / at risk   24/281 (8.54%)   22/283 (7.77%) 
Dysgeusia * 1     
# participants affected / at risk   15/281 (5.34%)   21/283 (7.42%) 
Headache * 1     
# participants affected / at risk   19/281 (6.76%)   37/283 (13.07%) 
Neuropathy Peripheral * 1     
# participants affected / at risk   15/281 (5.34%)   12/283 (4.24%) 
Peripheral Sensory Neuropathy * 1     
# participants affected / at risk   18/281 (6.41%)   23/283 (8.13%) 
Tremor * 1     
# participants affected / at risk   24/281 (8.54%)   26/283 (9.19%) 
Psychiatric disorders     
Anxiety * 1     
# participants affected / at risk   12/281 (4.27%)   18/283 (6.36%) 
Depression * 1     
# participants affected / at risk   5/281 (1.78%)   17/283 (6.01%) 
Insomnia * 1     
# participants affected / at risk   55/281 (19.57%)   55/283 (19.43%) 
Renal and urinary disorders     
Renal Impairment * 1     
# participants affected / at risk   13/281 (4.63%)   20/283 (7.07%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1     
# participants affected / at risk   35/281 (12.46%)   82/283 (28.98%) 
Dyspnoea * 1     
# participants affected / at risk   32/281 (11.39%)   51/283 (18.02%) 
Skin and subcutaneous tissue disorders     
Hyperhidrosis * 1     
# participants affected / at risk   8/281 (2.85%)   20/283 (7.07%) 
Pruritus * 1     
# participants affected / at risk   29/281 (10.32%)   28/283 (9.89%) 
Rash * 1     
# participants affected / at risk   29/281 (10.32%)   35/283 (12.37%) 
Vascular disorders     
Hypertension * 1     
# participants affected / at risk   7/281 (2.49%)   20/283 (7.07%) 
Hypotension * 1     
# participants affected / at risk   6/281 (2.14%)   19/283 (6.71%) 
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA Version 18.0



  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: 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