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Daratumumab (HuMax®-CD38) Safety Study in Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT00574288
Recruitment Status : Completed
First Posted : December 17, 2007
Results First Posted : March 9, 2017
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Drug: Part 1: Daratumumab
Drug: Part 2: Daratumumab
Other: Methylprednisolone
Other: 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
Part 1 - <4 mg/kg Participants were administered with 7 full intravenous (IV) infusion of 0.005, 0.05, 0.1, 0.5, 1 and 2 milligram per kilogram body weight (mg/kg) daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
Part 1 - 4 mg/kg Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
Part 1 - 8 mg/kg Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
Part 1 - 16 mg/kg Participants were administered with 7 full IV infusion of 16 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
Part 1 - 24 mg/kg Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
Part 2 - 8 mg/kg Participants were administered with 8 full IV infusions of 8 mg/kg daratumumab once weekly for 8 weeks, then every 2 weeks (q2w) for 16 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions.
Part 2 - 16 mg/kg Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 weeks (q2w) for 14 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.

Participant Flow:   Overall Study
    Part 1 - <4 mg/kg   Part 1 - 4 mg/kg   Part 1 - 8 mg/kg   Part 1 - 16 mg/kg   Part 1 - 24 mg/kg   Part 2 - 8 mg/kg   Part 2 - 16 mg/kg
STARTED   20   3   3   3   3   30   42 
COMPLETED   0   0   0   1   1   4   14 
NOT COMPLETED   20   3   3   2   2   26   28 
Adverse Event                2                0                0                0                1                0                0 
Death                0                0                0                0                0                25                21 
Lost to Follow-up                0                0                0                0                0                1                2 
Study Terminated By Sponsor                0                0                0                0                0                0                5 
Progressive Disease                17                2                3                2                1                0                0 
Other                1                1                0                0                0                0                0 



  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
Part 1 - <4 mg/kg Participants were administered with 7 full intravenous (IV) infusion of 0.005, 0.05, 0.1, 0.5, 1 and 2 milligram per kilogram body weight (mg/kg) daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
Part 1 - 4 mg/kg Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
Part 1 - 8 mg/kg Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
Part 1 - 16 mg/kg Participants were administered with 7 full IV infusion of 16 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
Part 1 - 24 mg/kg Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
Part 2 - 8 mg/kg Participants were administered with 8 full IV infusions of 8 mg/kg daratumumab once weekly for 8 weeks, then every 2 weeks (q2w) for 16 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions.
Part 2 - 16 mg/kg Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 weeks (q2w) for 14 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
Total Total of all reporting groups

Baseline Measures
   Part 1 - <4 mg/kg   Part 1 - 4 mg/kg   Part 1 - 8 mg/kg   Part 1 - 16 mg/kg   Part 1 - 24 mg/kg   Part 2 - 8 mg/kg   Part 2 - 16 mg/kg   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   3   3   3   3   30   42   104 
Age 
[Units: Participants]
Count of Participants
               
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      11  55.0%      2  66.7%      2  66.7%      3 100.0%      2  66.7%      21  70.0%      22  52.4%      63  60.6% 
>=65 years      9  45.0%      1  33.3%      1  33.3%      0   0.0%      1  33.3%      9  30.0%      20  47.6%      41  39.4% 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.8  (9.24)   64  (2)   61.3  (6.11)   53  (1.73)   59  (9.54)   58.6  (10.05)   63.8  (8.27)   61.4  (9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
               
Female      7  35.0%      2  66.7%      0   0.0%      0   0.0%      0   0.0%      9  30.0%      15  35.7%      33  31.7% 
Male      13  65.0%      1  33.3%      3 100.0%      3 100.0%      3 100.0%      21  70.0%      27  64.3%      71  68.3% 
Region of Enrollment 
[Units: Participants]
Count of Participants
               
Denmark   11   1   2   2   0   5   9   30 
Netherlands   4   2   1   1   2   14   8   32 
Sweden   5   0   0   0   1   5   11   22 
United States   0   0   0   0   0   6   14   20 
No. of Prior Lines of Therapy 
[Units: Participants]
Count of Participants
               
<= 3 Lines      2  10.0%      2  66.7%      0   0.0%      0   0.0%      0   0.0%      6  20.0%      16  38.1%      26  25.0% 
> 3 Lines      18  90.0%      1  33.3%      3 100.0%      3 100.0%      3 100.0%      24  80.0%      26  61.9%      78  75.0% 
Refractory to proteasome inhibitor (PI)/immunomodulatory agent (IMiD) 
[Units: Participants]
Count of Participants
               
Both a PI and IMiD      0   0.0%      2  66.7%      3 100.0%      1  33.3%      2  66.7%      19  63.3%      27  64.3%      54  51.9% 
PI only      0   0.0%      1  33.3%      0   0.0%      0   0.0%      0   0.0%      2   6.7%      3   7.1%      6   5.8% 
IMiD only      0   0.0%      0   0.0%      0   0.0%      1  33.3%      1  33.3%      6  20.0%      4   9.5%      12  11.5% 
None      20 100.0%      0   0.0%      0   0.0%      1  33.3%      0   0.0%      3  10.0%      8  19.0%      32  30.8% 


  Outcome Measures

1.  Primary:   Number of Participants With Adverse Events   [ Time Frame: Up to Week 28 (for Part 1) and up to approximately 2.5 years (for Part 2) ]

2.  Secondary:   Overall Response Rate   [ Time Frame: Up to Week 28 (for Part 1) and Week 27 (for Part 2) ]

3.  Secondary:   Part 1: Time to Response   [ Time Frame: Up to Week 28 ]

4.  Secondary:   Part 2: Time to Progression (TTP)   [ Time Frame: Up to Week 27 ]

5.  Secondary:   Part 2: Duration of Response as Assessed Using the Method of Kaplan-Meier   [ Time Frame: Up to Week 27 ]

6.  Secondary:   Part 2: Progression-Free Survival   [ Time Frame: Up to Week 27 ]

7.  Secondary:   Part 2: Time to Response   [ Time Frame: Up to Week 27 ]

8.  Secondary:   Part 2: Overall Survival   [ Time Frame: Approximately 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: Senior Director
Organization: Janssen Research & Development, LLC
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: NCT00574288     History of Changes
Other Study ID Numbers: CR101876
GEN501 ( Other Identifier: Janssen Research & Development, LLC )
DARA-GEN501 ( Other Identifier: Janssen Research & Development, LLC )
2007-003783-22 ( EudraCT Number )
First Submitted: December 14, 2007
First Posted: December 17, 2007
Results First Submitted: October 21, 2016
Results First Posted: March 9, 2017
Last Update Posted: April 27, 2018