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Safety and Dose Determining Multi-dose Study of BT062 in Patients With Relapsed or Refractory Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT01001442
Recruitment Status : Completed
First Posted : October 26, 2009
Results First Posted : May 8, 2018
Last Update Posted : May 8, 2018
Sponsor:
Collaborator:
Biotest
Information provided by (Responsible Party):
Biotest Pharmaceuticals Corporation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Multiple Myeloma
Intervention: Drug: BT062

  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
The Intention-to-treat (ITT) population included all subjects who were enrolled in the study and received at least 1 dose of BT062 and who had any post-Baseline evaluations or data. One subject did not have at least one post-injection assessment of the treatment response and was excluded from both the ITT and PP populations (n = 34).

Reporting Groups
  Description
BT062 40 mg/m² 40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 50 mg/m² 50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 65 mg/m² 65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 80 mg/m² 80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 100 mg/m² 100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 120 mg/m² 120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 140 mg/m² 140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 160 mg/m² 160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.

Participant Flow:   Overall Study
    BT062 40 mg/m²   BT062 50 mg/m²   BT062 65 mg/m²   BT062 80 mg/m²   BT062 100 mg/m²   BT062 120 mg/m²   BT062 140 mg/m²   BT062 160 mg/m²
STARTED   4   3   4   3   4   3   10   4 
COMPLETED   4   3   4   3   2   3   6   2 
NOT COMPLETED   0   0   0   0   2   0   4   2 



  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.
ITT: The Intention-to-treat (ITT) population included all subjects who were enrolled in the study and received at least 1 dose of BT062 and who had any post-Baseline evaluations or data. One subject did not have at least one post-injection assessment of the treatment response and was excluded from both the ITT and PP populations (n = 34).

Reporting Groups
  Description
BT062 40 mg/m² 40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 50 mg/m² 50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 65 mg/m² 65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 80 mg/m² 80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 100 mg/m² 100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 120 mg/m² 120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 140 mg/m² 140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 160 mg/m² 160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
Total Total of all reporting groups

Baseline Measures
   BT062 40 mg/m²   BT062 50 mg/m²   BT062 65 mg/m²   BT062 80 mg/m²   BT062 100 mg/m²   BT062 120 mg/m²   BT062 140 mg/m²   BT062 160 mg/m²   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   3   4   3   3   3   10   4   34 
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%      0   0.0% 
Between 18 and 65 years      1  25.0%      3 100.0%      2  50.0%      2  66.7%      1  33.3%      3 100.0%      2  20.0%      3  75.0%      17  50.0% 
>=65 years      3  75.0%      0   0.0%      2  50.0%      1  33.3%      2  66.7%      0   0.0%      8  80.0%      1  25.0%      17  50.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 70.3  (15.56)   55.3  (7.64)   64.3  (9.39)   60.7  (4.51)   64.3  (8.02)   55.3  (5.03)   66.8  (8.80)   61.5  (9.98)   63.5  (9.63) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
                 
Female      2  50.0%      3 100.0%      2  50.0%      1  33.3%      2  66.7%      1  33.3%      5  50.0%      2  50.0%      18  52.9% 
Male      2  50.0%      0   0.0%      2  50.0%      2  66.7%      1  33.3%      2  66.7%      5  50.0%      2  50.0%      16  47.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
                 
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      1  10.0%      1  25.0%      2   5.9% 
Not Hispanic or Latino      4 100.0%      3 100.0%      3  75.0%      3 100.0%      3 100.0%      3 100.0%      9  90.0%      3  75.0%      31  91.2% 
Unknown or Not Reported      0   0.0%      0   0.0%      1  25.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      1   2.9% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
                 
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0%      0   0.0%      1  33.3%      1  33.3%      4  40.0%      1  25.0%      7  20.6% 
White      4 100.0%      3 100.0%      3  75.0%      3 100.0%      2  66.7%      2  66.7%      6  60.0%      3  75.0%      26  76.5% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      1  25.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      1   2.9% 
Region of Enrollment 
[Units: Participants]
                 
United States   4   3   4   3   3   3   10   4   34 


  Outcome Measures

1.  Primary:   Dose Limiting Toxicities (DLT) - Number of Participants With at Least 1 DLT   [ Time Frame: Starting with first study drug administration until 30-day follow-up visit (average 4.99 months) ]

2.  Primary:   Maximum Tolerated Dose (MTD)   [ Time Frame: First 28-day cycle ]

3.  Secondary:   Qualitative and Quantitative Toxicities of BT062   [ Time Frame: Starting with first study drug administration until 30-day follow-up visit (average 4.99 months) ]

4.  Secondary:   Multi-dose Pharmacokinetics Properties of BT062 - Cmax   [ Time Frame: Starting with first study drug administration until 30-day follow-up visit (average 4.99 months). ]

5.  Secondary:   Anti-tumor Activity of BT062 in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma by Number of Participants With Objective Response(ORR) and/or Clinial Benefit(CBR) Based on the International Myeloma Working Group Uniform Response Criteria   [ Time Frame: On day 1 of each treatment cycle (on a monthly basis) starting with first study drug administration until Close Out visit (average 3.84 months). ]

6.  Secondary:   Time to Progression (TTP), Progression Free Survival (PFS) and Overall Survival (OS)   [ Time Frame: Starting with first study drug administration until death or 3 years from first study treatment. ]


  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: Iris Bobenhausen
Organization: Biotest AG
phone: +49 6103 801 ext 4832
e-mail: iris.bobenhausen@biotest.com



Responsible Party: Biotest Pharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT01001442     History of Changes
Other Study ID Numbers: 975
First Submitted: October 22, 2009
First Posted: October 26, 2009
Results First Submitted: January 3, 2018
Results First Posted: May 8, 2018
Last Update Posted: May 8, 2018