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
Last Update Posted
: January 31, 2017
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Sponsor:
Biotest Pharmaceuticals Corporation
Collaborator:
Biotest
Information provided by (Responsible Party):
Biotest Pharmaceuticals Corporation
Tracking Information | ||||
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First Submitted Date ICMJE | October 22, 2009 | |||
First Posted Date ICMJE | October 26, 2009 | |||
Last Update Posted Date | January 31, 2017 | |||
Study Start Date ICMJE | August 2010 | |||
Actual Primary Completion Date | July 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01001442 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Safety and Dose Determining Multi-dose Study of BT062 in Patients With Relapsed or Refractory Multiple Myeloma | |||
Official Title ICMJE | A Phase I/IIa Multi-Dose Escalation Study to Evaluate Maximum Tolerated Dose (MTD), Pharmacokinetics (PK), Safety and Efficacy of BT062 in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma | |||
Brief Summary | This Phase I/IIa clinical study is to test safety and anti-tumor activity of BT062 to define the best dose in treating patients with relapsed or refractory multiple myeloma with multiple doses of BT062. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 Phase 2 |
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Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Multiple Myeloma | |||
Intervention ICMJE | Drug: BT062
intravenous administration |
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Study Arms | Experimental: BT062
Intervention: Drug: BT062 |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
35 | |||
Original Estimated Enrollment ICMJE |
80 | |||
Actual Study Completion Date | March 2016 | |||
Actual Primary Completion Date | July 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01001442 | |||
Other Study ID Numbers ICMJE | 975 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Biotest Pharmaceuticals Corporation | |||
Study Sponsor ICMJE | Biotest Pharmaceuticals Corporation | |||
Collaborators ICMJE | Biotest | |||
Investigators ICMJE |
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PRS Account | Biotest Pharmaceuticals Corporation | |||
Verification Date | August 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |