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NCT01638936 · ClinicalTrials.gov registry record · Phase 1
BT062 in Combination With Lenalidomide or Pomalidomide and Dexamethasone in Patients With Multiple Myeloma
A Phase 1 study of Multiple Myeloma, sponsored by Biotest Pharmaceuticals Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
- 10
- Study locations
NCT01638936: Completed Phase 1 study of Multiple Myeloma, sponsored by Biotest Pharmaceuticals Corporation.
NCT01638936 is a Phase 1 study of Multiple Myeloma that has completed, run by Biotest Pharmaceuticals Corporation. The registered enrollment target is 64 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (88% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01638936, a Phase 1 study of Multiple Myeloma, has completed, sponsored by Biotest Pharmaceuticals Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
- 10
- Study locations
Study Summary
The purpose of this study is to test safety and anti-tumor activity of BT062 in combination with lenalidomide and dexamethasone to define the best doses for treating patients with relapsed and refractory multiple myeloma.
Primary Outcome
The Phase I part will follow a standard dose escalation design with at least 3 patients per dose level to define optimal dose of BT062 in combination with lenalidomide/dexamethasone. Optimal dose will be defined by dose limiting toxicities (DLT) observed during Cycle 1 (28 days).
Conditions Studied
Interventions
- DRUG BT062 , intravenous administration
Study Locations (10)
California
- City of Hope - Duarte
- USC Norris Comprehensive Cancer Center - Los Angeles
Florida
- Mayo Clinic - Jacksonville
- Memorial Healthcare System - Pembroke Pines
Georgia
- Emory University Winship Cancer Institute - Atlanta
Illinois
- The University of Chicago - Chicago
Massachusetts
- Dana-Farber Cancer Institute - Boston
New Jersey
- Hackensack University Medical Center - Hackensack
New York
- Mount Sinai Medical Center - New York
Texas
- University of Texas Health Science Center - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2012-07-03 |
| Est. Completion | 2018-10-30 |
| Phase | Phase 1 |
What the finished NCT01638936 record still lists
NCT01638936 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 1 intervention - of which BT062 , intravenous administration is the first listed.
NCT01638936 lists 10 locations in 8 states (California, Florida, Georgia).
Frequently Asked Questions
What is clinical trial NCT01638936 about?
NCT01638936 is a clinical study titled "BT062 in Combination With Lenalidomide or Pomalidomide and Dexamethasone in Patients With Multiple Myeloma". The purpose of this study is to test safety and anti-tumor activity of BT062 in combination with lenalidomide and dexamethasone to define the best doses for treating patients with relapsed and refractory multiple myeloma.
What is the current status of trial NCT01638936?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2012-07-03. Estimated completion is 2018-10-30.
What conditions does trial NCT01638936 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT01638936?
The interventions under investigation include: BT062 , intravenous administration (DRUG).
Who is sponsoring clinical trial NCT01638936?
This trial is sponsored by Biotest Pharmaceuticals Corporation, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01638936 being conducted?
This trial has 10 study locations across California, Florida, Georgia, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01638936's enrollment target sits among peer trials
64 223rd of 438 higher than 216 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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