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NCT01009840 · ClinicalTrials.gov registry record · Phase 2
IV Busulfan Plus Bortezomib Conditioning Regimen for Second Autologous Stem Cell Transplant in Multiple Myeloma Patients
A Phase 2 study of Multiple Myeloma, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 13
- Study locations
NCT01009840: Completed Phase 2 study of Multiple Myeloma, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT01009840 is a Phase 2 study of Multiple Myeloma that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 30 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (95% lower). The trial reports 13 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01009840, a Phase 2 study of Multiple Myeloma, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 13
- Study locations
Study Summary
Study for the outcome and safety of individualized busulfan dosing with bortezomib for patients preparing for a second stem cell transplant to treat multiple myeloma.
Primary Outcome
The percentage of participants reported in each disease category by International Myeloma Working Group (IMWG) uniform response criteria for Multiple Myeloma 6 months after autologous Hematopoietic stem cell transplant. Overall Disease Response categories were: \[stringent Complete Response (sCR)=CR + normal Free Light Chain (FLC) ratio + absence of clonal cells in bone marrow\], \[Complete Response (CR)=Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacy
Conditions Studied
Interventions
- DRUG bortezomib
- DRUG IV busulfan
- PROCEDURE Autologous Hematopoietic Stem Cell Transplant (HSCT)
Study Locations (13)
Pennsylvania
- University of Pennsylvania -Abramson Cancer Center - Philadelphia
- The Western Pennsylvania Hospital - Pittsburgh
Texas
- South Texas Veterans Health Care System - San Antonio
- Texas Transplant Physician Group, PLLC - San Antonio
Arizona
- Arizona Cancer Center - Tucson
Georgia
- Blood and Marrow Transplant Group of Georgia - Atlanta
Illinois
- Loyola University Medical Center - Maywood
Indiana
- Indiana University Melvin and Bren Simon Cancer Center - Indianapolis
Maryland
- University of Maryland School of Medicine - Marlene & Stewart Greenebaum Cancer Center - Baltimore
Michigan
- Karmanos Cancer Institute - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2010-05 |
| Est. Completion | 2012-03 |
| Phase | Phase 2 |
What the finished NCT01009840 record still lists
NCT01009840 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 3 interventions - of which bortezomib is the first listed.
NCT01009840 lists 13 locations in 11 states (Pennsylvania, Texas, Arizona).
Frequently Asked Questions
What is clinical trial NCT01009840 about?
NCT01009840 is a clinical study titled "IV Busulfan Plus Bortezomib Conditioning Regimen for Second Autologous Stem Cell Transplant in Multiple Myeloma Patients". Study for the outcome and safety of individualized busulfan dosing with bortezomib for patients preparing for a second stem cell transplant to treat multiple myeloma.
What is the current status of trial NCT01009840?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2010-05. Estimated completion is 2012-03.
What conditions does trial NCT01009840 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT01009840?
The interventions under investigation include: bortezomib (DRUG), IV busulfan (DRUG), Autologous Hematopoietic Stem Cell Transplant (HSCT) (PROCEDURE).
Who is sponsoring clinical trial NCT01009840?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01009840 being conducted?
This trial has 13 study locations across Arizona, Georgia, Illinois, Indiana, Maryland. 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 NCT01009840's enrollment target sits among peer trials
30 338th of 438 higher than 80 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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