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COMPLETED Phase 2

IV Busulfan Plus Bortezomib Conditioning Regimen for Second Autologous Stem Cell Transplant in Multiple Myeloma Patients

NCT01009840 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 30 participants
Start Date 2010-05
Est. Completion 2012-03
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01009840

The ClinicalTrials.gov registry entry for NCT01009840 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 79 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01009840 reports 13 study locations spanning 11 distinct geographic areas — top geographies include Pennsylvania, Texas, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01009840?

This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 79 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial