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Busulfan in Multiple Myeloma

NCT00934232 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2017-05-23

No results posted yet for this study

Summary

Two main objectives of the study are:

Primary:

To determine the MTD of Busulfex ® that can be given safely over the least number of days to myeloma patients who are either ≥65 years of age (Group 1) or have renal insufficiency (Group 2), defined as creatinine \>3mg/dL or creatinine clearance \<30 mL/min.

Secondary:

To perform pharmacokinetic (PK) studies to evaluate individual variability and the relationship to toxicities in each of the two groups at each proposed dose level.

Conditions

Interventions

DRUG

Busulfan

Busulfan (Bu) is a bifunctional alkylating agent currently used almost exclusively as a component of conditioning regimens for both autologous and allogeneic stem-cell transplants.

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    collaborator INDUSTRY

  • Guido Tricot

    lead OTHER

Principal Investigators

  • Guido Tricot, MD, PhD · University of Iowa

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2012-02-29
Completion
2012-02-29

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00934232 on ClinicalTrials.gov