Busulfan in Multiple Myeloma

NCT00934232 | Terminated Phase 1 DMC

• 1 other identifier: 32857
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief 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

Multiple Myeloma

Keywords

cancer; myeloma

Outcome Measures

Primary Outcomes (1)

• determine MTD of Busulfex given safely over least number of days patients who are either ≥65 years Group 1) or have renal insufficiency (Group 2), defined as creatinine >3mg/dL or creatinine clearance <30 mL/min.

  1 year

Secondary Outcomes (1)

• 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.

  18 months

Study Arms (1)

Busulfan

EXPERIMENTAL

Busulfex given to patients who are either ≥65 years or have renal insufficiency

Drug: Busulfan

Interventions

Busulfan DRUG

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.

Also known as: Busulfex ®

Busulfan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have ≥ 3 x 106 CD34 cell/kg in storage for this study.
• Subjects must have symptomatic multiple myeloma at their new patient consult at HCI that, in the opinion of the enrolling physician, requires treatment.
• Subjects must be at least 65 years of age and/or diagnosed with renal insufficiency, defined as serum creatinine ≥3mg/dL or a creatinine clearance of less than 30mL/minute.
• Subjects must not have a history of chronic obstructive or chronic restrictive pulmonary disease. Subjects must demonstrate adequate pulmonary function studies defined as ≥50% of predicted on mechanical aspects (FEV1, FVC) and diffusion capacity (DLCO).
• Subjects must demonstrate adequate cardiac function (≥40% LVEF on ECHO or MUGA).
• Subjects must demonstrate adequate liver functions with total bilirubin and transaminase levels no higher than 1.5 times the institutional upper limit of normal. (If total bilirubin is \> 1.5 times the upper limit of normal, a direct bilirubin needs to be assessed. Subject eligible as long as the direct bilirubin is not \> 1.5 times the upper limit of normal)
• Subjects must have at least one evaluable myeloma marker by which to judge response: serum M protein \>1g/dL, free light chains in the serum that more than four times the upper limit of normal, urine M protein of ≥ 500 mg, urine free light chains of ≥ 500 mg/day, bone marrow plasmacytosis with \>20% plasma cells, extramedullary plasmacytosis, or MRI/FDG-PET/CT scan demonstrating 1 or more focal lesions due to myeloma.
• Subjects must have a SWOG performance score of 0-2 unless due to myeloma-related bone pain.
• Subjects must be informed of the investigational nature of the study and must sign an IRB-approved informed consent in accordance with institutional and federal guidelines.
• Female participants of child-bearing potential must have a negative pregnancy test documented within 10 days of enrollment.

You may not qualify if:

• Subjects must not have serum transaminases \>1.5 times the upper limit of normal and/or a direct bilirubin \>1.5 time the institutional upper limit of normal (direct bilirubin to be assessed only if the total bilirubin is \> 1.5 times the upper limit of normal)
• Subjects must not be HIV positive or have active Hepatitis B or Hepatitis C infection. If serology antibody studies are positive, a quantitative PCR must be done to confirm.
• Subjects must not have a prior malignancy in which life expectancy, which in the opinion of the investigator, is more likely to be determined by the prior malignancy than the myeloma. Patients must not be currently receiving therapy for the prior malignancy.
• Subjects must not have had a prior autologous or allogeneic bone marrow transplant.
• Subjects must not be pregnant or nursing. Women and men of reproductive potential may not participate unless they agree to use an effective contraceptive method.
• Patients who have \< 3 million CD34 cells/kg stored for this protocol.

Sponsors & Collaborators

• Guido Tricot: lead
• Otsuka Pharmaceutical Development & Commercialization, Inc.: collaborator

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms; Neoplasms, Plasma Cell

Interventions

Busulfan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Guido Tricot, MD, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Guido J.K. Tricot, MD, PhD

Study Record Dates

• First Submitted: June 4, 2009
• First Posted: July 8, 2009
• Study Start: August 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: May 23, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share