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TerminatedNCT00934232Updated May 23, 2017

Busulfan in Multiple Myeloma

A Phase 1 interventional study of Busulfan in Multiple Myeloma, sponsored by Guido Tricot. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-23.

Sponsored by Guido Tricot · Phase 1, Interventional, and Treatment

Why this study was terminated
PI left the institution
Phase
Phase 1
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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.

Read the detailed description

This study is for first line treatment for multiple myeloma patients in patients >65 years or have renal insufficiency Busulfan introduces cytopenia much slower than melphalan while the time to recover after transplantation is the same. The duration of cytopenia with busulfan should therefore be shorter. Busulfan given in myeloma patients with renal failure has proven to be effective.

The initial proposed dose level in our study will be 3.2mg/kg of body weight over 6 hours for 3 days. The next levels will be 3.2mg/kg of body weight over 6 hours for 4 days, 4.3 mg/kg of body weight over 6 hours for 3 days, 5.6 mg/kg of body weight over 6 hours for 2 days, and 6.4 mg/kg of body weight over 6 hours for 2 days. Three patients per group will be entered at the first level. Further enrollment will be dependent upon toxicities observed. All dose escalations will be initiated after the PI has reviewed the toxicity data available on the prior dose levels and confirms that it is safe to proceed to subsequent dose level(s). Maximum tolerated dose will defined as the dose level immediately below the dose level at which ≥ 2 of 6 patients experiences a grade 4 non-hematological toxicity that is unexpected, related, and serious, and it will be evaluated separately for patients > 65 years of age or in patients with renal insufficiency.

02

Conditions studied

  • Multiple Myeloma

Keywords

  • cancer
  • myeloma
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 13 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Guido Tricot is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Subjects must have ≥ 3 x 106 CD34 cell/kg in storage for this study.
  2. Subjects must have symptomatic multiple myeloma at their new patient consult at HCI that, in the opinion of the enrolling physician, requires treatment.
  3. 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.
  4. 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).
  5. Subjects must demonstrate adequate cardiac function (≥40% LVEF on ECHO or MUGA).
  6. 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)
  7. 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.
  8. Subjects must have a SWOG performance score of 0-2 unless due to myeloma-related bone pain.
  9. 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.
  10. Female participants of child-bearing potential must have a negative pregnancy test documented within 10 days of enrollment.

Exclusion criteria

Exclusion Criteria:

  1. 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)
  2. 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.
  3. 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.
  4. Subjects must not have had a prior autologous or allogeneic bone marrow transplant.
  5. 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.
  6. Patients who have \< 3 million CD34 cells/kg stored for this protocol.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    Busulfan

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

    Drug: Busulfan

Interventions

  • DrugBusulfan

    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 ®

06

What researchers measure

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.

    Time frame: 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.

    Time frame: 18 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00934232
Lead sponsor
Guido Tricot
Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Responsible party
Guido Tricot (Guido J.K. Tricot, MD, PhD, University of Iowa) — Sponsor-investigator
First posted
Jul 8, 2009
Start date
Aug 2009
Primary completion
Feb 2012
Completion
Feb 2012
Last update
May 23, 2017

Study contacts

Guido Tricot, MD, PhD
principal investigator · University of Iowa

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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