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UARK 2003-25: A Phase I/II Open Label Study of IV Busulfan (Busulfex®) in Multiple Myeloma Patients Older Than 65 Years of Age or With Renal Insufficiency


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

UARK 2003-25: A Phase I/II Open Label Study of IV Busulfan (Busulfex®) in Multiple Myeloma Patients Older Than 65 Years of Age or With Renal Insufficiency


This trial will determine the maximal dose of Busulfex® that can be given in a two, three,
or four day period with acceptable toxicity to myeloma patients, who either are > or = 65
years of age or have renal insufficiency, defined as creatinine > 3g/dL or creatinine
clearance < 30 ml/min.


Inclusion Criteria:



- Patients must have symptomatic multiple myeloma requiring treatment

- Patients must have been approved for single or tandem autologous transplant

- Patients must be > or = 65 years of age or diagnosed with renal insufficiency,
defined as having a creatinine > 3 mg/dl or a creatinine clearance < 30 ml/minute

- Patients must not have a history of chronic obstructive or chronic restrictive
pulmonary disease. Patients must have adequate pulmonary function studies > 50% of
predicted on mechanical aspects (FEV1, FVC, etc) and diffusion capacity (DLCO) > 50%
of predicted,

- Patients must have an ECHO or MUGA performed within 60 days prior to registration,
LVEF > 40%.

- Bilirubin, SGOT, SGPT must be less than 1.5 times the upper limit of normal

- Patients must have evaluable myeloma marker for response such as: *Serum M protein
>1g/dl or urine M protein >1g/24 hours and/or; *Bone marrow plasmacytosis with >20%
plasma cells and/or; *Extramedullary plasmacytosis; *MRI/PET scan has focal lesions
due to myeloma.

- Patients must be able to receive full doses of DT-PACE, in the opinion of the
treating investigator, with the exception of cisplatin.

- Patients must have a performance status of 0-2 based on SWOG criteria unless the
patient's status is due to active myeloma

- All patients must be informed of the investigational nature of the study and have
signed an IRB-approved informed consent in accordance with institutional and federal
guidelines.

Exclusion Criteria:

- Serum transaminases > 1.5 x ULN and direct bilirubin > 1.5 mg/dl

- HIV positive or active Hepatitis B or Hepatitis C infection; (if serology is positive
a quantitative PCR will be done).

- Patients with a prior malignancy in whom life expectancy is more likely to be
determined by the prior malignancy than the myeloma. Patients must not currently be
receiving therapy for the prior malignancy.

- Pregnant or nursing women. Women of childbearing potential must have a negative
pregnancy test documented within one week of registration. Women/men of reproductive
potential may not participate unless they have agreed to use an effective
contraceptive method.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximal Dose of Busulfex® Given in a 2, 3, or 4 Day Period With Acceptable Toxicity to Myeloma Patients

Outcome Description:

maximal dose of Busulfex® that can be given in a two, three, or four day period with acceptable toxicity to myeloma patients, who either are > or = 65 years of age or have renal insufficiency, defined as creatinine > 3g/dL or creatinine clearance < 30 ml/min

Outcome Time Frame:

three years

Safety Issue:

Yes

Principal Investigator

Frits van Rhee, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UAMS

Authority:

United States: Institutional Review Board

Study ID:

2003-25

NCT ID:

NCT00113919

Start Date:

June 2004

Completion Date:

October 2009

Related Keywords:

  • Multiple Myeloma
  • Myeloma, MM
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Renal Insufficiency

Name

Location

University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
University of Arkansas for Medical Sciences, Myeloma Institute for Research and TherapyLittle Rock, Arkansas  72205