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UARK 2003-25: A Study of Intravenous (IV) Busulfan (Busulfex®) in Multiple Myeloma Patients

Information source: University of Arkansas
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Myeloma

Intervention: Busulfan (Drug)

Phase: Phase 1/Phase 2

Status: Terminated

Sponsored by: University of Arkansas

Official(s) and/or principal investigator(s):
Frits van Rhee, MD, PhD, Principal Investigator, Affiliation: UAMS

Summary

The purpose of this study is to find out if patients with high risk disease because of age or kidney status can be treated more safely with a drug called Busulfex® followed by autologous transplant compared to treatment with the standard drug called melphalan, which has been shown to be quite difficult to tolerate in patients with poor kidney function and patients over the age of 65 when given in high doses.

Clinical Details

Official title: 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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome: Response Rate (CR, NCR) and Overall Survival of Patients on Busulfex Treatment

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States

University of Arkansas for Medical Sciences, Myeloma Institute for Research and Therapy, Little Rock, Arkansas 72205, United States

Additional Information

Starting date: June 2004
Last updated: April 10, 2015

Page last updated: August 23, 2015

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