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

NCT00113919 | Terminated Phase 1 Results DMC

• 1 other identifier: 2003-25
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Multiple Myeloma

Keywords

Myeloma, MM

Outcome Measures

Primary Outcomes (1)

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

  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

  three years

Study Arms (1)

Busulfan

EXPERIMENTAL

study-specific treatment: Busulfex according to study design: Level I 3.2 mg/kg over 6 hours x 2 days Level II 3.2 mg/kg over 6 hours x 3 days Level III 3.2 mg/kg over 6 hours x 4 days Level IV 4.3 mg/kg over 6 hours x 3 days Level V 5.6 mg/kg over 6 hours x 2 days Level VI 6.4 mg/kg over 6 hours x 2 days

Drug: Busulfan

Interventions

Busulfan DRUG

Dexamethasone 40 mg PO 1-4 Thalidomide 200 mg PO 1-6 Cisplatin\* 10 mg/m, Continuous infusion 1-4 Adriamycin\*\* 10 mg/m2, Continuous infusion 1-4 Cyclophosphamide 400 mg/2, Continuous infusion 1-4 Etoposide 40 mg/m2, Continuous infusion 1-4 All doses will be based on calculated body weight (actual weight + ideal body weight ÷ 2) and height, and not to exceed a BSA of 2.0 m2 The daily dose of cyclophosphamide, etoposide, and cisplatin will be mixed in a 1L bag of NS to be UAMS infused over 24 hours. Adriamycin will be mixed in at least 50cc D5W to be infused over 24 hours

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:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (2)

University of Arkansas for Medical Sciences, Myeloma Institute for Research and Therapy

Little Rock, Arkansas, 72205, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Busulfan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; 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

Limitations and Caveats

Early termination, only 5 of the 14 completed, reasons as follows: Death Unrelated to Protocol Adverse Event Relapse Patient Choice

Results Point of Contact

• Title: Nathan Petty
• Organization: University of Arkansas for Medical Sciences

pettynathanm@uams.edu

501-837-3894

Study Officials

• Frits van Rhee, MD, PhD

  UAMS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2005
• First Posted: June 13, 2005
• Study Start: June 1, 2004
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: October 16, 2017
• Results First Posted: June 20, 2011

Record last verified: 2017-09

Locations

US (2)