A Phase I Study of Bortezomib During Maintenance Phase After High Dose Melphalan and Autologous Stem Cell Transplantation in Patients With Multiple Myeloma
18 Years
N/A
Both
Multiple Myeloma and Plasma Cell Neoplasm
Trial Information
A Phase I Study of Bortezomib During Maintenance Phase After High Dose Melphalan and Autologous Stem Cell Transplantation in Patients With Multiple Myeloma
OBJECTIVES:
Primary
- Determine the maximum tolerated dose (MTD) of bortezomib during maintenance phase after
high-dose melphalan and autologous peripheral blood stem cell transplantation in
patients with multiple myeloma.
- Determine the safety and tolerability of bortezomib in these patients.
Secondary
- Determine the overall response rate, complete response rate, and response duration in
patients treated with bortezomib at the MTD.
OUTLINE: This is an open-label, dose-finding study.
Patients receive bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 21 or 28
days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive de-escalating doses of bortezomib (at varying dosing
schedules) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the
dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At
least 6 patients are treated at the MTD.
After completion of study treatment, patients are followed at 1 year.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of multiple myeloma
- Must have completed high-dose melphalan and autologous peripheral blood stem cell
transplantation
- Transplant must have been completed 30-120 days ago
- Must not be receiving maintenance therapy
- Patients must have received 200 mg/m² of melphalan intravenously as a
conditioning regimen (no dose reduction allowed)
- No evidence of amyloidosis
- No available donor
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
- Absolute neutrophil count > 1,500/mm^3
- Platelet count > 75,000/mm^3
- Bilirubin ≤ 1.5 times upper limit of normal
- Transaminase ≤ 3 times upper limit of normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Must have a negative HIV test
- No baseline neurological disease > grade I
- No cranial nerve palsy
- No demonstrated resistance to bortezomib
- No history of allergic reactions attributed to bortezomib, boron, or mannitol
- No cardiac arrhythmia
- No unstable angina pectoris
- No symptomatic congestive heart failure
- No ongoing or active infection
- No other uncontrolled illness
- No psychiatric illness or social situations that would limit compliance with study
requirements
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No other concurrent anticancer therapies or agents
- No other concurrent investigational agents
- Not receiving maintenance therapy after prior stem cell transplantation on another
clinical trial
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose
Outcome Time Frame:
At course 8
Safety Issue:
Yes
Principal Investigator
Muneer H. Abidi, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Barbara Ann Karmanos Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000455585
NCT ID:
NCT00288028
Start Date:
July 2005
Completion Date:
June 2012
Related Keywords:
- Multiple Myeloma and Plasma Cell Neoplasm
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- refractory multiple myeloma
- Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
Name | Location |
|---|---|
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
