Know Cancer

or
forgot password

A Phase I Study of Bortezomib During Maintenance Phase After High Dose Melphalan and Autologous Stem Cell Transplantation in Patients With Multiple Myeloma


Phase 1
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma and Plasma Cell Neoplasm

Thank you

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 InstituteDetroit, Michigan  48201