Bortezomib in Treating Patients With Multiple Myeloma Who Have Undergone an Autologous Peripheral Blood Stem Cell Transplant - Full Text View

Sponsors and Collaborators:	Barbara Ann Karmanos Cancer Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00288028

Purpose

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving bortezomib after an autologous peripheral blood stem cell transplant may stop the growth of any cancer cells that remain after transplant.

PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib in treating patients with multiple myeloma who have undergone an autologous peripheral blood stem cell transplant.

Condition	Intervention	Phase
Multiple Myeloma and Plasma Cell Neoplasm	Drug: bortezomib	Phase I

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Bortezomib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase I Study of Bortezomib During Maintenance Phase After High Dose Melphalan and Autologous Stem Cell Transplantation in Patients With Multiple Myeloma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Maximum tolerated dose at course 8 [ Designated as safety issue: Yes ]
Safety and tolerability at course 8 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Overall response rate by Southwest Oncology Group (SWOG) criteria at day 30 following stem cell transplant and following course 4, course 8, and 1 year of study treatment [ Designated as safety issue: No ]
Complete response rate by SWOG criteria at day 30 following stem cell transplant and following course 4, course 8, and 1 year of study treatment [ Designated as safety issue: No ]
Response duration by SWOG criteria at day 30 following stem cell transplant and following course 4, course 8, and 1 year of study treatment [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	July 2005
Estimated Primary Completion Date:	July 2019 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00288028

Locations

United States, Michigan
Barbara Ann Karmanos Cancer Institute	Recruiting
Detroit, Michigan, United States, 48201-1379
Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute 313-576-9363
Sinai-Grace Hospital	Recruiting
Detroit, Michigan, United States, 48235
Contact: Muneer Abidi 313-576-8713

Sponsors and Collaborators

Barbara Ann Karmanos Cancer Institute

National Cancer Institute (NCI)

Investigators

Study Chair:

Muneer H. Abidi, MD

Barbara Ann Karmanos Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000455585, WSU-D-2957, WSU-0506002467
Study First Received:	February 6, 2006
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00288028 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
refractory multiple myeloma

Study placed in the following topic categories:

Melphalan
Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Bortezomib
Vascular Diseases

Paraproteinemias
Hemostatic Disorders
Protease Inhibitors
Multiple Myeloma
Hemorrhagic Disorders
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Blood Protein Disorders
Hematologic Diseases
Bortezomib
Vascular Diseases
Enzyme Inhibitors
Paraproteinemias

Hemostatic Disorders
Pharmacologic Actions
Protease Inhibitors
Multiple Myeloma
Neoplasms
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on May 07, 2009