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

NCT00288028 | Completed Phase 1

• 4 other identifiers: CDR0000455585P30CA022453WSU-D-2957WSU-0506002467
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose

  At course 8

• Safety and tolerability

  At course 8

Secondary Outcomes (3)

• 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

• 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

• Response duration by SWOG criteria

  At day 30 following stem cell transplant and following course 4, course 8, and 1 year of study treatment

Study Arms (1)

Bortezomib

EXPERIMENTAL

Bortezomib is administered as a 5 second IV bolus on days 1, 4, 8,11 or 1,8 and 15 of a 21-35 days cycle (Depending on the Dosing schedule). The dosage will be calculated based on actual weight of the patient unless the actual weight is greater than 40% above the ideal body weight. In this instance the dosage will be based on the adjusted ideal body weight. The Adjusted IBW (kg) = IBW + 0.25 x (actual body weight - IBW). The dosage will be adjusted based on the safety and toxicity profile, until a MTD is determined.

Drug: bortezomib

Interventions

bortezomib DRUG

Dose of Bortezomib\* Level 1: 1.3 mg/m2 on Day 1, 4, 8, 11 - Every 21 days; Level 2: 1.3 mg/m2 on Day 1, 4, 8, 11 - Every 28 days; Level 3: 1.0 mg/m2 on Day 1, 8, 15 - Every 28 days; Level 4: 1.0 mg/m2 on Day 1, 8, 15 - Every 35 days

Also known as: Velcade®

Bortezomib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Bortezomib

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)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Muneer H. Abidi, MD

  Barbara Ann Karmanos Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 6, 2006
• First Posted: February 7, 2006
• Study Start: July 1, 2005
• Primary Completion: November 1, 2010
• Study Completion: June 1, 2012
• Last Updated: November 19, 2013

Record last verified: 2013-11

Locations

US (1)