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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Muneer Abidi, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00288028
First received: February 6, 2006
Last updated: November 18, 2013
Last verified: November 2013
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • Maximum tolerated dose [ Time Frame: At course 8 ] [ Designated as safety issue: Yes ]
  • Safety and tolerability [ Time Frame: At course 8 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall response rate by Southwest Oncology Group (SWOG) criteria [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At day 30 following stem cell transplant and following course 4, course 8, and 1 year of study treatment ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: July 2005
Study Completion Date: June 2012
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bortezomib
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
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
Other Name: Velcade®

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Study Chair: Muneer H. Abidi, MD Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Muneer Abidi, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00288028     History of Changes
Other Study ID Numbers: CDR0000455585, P30CA022453, WSU-D-2957, WSU-0506002467
Study First Received: February 6, 2006
Last Updated: November 18, 2013
Health Authority: United States: Federal Government

Keywords provided by Barbara Ann Karmanos Cancer Institute:
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
refractory multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
Bortezomib
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014