Phase I/II Trial of Autologous Peripheral Blood Progenitor Cell Transplantation With VELCADE Maintenance as Treatment for Intermediate- and Advanced-Stage Multiple Myeloma
bortezomib
Blood Protein Disorders+12
+ Cardiovascular Diseases
+ Hematologic Diseases
Treatment Study
Summary
Study start date: June 1, 2004
Actual date on which the first participant was enrolled.OBJECTIVES: * Determine response rate, as defined by resolution of bone marrow plasmacytosis and monoclonal paraproteinemia, in the first year after autologous peripheral blood stem cell transplantation in patients with intermediate or advanced multiple myeloma treated with adjuvant bortezomib. * Compare progression-free survival of patients treated with adjuvant bortezomib with historical controls treated with autologous transplantation alone. * Determine the toxicity of this drug in these patients (phase I). OUTLINE: This is a multicenter, dose-escalation study. Patients receive bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of bortezomib 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. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 2 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 69 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Diagnosis of intermediate or advanced multiple myeloma meeting criteria for at least 1 2 following: * Intermediate- to high-M-component production rates (immunoglobulin \[Ig\]G \> 5 g/dL or immunoglobulin A (IgA) \> 3 g/dL or urine M component \> 4 g/24 hours) * More than one osteolytic bone lesion or radiographic evidence of diffuse osteoporosis * β-2 microglobulin \> 3 * Nonsecretory myeloma if bone marrow plasmacytosis is greater than 30% * Must have undergone autologous peripheral blood stem cell transplantation within the past 3-4 months * Age 18 to 69 years old * Absolute neutrophil count ≥ 1,000/mm\^3 * Platelet count ≥ 30,000/mm\^3 * serum glutamate oxaloacetate transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) ≤ 300 IU * Bilirubin ≤ 2 mg/dL * Creatinine ≤ 2.0 mg/dL * Creatinine clearance ≥ 30 mL/min * Negative pregnancy test * Fertile patients must use effective contraception Exclusion Criteria: * concurrent major cardiac disease that would preclude study participation * concurrent major pulmonary disease that would preclude study participation * pregnant or nursing * peripheral neuropathy ≥ grade 2 * history of hypersensitivity to bortezomib, boron, or mannitol * concurrent major gastrointestinal or bladder disease that would preclude study participation * concurrent major neurologic or psychiatric disease that would preclude study participation * dementia or significantly altered mental status that would preclude giving informed consent * prior interferon post-transplantation * prior thalidomide post-transplantation * prior chemotherapy post-transplantation * prior radiotherapy post-transplantation * prior investigational therapy post-transplantation * prior bortezomib * prior therapy for myeloma post-transplantation * other concurrent anti-myeloma therapy * other concurrent investigational therapy
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location