Adjuvant Bortezomib Maintenance Therapy After Autologous Peripheral Stem Cell Transplantation in Treating Patients With Intermediate or Advanced Multiple Myeloma
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Giving bortezomib as maintenance therapy after autologous stem cell transplantation may kill more cancer cells and prolong remission.
PURPOSE: This phase I/II trial is studying the side effects and best dose of adjuvant bortezomib as maintenance therapy and to see how well it works in treating patients who have undergone stem cell transplantation for intermediate or advanced multiple myeloma.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma and Plasma Cell Neoplasm |
Drug: bortezomib Procedure: adjuvant therapy |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I/II Trial of Autologous Peripheral Blood Progenitor Cell Transplantation With VELCADE Maintenance as Treatment for Intermediate- and Advanced-Stage Multiple Myeloma |
- Progression-free and overall survival [ Designated as safety issue: No ]
- Disease progression rate [ Designated as safety issue: No ]
- Mortality rate [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | June 2004 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 69 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 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
- SGOT or 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
Contacts and Locations| United States, California | |
| Jonsson Comprehensive Cancer Center at UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Principal Investigator: | Gary J. Schiller, MD | Jonsson Comprehensive Cancer Center |
More Information
Additional Information:
Publications:
| Responsible Party: | Jonsson Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00084747 History of Changes |
| Other Study ID Numbers: | CDR0000365583, P30CA016042, UCLA-0306106, MILLENNIUM-MM2003 |
| Study First Received: | June 10, 2004 |
| Last Updated: | August 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Jonsson Comprehensive Cancer Center:
|
stage II multiple myeloma stage III multiple myeloma |
Additional relevant MeSH terms:
|
Neoplasms Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Neoplasms by Histologic Type Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders |
Immunoproliferative Disorders Immune System Diseases Adjuvants, Immunologic Bortezomib Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013