Phase 2
Completed N=30
Adjuvant Bortezomib Maintenance Therapy After Autologous Peripheral Stem Cell Transplantation in Treating Patients With Intermediate or Advanced Multiple Myeloma
Source: ClinicalTrials.gov NCT00084747 ↗Enrolled (actual)
30
Serious AEs
6.7%
Results posted
Mar 2016
Primary outcomePrimary: Progression-free Survival — 29 months
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
29 | — |
| SECONDARY Overall Survival |
55 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00084747). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.