At a glance
ClinicalIndex Comparison Record- ✓Primary refractory multiple myeloma (failed to achieve partial response after first-line induction therapy) OR plasma cell leukemia (newly diagnosed or previously treated)
- ✓Age ≥18 years
- ✓Histologically confirmed diagnosis by pathologic review at the H. Lee Moffitt Cancer Center and Research Institute
- ✓Completed psychosocial evaluation and deemed capable of compliance
- ✕Platelet count <30 × 10⁹/L within 14 days before enrollment
- ✕Absolute neutrophil count <1.0 × 10⁹/L within 14 days before enrollment
- ✕Serum creatinine >2.0 mg/dL OR creatinine clearance <40 mL/min within 14 days before enrollment
- ✕Grade >2 peripheral neuropathy within 14 days before enrollment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Evaluation of Bortezomib (VelcadeR ) Followed by High-Dose Melphalan and Bortezomib (VelcadeR) as Conditioning Regimen for Tandem Peripheral Blood Stem Cell Transplants in Patients With Primary Refractory Multiple Myeloma and Plasma Cell Leukemia
In Brief
A Phase 2 clinical trial evaluating Bortezomib, Melphalan, and 1 other intervention for Multiple Myeloma and Plasma Cell Leukemia. Completed, enrolled 30 participants across 1 site.
Detailed Summary
The primary objectives of this study are to: * To determine the maximum tolerated dose (MTD) of bortezomib in combination with high-dose melphalan as a conditioning regimen. * To determine the safety, tolerability, and response rates of bortezomib given in combination with high-dose melphalan, as a conditioning regimen, for tandem transplants in patients with primary refractory multiple myeloma or plasma cell leukemia. The secondary objectives of this study are to: * To determine gene expression profiles (pharmacogenomics) and perform RTPCR for Fanconi anemia pathway genes, prior to and after treatment with bortezomib, in patients with primary refractory multiple myeloma and plasma cell leukemia and correlate profiles with responses to treatment. * To determine the time to disease progression and overall survival in patients with primary refractory multiple myeloma and plasma cell leukemia treated with bortezomib followed by tandem autologous transplantation * To determine the response rates of 2 cycles of bortezomib in patients with primary refractory multiple myeloma or plasma cell leukemia
Study Details
Timeline
Interventions
the maximum tolerated dose (MTD) of bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous stem cell transplant
Day -4 melphalan 100 mg/m2 intravenously over 30 minutes, Day -3 melphalan 100 mg/m2 intravenously over 30 minutes
PBSCT #1 Day 0 PBSCT #2 Day 0 (approx 90 days =/- 15 days after PBSCT #1)