Under 70, any sex, with Multiple Myeloma and Plasma Cell Neoplasm or Neurotoxicity. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Adverse EventsPrimary· After 4 months of maintenance therapy
All grade 3 and above treatment-related adverse events (AEs) during bortezomib/dexamethasone treatment cycles.
One Year Overall SurvivalPrimary· From date of treatment initiation until death from any cause, assessed up to one year.
One year overall survival estimated using the product-limit method of Kaplan and Meier. Defined as the percentage of patients alive at year one after starting treatment.
Count of Response in Patients Started on Maintenance TherapySecondary· Post-Thalidomide at 1 year.
Complete Response (CR): Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow.
Very Good Partial Response (VGPR): Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \< 100mg per 24-h.
Partial Response (PR): \> 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by \> 90% or to \< 200mg per 24-h In addition to the above listed criteria, if present at baseline, a . 50% reduction in the siz
One Year Progression-free Survival (PFS)Secondary· From start of treatment initiation until disease progression, relapse or death from any cause, assessed up to 1 year.
PFS estimated using the product-limit method of Kaplan and Meier. Defined as the percentage of patients progression-free at year one after starting treatment.
International Myeloma Working Group uniform response criteria for disease progression:
Increase of \> 25% from baseline in Serum M-component and/or (the absolute increase must be \> 0.5 g/dl); Urine M-component and/or (the absolute increase must be \> 200 mg/24 h; Only in patients without measurable serum and urine M-protein levels:
the difference between involved and uninvolved FLC levels. The absolute increase must be \>l0mg/dl.
Bo
Time frame: Adverse events were collected over a period of 3 years and 11 months..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
RATIONALE: Bortezomib and thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Bortezomib may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving bortezomib together with thalidomide and dexamethasone may kill any cancer cells that remain after high-dose melphalan and stem cell transplant in patients with multiple myeloma.
PURPOSE: This phase II trial is studying the side effects of giving bortezomib together with thalidomide and dexamethasone after melphalan and stem cell transplant and to see how well it works in treating patients with stage I-III multiple myeloma.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Other recruiting trials for Multiple Myeloma and Plasma Cell Neoplasm
Currently open trials in the same condition.
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Trials by the same sponsor.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by City of Hope Medical Center
Last refreshed: 19 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00792142.