A phase II trial of PAD (Bortezomib, Doxorubicin and Dexamethasone) induction therapy in transplant-eligible patients with untreated multiple myeloma (MM), stratified for markers of bortezomib resistance.

Phase 2

Completed

• Conditions: Multiple Myeloma; Cancer - Myeloma

• Registration Number: ACTRN12609000296235
• Lead Sponsor: Janssen-Cilag Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-18
• Study Completion: 2011-11-25
• Last Update Posted: 22 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

Previously diagnosed with multiple myeloma; eligible for autologous stem cell transplantation; meets pre-treatment lab criteria (as defined within protocol).

Exclusion Criteria

Previously received treatment for multiple myeloma (including prior therapy with radiation or pulsed dexamethasone), except localised radiation to a solitary lesion or plasmacytomas or 4 days of corticosteroid therapy; have a current diagnosis of smoldering multiple myeloma, monoclonal gammopathy of undetermined significance (MGUS), or Waldenstrom Macroglobulinemia; have a history of any other malignancy within 5 years before enrolment; have other significant comorbidities

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the overall response rate following 4 cycles of PAD induction therapy between patients with and without amplification of 1q21 (measured by FISH - Fluorescence In Situ Hybridization ) in their marrow at baseline. Overall response will be measured by a number of factors including M-protein changes, clinical examination, radiological images, bone marrow results and IMWG (International Myeloma Working Group) Uniform Disease Response Criteria.[Disease response assessed monthly for 1 year after first treatment.]

Secondary Outcome Measures

Name	Time	Method
To compare the overall response rate to PAD induction therapy 3-months following ASCT (Autologous Stem Cell Transplantation), between patients with and without amplification of 1q21[3-months following ASCT.];To determine the event-free survival and overall survival rate at 2 years after Day 1 Cycle 1 of PAD.[2 years after Day 1 Cycle 1 of PAD];To determine the effect on overall response rate and overall survival of protein expression of p53, p16, Cyclin D1, bcl2, FGFR3 (Fibroblast growth factor receptor 3) (measured by immunohistochemistry)[At PAD completion and 3-months following ASCT.];To assess quality of life of patients treated with PAD[At each study visit. There are a total of 15 study visits, performed at: Screening, Day 1 of each Cycle, PBSC (Peripheral Blood Stem Cell) Collection and ASCT visits; then at monthly intervals to 1 year after first treatment; and finally at 2 years after first treatment.]