Multiple Myeloma Clinical Trial
Official title:
A Phase II Trial of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction Therapy in Patients With Untreated Multiple Myeloma (MM), Stratified for Markers of Bortezomib Resistance
The purpose of this study is to determine efficacy of treatment with bortezomib (in combination with doxorubicin and dexamethasone) in previously untreated patients with Multiple Myeloma.
Status | Completed |
Enrollment | 107 |
Est. completion date | November 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 Waldenström Macroglobulinemia - have a history of any other malignancy within 5 years before enrolment - have other significant comorbidities. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Janssen-Cilag Pty Ltd |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Response Rate (ORR): Number of Participants Who Are Responders (Had Stringent Complete Response [sCR], CR, Very Good Partial Response [VGPR] or Partial Response [PR]) After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction | International Myeloma Working Group (IMWG) criteria - CR: negative immunofixation on the serum and urine, no soft tissue plasmacytomas and <5% plasma cells in the bone marrow; sCR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR: serum and urine M-protein detected by immunofixation but not electrophoresis, >90% in serum M-protein+urine, M-protein level <100 mg/24hour; PR: =50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by =90% or <200 mg/24hour | 84 days | No |
Secondary | Disease Response After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction | Number of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR) and stable disease (SD). | 84 days | No |
Secondary | Overall Response Rate (ORR) to Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction 3-months Following Autologous Stem Cell Transplant (ASCT). | Responders are the number of participants who achieved stringent complete response (sCR)/ complete response (CR), very good partial response (VGPR) or partial response (PR) following PAD induction. | 3-months following ASCT | No |
Secondary | Disease Response 3-months After Autologous Stem Cell Transplant (ASCT) | Number of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), stable disease (SD) and relapse as per IMWG criteria. | 3-months after ASCT | No |
Secondary | Event Free Survival (EFS) | Percentage of participants who did not have any of the following events: Death, Disease progression, Relapse, Cardiovascular accidents, Deep vein thrombosis, Pulmonary embolism, Fracture, Acute renal failure, Nervous system disorders 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD). | 2 years after Day 1 Cycle 1 of PAD | No |
Secondary | Overall Survival | Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD). | 2 years after Day 1 Cycle 1 of PAD | No |
Secondary | Assessment of Quality of Life (AQoL) Scores | The AQoL is a multi-attribute utility health-related quality of life (HRQoL) instrument. It combines the 4 dimensions of independent living, relationships, senses and mental health into a single utility score. The AQoL instrument scores between 1 (best HRQoL) and -0.04 (worst possible HRQoL). | Up to 2 years | No |
Secondary | Overall Response Rate (ORR) Stratified by Protein Expression (p53) | Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (p53). | 84 days | No |
Secondary | Overall Response Rate (ORR) Stratified by Protein Expression (Cyclin D1). | Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (Cyclin D1). | 84 days | No |
Secondary | Overall Response Rate (ORR) Stratified by Protein Expression (Bcl-2) | Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (bcl-2) | 84 days | No |
Secondary | Overall Response Rate (ORR) Stratified by Protein Expression (FGFR3) | Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (FGFR3) | 84 days | No |
Secondary | Overall Survival (OS) Stratified by Protein Expression (p53). | Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD) stratified by protein expression (p53). | 2 years after Day 1 Cycle 1 of PAD | No |
Secondary | Overall Survival (OS) Stratified by Protein Expression (Cyclin D1) | Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD) stratified by protein expression (Cyclin D1). | 2 years after Day 1 Cycle 1 of PAD | No |
Secondary | Overall Survival (OS) Stratified by Protein Expression (Bcl-2) | Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD) stratified by protein expression (bcl-2). | 2 years after Day 1 Cycle 1 of PAD | No |
Secondary | Overall Survival (OS) Stratified by Protein Expression (FGFR3) | Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD) stratified by protein expression (FGFR3). | 2 years after Day 1 Cycle 1 of PAD | No |
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