Phase 2
Completed N=107
A Study of Efficacy of Treatment With Bortezomib (in Combination With Doxorubicin and Dexamethasone) in Previously Untreated Patients With Multiple Myeloma
Source: ClinicalTrials.gov NCT00872521 ↗Enrolled (actual)
107
Serious AEs
46.7%
Results posted
May 2013
Primary outcomePrimary: 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 — 8; 0; 1; 9 Participants — p=0.09
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
8; 0; 1; 9; 55; 20 | 0.09 |
| SECONDARY Disease Response After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction |
5; 3; 1; 9; 6; 3 | 0.23 |
| SECONDARY Overall Response Rate (ORR) to Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction 3-months Following Autologous Stem Cell Transplant (ASCT). |
4; 0; 0; 4; 54; 20 | 0.23 |
| SECONDARY Disease Response 3-months After Autologous Stem Cell Transplant (ASCT) |
6; 5; 3; 14; 8; 3 | 0.56 |
| SECONDARY Event Free Survival (EFS) |
75.0; 69.6 | 0.01 sig |
| SECONDARY Overall Survival |
93.8; 86.4 | 0.28 |
| SECONDARY Assessment of Quality of Life (AQoL) Scores |
0.0516596; 0.0068695; 0.1267145; 0.0480281 | — |
| SECONDARY Overall Response Rate (ORR) Stratified by Protein Expression (p53) |
14; 3; 61; 11 | — |
| SECONDARY Overall Response Rate (ORR) Stratified by Protein Expression (Cyclin D1). |
11; 5; 48; 20 | — |
| SECONDARY Overall Response Rate (ORR) Stratified by Protein Expression (Bcl-2) |
2; 15; 10; 62 | — |
| SECONDARY Overall Response Rate (ORR) Stratified by Protein Expression (FGFR3) |
14; 2; 64; 8 | — |
| SECONDARY Overall Survival (OS) Stratified by Protein Expression (p53). |
90.7; 92.3 | — |
| SECONDARY Overall Survival (OS) Stratified by Protein Expression (Cyclin D1) |
89.8; 95.8 | — |
| SECONDARY Overall Survival (OS) Stratified by Protein Expression (Bcl-2) |
91.7; 90.9 | — |
| SECONDARY Overall Survival (OS) Stratified by Protein Expression (FGFR3) |
92.5; 81.8 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00872521). 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.