Phase 3
Completed N=93
Study of Bortezomib and Dexamethasone With or Without Cyclophosphamide in Patients With Relapsed or Not Controllable Multiple Myeloma
Source: ClinicalTrials.gov NCT00813150 ↗Enrolled (actual)
93
Serious AEs
31.2%
Results posted
Aug 2014
Primary outcomePrimary: Time to Progression of Disease — 12.6; 9.9 Months — p=0.196
Summary
The purpose of this study is to compare bortezomib, dexamethasone and cyclophosphamide to bortezomib and dexamethasone alone for primary refractory or relapsed multiple myeloma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Progression of Disease |
12.6; 9.9 | 0.196 |
| SECONDARY Progression-Free Survival (PFS) |
12.6; 9.9 | 0.196 |
| SECONDARY Overall Survival (OS) |
NA; 41.50 | 0.645 |
| SECONDARY Overall Response Rate (ORR) - International Myeloma Working Group (IMWG) Response Criteria |
74.4; 70.2 | 0.814 |
Eligibility Criteria
Inclusion Criteria
- Previously diagnosed with multiple myeloma
- Primary refractory multiple myeloma or relapsed following 1 to 3 previous lines of therapy
- Karnofsky performance status must be equal to 60 percentage (ie, better or equal performance than requiring some help and taking care of most personal requirements)
- Has life expectancy estimated at screening must be of at least 6 months
- Agrees to protocol-defined use of effective contraception
Exclusion Criteria
- Not received more than three previous lines of therapy for multiple myeloma
- Not received nitrosoureas or any other chemotherapy or immunotherapy or antibody therapy for multiple myeloma within 6 to 8 weeks before enrolment. Plasmapheresis must not be applied within 2 weeks before enrolment
- Patients with peripheral neuropathy or neuropathic pain of Grade 2 or greater intensity
- Patients with poorly controlled cardio vascular, vascular, pulmonary, gastro-intestinal, endocrine, neurological, psychiatric, hepatic, renal or metabolic diseases or hematological disorders
- Not have oligosecretory or non-secretory multiple myeloma
Data sourced from ClinicalTrials.gov (NCT00813150). 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.