Phase 3
N=93
Study of Bortezomib and Dexamethasone With or Without Cyclophosphamide in Patients With Relapsed or Not Controllable Multiple Myeloma
Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT00813150 ↗Enrolled (actual)
93
Serious AEs
31.2%
Results posted
Aug 2014
Primary outcome: Primary: Time to Progression of Disease — 12.6; 9.9 Months — p=0.196
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dexamethasone (Drug); Bortezomib (Drug); Cyclophosphamide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen-Cilag G.m.b.H
- Primary completion
- Jan 2013
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 |
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.
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.