Phase 2
Completed N=395
A Study of Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Untreated Multiple Myeloma and Planned for a High Dose Chemotherapy
Source: ClinicalTrials.gov NCT00833560 ↗Enrolled (actual)
395
Serious AEs
26.1%
Results posted
Mar 2014
Primary outcomePrimary: Participants With Complete Response (CR) + Partial Response (PR) (Efficacy Set) — 334 Participants — p=<0.0001
Summary
The purpose of this study is to evaluate the safety and effectiveness of bortezomib in combination with a standard regimen of cyclophosphamide and dexamethasone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Complete Response (CR) + Partial Response (PR) (Efficacy Set) |
334 | <0.0001 sig |
| SECONDARY Participants With Complete Response (CR) + Partial Response (PR) (Per-protocol Analysis Set) |
284 | <0.0001 sig |
| SECONDARY Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Efficacy Set) |
90.2; 89.5; 74.2; 87.5; 84.3 | — |
| SECONDARY Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Per-protocol Set) |
92.4; 91.2; 87.5; 88.5; 85.1 | — |
Eligibility Criteria
Inclusion Criteria
- Cytologically or histologically diagnosed with multiple myeloma stage II/III
- Participants without preceding cytostatic (tending to retard cellular activity and multiplication) treatment (pretreatment with radiation or dexamethasone is allowed)
- Agree to use one of the contraception methods as defined in the protocol
- Karnofsky performance status 60 percent or more
- Adequate laboratory test values
Exclusion Criteria
- Non-secretory multiple myeloma
- Estimated life expectancy less than 3 months
- History of cancer (except basal cell carcinoma) in the last 5 years
- Peripheral neuropathy (disorder of the peripheral nerves) grade 2 or more
- Positive human immunodeficiency virus test and active hepatitis B and/or hepatitis C
- Pregnant or breast-feeding female participants
Data sourced from ClinicalTrials.gov (NCT00833560). 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.