Phase 2
Completed N=307
A Study of the Safety and Efficacy of CNTO 328 and Bortezomib to Bortezomib Alone in Patients With Relapsed or Refractory Multiple Myeloma
Source: ClinicalTrials.gov NCT00401843 ↗Enrolled (actual)
307
Serious AEs
33.4%
Results posted
Aug 2015
Primary outcomePrimary: Progression-free Survival — 232; 245 days
Summary
The purpose of Part 1 of the study is to determine the safety of the combination of Siltuximab (CNTO 328) and bortezomib (Velcade). The purpose of Part 2 of the study is to compare the length of progression free survival for those patients given CNTO 328 and bortezomib to those patients given bortezomib alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
232; 245 | — |
| PRIMARY Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) |
21; 138; 140; 10; 44; 47 | — |
| SECONDARY Percentage of Participants With Best Confirmed Response of Complete Response (CR) or Partial Response (PR) (Overall Response Rate) |
46.7; 55.0 | — |
| SECONDARY Percentage of Participants With Confirmed Complete Response (CR Rate) |
7.3; 10.7 | — |
| SECONDARY Overall Survival |
1121; 937 | — |
Eligibility Criteria
Inclusion Criteria
- Measurable secretory disease defined as either serum monoclonal paraprotein, (M-protein) greater than or equal to (>=)1 gram per deciliter (g/dL) or urine monoclonal (light chain) protein (> 200 mg/24 hours)
- Documented disease progression after at least 1 prior line of therapy but no more than 3 or have had no response to previous treatment (primary refractory disease)
- ECOG performance status score of less than or equal to ( = Grade 2 peripheral neuropathy
- Have not received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant
- No prior or concomitant malignancy (other than multiple myeloma) except adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or other cancer for which the patient has been disease-free for <= 3 years
Data sourced from ClinicalTrials.gov (NCT00401843). 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.