Status:
COMPLETED
A Study of the Safety and Efficacy of CNTO 328 and Bortezomib to Bortezomib Alone in Patients With Relapsed or Refractory Multiple Myeloma
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief 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 progr...
Detailed Description
The purpose of this study is to see what effects CNTO 328 has on relapsed or refractory multiple myeloma. The study drug, CNTO 328, is a chimeric (part mouse) antibody (small protein that is important...
Eligibility Criteria
Inclusion
- 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 (\<=) 2
- Adequate bone marrow, liver, and renal function
Exclusion
- No prior treatment with bortezomib
- Not Refractory to high-dose dexamethasone
- Not \>= 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
Key Trial Info
Start Date :
November 28 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 24 2019
Estimated Enrollment :
307 Patients enrolled
Trial Details
Trial ID
NCT00401843
Start Date
November 28 2006
End Date
September 24 2019
Last Update
November 19 2019
Active Locations (80)
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1
Greenbrae, California, United States
2
Los Angeles, California, United States
3
Indianapolis, Indiana, United States
4
Albuquerque, New Mexico, United States