A Study of the Safety and Efficacy of CNTO 328 and Bortezomib to Bortezomib Alone in Patients With Relapsed or Refractory Multiple Myeloma

• Status: Completed
• Trial end date: 2019-09-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Antibodies, Monoclonal; BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Siltuximab

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 (<=) 2

• Adequate bone marrow, liver, and renal function

Exclusion Criteria:

• 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