A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study of LY2127399 in Combination with Bortezomib and Dexamethasone in Patients with Previously Treated Multiple Myeloma

• Conditions: Previously Treated Multiple Myeloma; MedDRA version: 15.0Level: PTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-005103-32-IT
• Lead Sponsor: ELI LILLY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-03
• Last Update Posted: 14 September 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 771

Inclusion Criteria

- Have symptomatic and/or progressive multiple myeloma that was previously treated with at least 1 and no more than 3 prior lines of therapy -Have measurable disease -Are =18 years of age -Have given written informed consent prior to any study-specific procedures -Have adequate organ function -Treatment with prior autologous transplant is permitted
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

Have had less than a minimal response or have had progressive disease within 60 days of most recent therapy with a proteasome inhibitor • -Plan to proceed to autologous transplant for consolidation after treatment on Study JDCG • -Have an active infection or ongoing treatment for systemic infection (''ongoing treatment'' does not include prophylactic anti-infectives), chest x-ray suggestive of tuberculosis, or history/risk of chronic/latent infection that may reactivate in the presence of study therapy • -Have positive test results for human immunodeficiency virus (HIV), evidence of hepatitis B (positive for hepatitis B surface antigen, or positive for hepatitis B core antibody and negative for hepatitis B surface antibody) or positive test results of hepatits C virus (HCV; positive for anti-hepatitis C antibody). A positive test for HCV is defined as a) positive for hepatitis C antibody (HepCAb), and b) confirmed positive via the hepatitis C recombinant immunoblot assay.-Prior allogeneic hematopoietic stem cell transplant

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified