A study in in Patients with Previously Treated Multiple Myeloma

• Conditions: Previously Treated Multiple Myeloma; MedDRA version: 14.1Level: 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-GR
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-18
• Last Update Posted: 10 November 2014

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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Are enrolled in or discontinued from a clinical trial of any drug or device within 21 days prior to the first dose of assigned study treatment

• 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.
• Have had significant allergy to human/humanized monoclonal antibodies that, in the opinion of the investigator, poses an unacceptable risk to the patient.
• Have known hypersensitivity or contraindication to any of the study therapies or excipients.
• Prior allogeneic hematopoietic stem cell transplant.
• Prior therapy with experimental agents targeting BAFF, including LY2127399.
• Have corrected QT (QTc) interval >500 msec on baseline 12-lead electrocardiogram (ECG).
• Have Waldenstrom’s macroglobulinemia.
• History of malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer, or other cancer for which the subject has been disease-free for at least 3 years.

Study & Design

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