Previously Treated Multiple Myeloma MedDRA version: 14.1 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Interventions
Product Name: Tabalumab
Product Code: LY2127399
Pharmaceutical Form: Injection
INN or Proposed INN: Tabalumab
Current Sponsor code: LY21
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
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, defined as follows (Consensus recommendations for the uniform reporting of clinical trials: report of the International MyelomaWorkshop Consensus Panel 1, Blood. 2011;117(18):4691-4695). -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
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 any of the following: •positive test results for human immunodeficiency virus (HIV) •positive test for hepatitis B • positive test results for hepatitis C virus (HCV), defined as positive for hepatitis C antibody (HepCAb) AND 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 for which the subject has not been disease-free for at least 3 years. Exceptions: patients with adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, or in situ prostate cancer are eligible regardless of the time of diagnosis/treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare progression free survival (PFS ) after treatment with tabalumab, bortezomib, and dexamethasone, to that of placebo, bortezomib, and dexamethasone in patients with relapsed/refractory Multiple Myeloma.; Secondary Objective: Secondary objectives will include comparison of treatment and placebo arms for assesment of: • Quality of response (QoR) • Best overall response (BOR) • Overall survival (OS) • Time to progression (TTP) • Time to next treatment (TNT) • Duration of response (DOR) • Time to first skeletal-related event (SRE) • The incidence of clinically significant pain response • To describe the population PK of tabalumab in patients with MM • To describe the immunogenicity of tabalumab in patients with MM Exploratory Objectives The exploratory objectives of the study are as follows: -Biomarker objectives - Health outcomes objectives ;Primary end point(s): Progression Free Survival (PFS);Timepoint(s) of evaluation of this end point: 2 cycles after the last patient is enrolled and at least 70 progression-free survival (PFS) events are observed | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PFS and Overall Survival;Timepoint(s) of evaluation of this end point: 140 PFS events | — |
Countries
Brazil, Canada, Germany, Greece, Italy, Korea, Republic of, Mexico, Netherlands, Poland, Spain, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactClinical Trial Information
Eli Lilly
Outcome results
None listed