A Study of Tabalumab (LY2127399) in Participants With Previously Treated Multiple Myeloma (MM)
Status: | Completed |
---|---|
Conditions: | Blood Cancer, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/16/2018 |
Start Date: | July 2012 |
End Date: | July 2014 |
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Tabalumab in Combination With Bortezomib and Dexamethasone in Patients With Previously Treated Multiple Myeloma
The purpose of this study is to evaluate an investigational drug called tabalumab in
participants with Multiple Myeloma (MM) who have tried at least one other therapy in the
past. Tabalumab will be given in combination with standard doses of two other drugs that are
often used to treat MM. Study doctors will collect information about the effectiveness and
side effects of this therapy.
participants with Multiple Myeloma (MM) who have tried at least one other therapy in the
past. Tabalumab will be given in combination with standard doses of two other drugs that are
often used to treat MM. Study doctors will collect information about the effectiveness and
side effects of this therapy.
Inclusion Criteria:
- Have symptomatic and/or progressive MM that was previously treated with at least 1 and
no more than 3 prior lines of therapy
- Have measurable disease
- Have given written informed consent prior to any study-specific procedures
- Have adequate organ function
- Treatment with prior autologous transplant is permitted
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 participation in this
trial
- 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, defined as positive for hepatitis B surface
antigen (HBsAg+), OR positive for anti-hepatitis B core antibody AND positive for
hepatitis B deoxyribonucleic acid (HBV DNA), OR positive for anti-hepatitis B
surface antibody (HBsAb+) AND positive for hepatitis B deoxyribonucleic acid (HBV
DNA)
- 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 participants
- 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 B-cell activating factor (BAFF),
including LY2127399
- Have corrected QT (QTc) interval >500 millisecond (msec) on baseline 12-lead
electrocardiogram (ECG)
- Have Waldenstrom's macroglobulinemia
- History of malignancy with adequately treated basal cell or squamous cell skin cancer,
in situ cervical cancer, in situ breast cancer, in situ prostate cancer, are eligible
regardless of the time of diagnosis/treatment
We found this trial at
15
sites
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