A Study of Tabalumab in Participants With Previously Treated Multiple Myeloma (MM)
Status: Recruiting
Phase:
Diagnosis: Multiple Myeloma
NCT ID: NCT01602224
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-325
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.
Conducting Institutions:
Massachusetts General Hospital, Brigham and Women's Hospital, Dana-Farber Cancer Institute
Overall PI:
Noopur Raje, MD,
Massachusetts General Hospital
Site-responsible Investigators:
Paul Richardson, MD,
Dana-Farber Cancer Institute
Contacts:
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute:
Deborah Doss, 617-632-5672,
ddoss@partners.org
Eligibility Criteria
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 results for hepatitis B, defined as positive for hepatitis B
surface antigen (HBsAg+) OR 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 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 participant has been disease-free for at least 3 years