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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS)

Outcome Time Frame:

Baseline to Objective Disease Progression or Death From Any Cause (Approximately 28 Months)

Safety Issue:

No

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

14199

NCT ID:

NCT01602224

Start Date:

July 2012

Completion Date:

November 2014

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Denver, Colorado  
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Iowa City, Iowa  
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Phoenix, Arizona  85012
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Greenbrae, California  94904
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Athens, Georgia  30607
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Indianapolis, Indiana  46227
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Overland Park, Kansas  66210
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Las Vegas, Nevada  89169
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Salt Lake City, Utah  84106
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Springfield, Massachusetts  
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Omaha, Nebraska  68114
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Albuquerque, New Mexico  87106
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Lexington, Kentucky  40536