A Study of Tabalumab (LY2127399) in Participants With Previously Treated Multiple Myeloma (MM)

Lilly

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma

Treatments: Biological: Tabalumab; Drug: Dexamethasone; Drug: Placebo; Drug: Bortezomib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01602224

14199

H9S-MC-JDCG (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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220 participants in 3 patient groups, including a placebo group

100 mg Tabalumab+Dexamethasone (Dex)+Bortezomib (BTZ)

Experimental group

Description:

Tabalumab 100 milligram (mg) administered once intravenously (IV) over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 milligram per square meter (mg/m\^2) administered once subcutaneously (SQ) on Days 1, 4, 8 and 11 every 21 days for a minimum 8 cycles. All treatment may continue past 8 cycles.

Treatment:

Drug: Bortezomib

Drug: Dexamethasone

Biological: Tabalumab

300 mg Tabalumab+Dexamethasone+Bortezomib

Experimental group

Description:

Tabalumab 300 mg administered once IV over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for a minimum 8 cycles. Bortezomib 1.3 mg/m\^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles. All treatment may continue past 8 cycles.

Treatment:

Drug: Bortezomib

Drug: Dexamethasone

Biological: Tabalumab

Placebo Comparator: Placebo + Dexamethasone + Bortezomib

Placebo Comparator group

Description:

Placebo administered once IV on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for a minimum 8 cycles. Bortezomib 1.3 mg/m\^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles. All treatment may continue past 8 cycles.

Treatment:

Drug: Bortezomib

Drug: Dexamethasone

Drug: Placebo