A Study of Tabalumab in Participants With Previously Treated Multiple Myeloma (MM) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Multiple Myeloma	Drug: Placebo Drug: Dexamethasone Drug: Bortezomib Biological: Tabalumab	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone sodium phosphate Bortezomib

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Progression Free Survival (PFS) [ Time Frame: Baseline to Objective Disease Progression or Death From Any Cause (Approximately 28 Months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall Survival [ Time Frame: Baseline to Death From Any Cause (Approximately 28 Months ) ] [ Designated as safety issue: No ]
Time to First Skeletal-Related Event (SRE) [ Time Frame: Baseline to Date of First Skeletal Related Event (Approximately 28 Months) ] [ Designated as safety issue: No ]
Number of Participants with >30% Reduction in Brief Pain Inventory (BPI) - Worst Pain Score [ Time Frame: Baseline through End of Treatment (Approximately 28 Months) ] [ Designated as safety issue: No ]
Time to Progression (TTP) [ Time Frame: Baseline to Objective Disease Progression or Death from MM (Approximately 28 Months) ] [ Designated as safety issue: No ]
Duration of Response [ Time Frame: Time from Response to Objective Disease Progression (Approximately 28 Months) ] [ Designated as safety issue: No ]
Time to Next Treatment (TNT) [ Time Frame: Baseline to Initiation of New Cancer Treatment or Death From Any Cause (Approximately 28 Months) ] [ Designated as safety issue: No ]
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tabalumab [ Time Frame: Predose through Study Follow-Up (Approximately 28 Months) ] [ Designated as safety issue: No ]
PK: Time to Maximum Plasma Concentration (Tmax) of Tabalumab [ Time Frame: Predose through Study Follow-Up (Approximately 28 Months) ] [ Designated as safety issue: No ]
PK: Partial Area Under the Curve (pAUC) for Tabalumab [ Time Frame: Predose through Study Follow-Up (Approximately 28 Months) ] [ Designated as safety issue: No ]
Number of Participants Developing Anti-tabalumab Antibodies [ Time Frame: Baseline through Study Follow-Up (Approximately 28 Months) ] [ Designated as safety issue: Yes ]
Proportion of Participants with Best Overall Response (BOR)in Each Category [ Time Frame: Baseline to Objective Disease Progression or Initiation of New Cancer Treatment (Approximately 28 Months) ] [ Designated as safety issue: No ]
Number of Participants with a Given Best Objective Myeloma Response (Quality of Response [QoR]) [ Time Frame: Baseline to Objective Disease Progression or Initiation of New Cancer Treatment (Approximately 28 Months) ] [ Designated as safety issue: No ]

Estimated Enrollment:	213
Study Start Date:	July 2012
Estimated Study Completion Date:	November 2014
Estimated Primary Completion Date:	November 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 100 mg Tabalumab+Dexamethasone+Bortezomib 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 8 cycles.	Drug: Dexamethasone Administered orally Drug: Bortezomib Administered SQ Biological: Tabalumab Administered IV Other Name: LY2127399
Experimental: 300 mg Tabalumab+Dexamethasone+Bortezomib 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 8 cycles. Bortezomib 1.3 mg/m^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles.	Drug: Dexamethasone Administered orally Drug: Bortezomib Administered SQ Biological: Tabalumab Administered IV Other Name: LY2127399
Placebo Comparator: Placebo Comparator: Placebo + Dexamethasone + Bortezomib 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 8 cycles. Bortezomib 1.3 mg/m^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles.	Drug: Placebo Administered IV Drug: Dexamethasone Administered orally Drug: Bortezomib Administered SQ

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01602224

Contacts

Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559)

1-317-615-4559

Show 69 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

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)

Eli Lilly and Company

More Information

No publications provided

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01602224 History of Changes
Other Study ID Numbers:	14199, H9S-MC-JDCG
Study First Received:	May 16, 2012
Last Updated:	June 14, 2013
Health Authority:	United States: Food and Drug Administration Brazil: Ministry of Health Canada: Public Health Agency of Canada France: Ministry of Health Germany: Ministry of Health Greece: Ministry of Health and Welfare Italy: Ministry of Health Korea: Food and Drug Administration Mexico: Ministry of Health Netherlands: Ministry of Health, Welfare and Sport Poland: Ministry of Health Spain: Ministry of Health Taiwan : Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency Turkey: Ministry of Health

Additional relevant MeSH terms:

Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate

Dexamethasone
Dexamethasone 21-phosphate
Bortezomib
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on June 18, 2013