Phase 2
N=220
A Study of Tabalumab (LY2127399) in Participants With Previously Treated Multiple Myeloma (MM)
Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT01602224 ↗Enrolled (actual)
220
Serious AEs
42.9%
Results posted
Aug 2018
Primary outcome: Primary: Progression Free Survival (PFS) — 6.6; 7.5; 7.6 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); Dexamethasone (Drug); Bortezomib (Drug); Tabalumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
6.6; 7.5; 7.6 | — |
| SECONDARY Overall Survival |
NA; NA; NA | — |
| SECONDARY Time to First Skeletal-Related Event (SRE) |
NA; NA; NA | — |
| SECONDARY Number of Participants With >30% Reduction in Brief Pain Inventory (BPI) - Worst Pain Score |
37; 30; 30 | — |
| SECONDARY Time to Progression (TTP) |
6.6; 8.2; 8.1 | — |
| SECONDARY Duration of Response (DoR) |
7.9; 8.6; 7.7 | — |
| SECONDARY Time to Next Treatment (TNT) |
10.1; 9.9; 11.7 | — |
| SECONDARY Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tabalumab |
38.0; 103; 47.9; 131; 69.0; 189 | — |
| SECONDARY PK: Time to Maximum Plasma Concentration (Tmax) of Tabalumab |
1.5; 1.58; 0.92; 0.76; 0.75; 0.73 | — |
| SECONDARY PK: Area Under the Curve Over the Dosing Interval (AUC-T) for Tabalumab |
7790; 2220; 11600; 35400; 25300; 70100 | — |
| SECONDARY Number of Participants Developing Anti-tabalumab Antibodies |
— | — |
| SECONDARY Participants With Best Overall Response (BOR) in Each Category |
1; 0; 2; 10; 4; 4 | — |
| SECONDARY Number of Participants With a Given Best Objective Myeloma Response (Quality of Response [QoR]) |
1; 0; 2; 10; 4; 4 | 0.401 |
| SECONDARY Overall Response Rate (ORR) |
58.1; 59.5; 61.1 | — |
Summary
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.
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 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
Data sourced from ClinicalTrials.gov (NCT01602224). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.