Overview

This trial is active, not recruiting.

Condition hematologic cancer
Treatments elotuzumab (huluc63), lenalidomide, dexamethasone
Phase phase 2
Sponsor AbbVie (prior sponsor, Abbott)
Collaborator Bristol-Myers Squibb
Start date August 2008
End date May 2016
Trial size 102 participants
Trial identifier NCT00742560, 2007-006677-83, HuLuc63-1703

Summary

A Phase 1b/2, Multicenter, Open-label, Dose-escalation Study of Elotuzumab (Humanized Anti CS1 Monoclonal IgG1 Antibody) in Combination with Lenalidomide and Dexamethasone in Subjects with Relapsed Multiple Myeloma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
elotuzumab (huluc63)
Humanized Anti-CS1 Monoclonal IgG1 Antibody
lenalidomide
25 mg PO days 1 though 21 of each 28 day cycle
dexamethasone
40 mg PO days 8 and 22; 28 mg PO and 8 mg IV days 1 and 15 of each 28 day cycle.
(Experimental)
In the phase 2 portion, patients are randomized to arm 1 or arm 2.
elotuzumab (huluc63)
Humanized Anti-CS1 Monoclonal IgG1 Antibody
lenalidomide
25 mg PO days 1 though 21 of each 28 day cycle
dexamethasone
40 mg PO days 8 and 22; 28 mg PO and 8 mg IV days 1 and 15 of each 28 day cycle.
(Experimental)
In the phase 2 portion, patients are randomized to arm 1 or arm 2.
elotuzumab (huluc63)
Humanized Anti-CS1 Monoclonal IgG1 Antibody
lenalidomide
25 mg PO days 1 though 21 of each 28 day cycle
dexamethasone
40 mg PO days 8 and 22; 28 mg PO and 8 mg IV days 1 and 15 of each 28 day cycle.

Primary Outcomes

Measure
Phase 1 Portion: Maximum tolerated dose
time frame: During first 4 weeks of elotuzumab dosing
Phase 2 portion: Objective response according to the International Myeloma Working group Uniform Response Criteria
time frame: From screening through 60-day follow up period

Secondary Outcomes

Measure
Safety profile of elotuzumab
time frame: From screening through 60-day follow up period
Pharmacokinetic profile of elotuzumab
time frame: From screening through 60-day follow up period
Immunogenicity of elotuzumab
time frame: From screening through 60-day follow up period
Anti tumor activity of elotuzumab
time frame: From screening through 60-day follow up period
Phase 1 portion: Objective response according to the International Myeloma Working group Uniform Response Criteria
time frame: From screening through 60-day follow up period

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

Inclusion Criteria: 1. Age 18 years or older with a confirmed diagnosis of MM and documentation of one to three prior therapies. 2. Confirmed evidence of disease progression from immediately prior MM therapy or refractory to the immediately prior treatment. 3. Measurable disease M protein component in serum (at least 0.5 g/dL) and/or urine (if present), (>=0.2 g excreted in a 24 hour collection sample). Subjects with free light chain only disease are excluded. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2. 5. Creatinine clearance >=50 mL/min measured by Cockcroft-Gault method. 6. Hematologic parameters defined by: - Absolute neutrophil count >1000 cells/mm^3 without growth factors for 7 days. - Platelets >=75,000 cells/mm^3 (75 × 10^9/L), without platelet transfusion, within 72 hours of screening evaluation. - Hemoglobin >=8 g/dL without red blood cell transfusion within 72 hours of screening. 7. Alanine aminotransferase (ALT) AND aspartate aminotransferase (AST) <3 × upper limit of normal. 8. Total bilirubin <2 × upper limit of normal, direct bilirubin <2.0 mg/dL. 9. Negative urine pregnancy test in women of childbearing potential at screening and prior to prescribing lenalidomide. Females of childbearing potential (FCBP) must either commit to continued abstinence from heterosexual intercourse or begin acceptable methods of birth control for 28 days prior to prescribing lenalidomide. Men must agree to use a latex condom during sexual contact with FCBP even if they have had a successful vasectomy, and must agree not to donate semen during study drug therapy and for a period of time after therapy. 10. Able to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject's privacy regulations). 11. Able to take aspirin daily as prophylactic anticoagulation therapy (subjects intolerant to aspirin may use warfarin or low-molecular-weight heparin). Exclusion Criteria: 1. Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, or other cancer from which the subject has been disease-free for at least 2 years. 2. Active or prior plasma cell leukemia (defined as either 20% of peripheral WBC comprised of plasma/CD138+ cells or an absolute count of 2 x 10^9/L). 3. Uncontrolled medical problems such as diabetes mellitus, coronary artery disease, hypertension, unstable angina, arrhythmias, pulmonary disease, and symptomatic heart failure. 4. Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia. 5. Treatment with any investigational drug within 2 weeks or 3 half lives (whichever is longer) of the first dose of elotuzumab. 6. Use of corticosteroids, thalidomide, bortezomib, or cytotoxic chemotherapy within 2 weeks of the first dose of elotuzumab except for steroids with little or no systemic absorption (ie, topical or inhaled steroids). 7. Prior lenalidomide therapy. 8. Prior peripheral stem-cell transplant within 12 weeks of the first dose of elotuzumab. 9. Treatment with nitrosoureas, such as carmustine (BiCNU), nitrogen mustard agents, or melphalan, within 6 weeks of first dose of elotuzumab. 10. Neuropathy >=Grade 3 or painful neuropathy >=Grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v3.0). 11. Known active infections requiring IV antibiotic, antiviral, or antifungal therapy. 12. Hypersensitivity to recombinant proteins or excipients in elotuzumab, lenalidomide, or dexamethasone. 13. Female subjects who are pregnant or breastfeeding. 14. Subjects with serum calcium (corrected for albumin) >= 12 mg/dL.

Additional Information

Official title A Phase 1b/2, Multicenter, Open-label, Dose-escalation Study of Elotuzumab (Humanized Anti-CS1 Monoclonal IgG1 Antibody) in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed Multiple Myeloma
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by AbbVie.