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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

Phase 1/Phase 2
18 Years
Open (Enrolling)
Hematologic Cancer

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Trial Information

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

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

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

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase 1 Portion: Maximum tolerated dose

Outcome Time Frame:

During first 4 weeks of elotuzumab dosing

Safety Issue:


Principal Investigator

Anil Singhal, PhD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

August 2008

Completion Date:

December 2014

Related Keywords:

  • Hematologic Cancer
  • multiple myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Hematologic Neoplasms



Site Reference ID/Investigator# 63587 Atlanta, Georgia  30322
Site Reference ID/Investigator# 63588 Boston, Massachusetts  02115
Site Reference ID/Investigator# 63591 Boston, Massachusetts  02114
Site Reference ID/Investigator# 63586 Ann Arbor, Michigan  48109
Site Reference ID/Investigator# 63592 Detroit, Michigan  48201
Site Reference ID/Investigator# 63589 St. Louis, Missouri  63110
Site Reference ID/Investigator# 63585 New York, New York  10029