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A Phase 1/2, Multi-center, Open-label, Dose-escalation Study of Elotuzumab(Humanized Anti-CS1 Monoclonal IgG1 Antibody) and Bortezomib in Subjects With Multiple Myeloma Following One to Three Prior Therapies.

Phase 1
18 Years
Not Enrolling
Multiple Myeloma

Thank you

Trial Information

A Phase 1/2, Multi-center, Open-label, Dose-escalation Study of Elotuzumab(Humanized Anti-CS1 Monoclonal IgG1 Antibody) and Bortezomib in Subjects With Multiple Myeloma Following One to Three Prior Therapies.

The phase 2 portion of this study was not initiated because a decision was made to conduct a
phase 2 randomized clinical trial.

Inclusion Criteria

Inclusion Criteria

1. Males or females, age 18 years or older.

2. Diagnosis of MM and documentation of 1 to 3 prior therapies.

3. M-protein spike (complete immunoglobulin molecule) of >= 1g/dL in serum and/or >= 0.5
g excreted in a 24-hour urine collection sample. Light chain only disease is not an
inclusion criteria.

4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

5. No prior bortezomib treatment OR responsive (PR or better) to prior bortezomib
treatment for a minimum of 3 months OR responsive to prior bortezomib treatment at
the time of going to another treatment or ceasing treatment.

6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) <=3 x upper limit
of normal (ULN).

7. Total bilirubin <=2 x ULN.

8. Serum creatinine <=2.0 mg/dL (unless related to MM, then <=3.0 mg/dL).

9. Must have adequate bone marrow function defined as:

- Absolute neutrophil count >1,000 cells/mm3 (1.0 x 10^9 cells/L) without growth
factor support for 7 days;

- Platelets >=75,000 cells/mm3 (75 x 10^9 cells/L) without transfusion within 72
hours of screening;

- Hemoglobin >=8 g/dL without red blood cell transfusion within 2 weeks of

10. Serum calcium (corrected for albumin) level at or below ULN range (treatment of
hypercalcemia is allowed and subject may enroll if hypercalcemia returns to normal
with standard treatment); additional screening time may be allowed for confirmation -
consult with sponsor's medical monitor.

11. Use of appropriate contraception where applicable.

12. Negative urine pregnancy test where applicable.

13. Must have 2-dimensional echocardiogram indicating left ventricular ejection fraction
(LVEF) >=45% within 30 days prior to the first dose of elotuzumab.

14. Ability 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 privacy regulations).

Exclusion Criteria

1. Life expectancy of less than 3 months.

2. 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.

3. Uncontrolled medical problems such as diabetes mellitus, coronary artery disease,
hypertension, unstable angina, arrhythmias, pulmonary,(including acute diffuse
infiltrative pulmonary and pericardial disease), hepatic, and renal diseases unless
renal insufficiency is felt to be secondary to MM.

4. Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma
cell dyscrasia.

5. Prior treatment with bortezomib in 3 months prior to the first dose.

6. Thalidomide, lenalidomide cytotoxic chemotherapy, or corticosteroids (except prior to
infusion of first dose of study drug as prophylaxis for infusion reactions) within 2
weeks of the first dose of elotuzumab.

7. Prior therapy with anti-CD56+ therapeutics.

8. Radiotherapy within 2 weeks prior to the first dose of elotuzumab.

9. Investigational drug within 3 weeks or 3x the half-life of the investigational drug
(whichever is longer ) of the first dose of elotuzumab.

10. Prior peripheral stem cell transplant within 12 weeks of the first dose of

11. Nitrogen mustard agents, melphalan, or monoclonal antibodies within 6 weeks of the
first dose of elotuzumab.

12. Neuropathy >=Grade 2 (NCI CTCAE v3.0).

13. Current orthostatic hypotension.

14. Known active infections requiring antibiotic, antiviral, or antifungal therapy.

15. Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or
confuse follow-up evaluation.

16. Any condition that in the investigator's opinion makes the subject unsuitable for
study participation.

17. Hypersensitivity to recombinant proteins or excipients in elotuzumab or bortezomib.

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:

Identify the maximum tolerated dose of elotuzumab in combination with bortezomib (phase 1).

Outcome Description:

The highest dose level of elotuzumab at which <= 1 dose-limiting toxicity occurs in 6 subjects

Outcome Time Frame:

First cycle of treatment.

Safety Issue:


Principal Investigator

Anil Singhal, PhD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2008

Completion Date:

March 2012

Related Keywords:

  • Multiple Myeloma
  • Patients After One to three Prior Therapies
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Site Reference ID/Investigator# 63853Los Angeles, California  90033
Site Reference ID/Investigator# 63855Chicago, Illinois  60637
Site Reference ID/Investigator# 63847Boston, Massachusetts  02115
Site Reference ID/Investigator# 63852Ann Arbor, Michigan  48109-5936
Site Reference ID/Investigator# 63854Hackensack, New Jersey  07601
Site Reference ID/Investigator# 63850Buffalo, New York  14263
Site Reference ID/Investigator# 63849Columbus, Ohio  43210
Site Reference ID/Investigator# 63848Seattle, Washington  98109