Phase I, Multi-Center, Open-Label, Dose Escalation Study of HuLuc63 in Subjects With Advanced Multiple Myeloma

NCT00425347 | Completed Phase 1 DMC

• 1 other identifier: HuLuc63-1701
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 8

Brief Summary

To identify the MTD of HuLuc63 administered intravenously (IV) for 4 doses.2. To evaluate the safety of HuLuc63 IV given every other week for 4 doses.

Conditions

Multiple Myeloma

Keywords

Multiple myeloma, MM, plasma cell myeloma, cancer

Outcome Measures

Primary Outcomes (1)

• Not applicable for this trial.

  Not applicable for this trial.

Interventions

HuLuc63 DRUG

Not applicable for HuLuc63.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females, age 18 years or older.
• Diagnosis of advanced multiple myeloma, after at least 2 prior therapies for MM.
• Measurable disease M component in serum (at least 0.5 G/dL) and/or urine (≥0.2 g excreted in a 24-hour collection sample).
• Not eligible for stem cell or bone marrow transplant or have refused stem cell or bone marrow transplant or have relapsed after autologous or allogeneic stem cell or bone marrow transplant.
• ECOG performance status 0-2 (Appendix E).
• ALT or AST ≤3 x ULN.
• Total bilirubin ≤2 x ULN (unless related to MM).
• Serum creatinine ≤2.0 mg/dL (unless related to MM, then ≤ 3.0 mg/dL).
• Must have adequate bone marrow function defined as: Absolute neutrophil count \>1,000 cells/mm3; platelets ≥75,000 cells/mm3; and hemoglobin ≥8 g/dL. No platelet transfusion within 72 hours of obtaining screening platelet count.
• Serum calcium (corrected for albumin) level within normal range (treatment of hypercalcemia is allowed and subject may enroll if hypercalcemia returns to normal with treatment).
• Signed and dated informed consent.
• Use of appropriate contraception where applicable.
• Negative pregnancy test within 48 hours prior to first dose in women of childbearing potential.
• Must have 2-dimensional echocardiogram or MUGA indicating LVEF ≥ 45% within 30 days prior to first dose of study drug.
• 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).

You may not qualify if:

• Subjects will be ineligible for this study if they meet any one of the following criteria:
• Life expectancy of less than 3 months.
• 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 5 years.
• Plasma cell leukemia (active or prior).
• Uncontrolled medical problems such as diabetes mellitus, coronary artery disease, hypertension, unstable angina, arrhythmias, pulmonary, hepatic, and renal diseases unless renal insufficiency is felt to be secondary to multiple myeloma (serum creatinine \> 2.0 mg/dL).
• Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia.
• Corticosteroid, Velcade® or other proteosome inhibitor, thalidomide, lenalidomide (Revlimid®), or melphalan within 2 weeks of the first dose of HuLuc63; nitrogen mustard agents within 6 weeks of the first dose of HuLuc63.
• Investigational drug within 4 weeks or 5 half-lives (whichever is greater) of the first dose of HuLuc63.
• Stem cell or bone marrow transplant within 12 weeks prior to the first dose of HuLuc63.
• Biological agents including intravenous immune globulin (IVIG) and monoclonal antibodies within 4 weeks of the first dose of HuLuc63.
• Neuropathy \>Grade 2 (according to the NCI CTCAE v3.0 criteria scale).
• Symptomatic orthostatic hypotension.
• Evidence of amyloidosis.
• Known active infections requiring antibiotics, antivirals, or antifungals.
• Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse follow-up evaluation.

Sponsors & Collaborators

• Facet Biotech: lead

Study Sites (8)

Arkansas Cancer Research Center

Little Rock, Arkansas, 72205, United States

Location

USC/Norris Cancer Hospital

Los Angeles, California, 90033, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Massachusetts Memorial Healthcare- Univ. Campus

Worcester, Massachusetts, 01655, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms

Interventions

elotuzumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• William Bensinger, MD

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

• Robert Dean, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Frits van Rhee, M.D.

  Arkansas Cancer Research Center

  PRINCIPAL INVESTIGATOR

• Seema Singhal, M.D.

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

• Jeffrey A. Zonder, M.D.

  Wayne State University

  PRINCIPAL INVESTIGATOR

• Samer Al-Homsi, M.D.

  University of Massachusetts Memorial Healthcare

  PRINCIPAL INVESTIGATOR

• Nikhil Munshi, M.D.

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

• Ann Mohrbacher, M.D.

  USC/Norris Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 18, 2007
• First Posted: January 22, 2007
• Study Start: December 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: July 1, 2009
• Last Updated: September 23, 2009

Record last verified: 2009-09

Locations

US (8)