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

This study has been completed.
Sponsor:
Information provided by:
Facet Biotech
ClinicalTrials.gov Identifier:
NCT00425347
First received: January 18, 2007
Last updated: September 21, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: HuLuc63
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I, Multi-Center, Open-Label, Dose Escalation Study of HuLuc63 (Humanized Anti-CS1 Monoclonal IgG1 Antibody) in Subjects With Advanced Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Facet Biotech:

Primary Outcome Measures:
  • Not applicable for this trial. [ Time Frame: Not applicable for this trial. ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: December 2006
Study Completion Date: July 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: HuLuc63
    Not applicable for HuLuc63.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Eligible subjects will be considered for inclusion in this study if they meet all of the following criteria:

  • 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).

Exclusion Criteria:

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.
  • Hypersensitivity to recombinant proteins or excipients in the investigational agent.
  • Any condition that in the investigator's opinion makes the subject unsuitable for study participation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425347

Locations
United States, Arkansas
Arkansas Cancer Research Center
Little Rock, Arkansas, United States, 72205
United States, California
USC/Norris Cancer Hospital
Los Angeles, California, United States, 90033
United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
University of Massachusetts Memorial Healthcare- Univ. Campus
Worcester, Massachusetts, United States, 01655
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Facet Biotech
Investigators
Principal Investigator: William Bensinger, MD Fred Hutchinson Cancer Research 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
  More Information

Additional Information:
No publications provided

Responsible Party: Lisa Bell, Senior Director, Facet Biotech
ClinicalTrials.gov Identifier: NCT00425347     History of Changes
Obsolete Identifiers: NCT00429741
Other Study ID Numbers: HuLuc63-1701
Study First Received: January 18, 2007
Last Updated: September 21, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Facet Biotech:
Multiple myeloma, MM, plasma cell myeloma, cancer

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014