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

This study is currently recruiting participants.
Verified by PDL BioPharma, Inc., December 2007

Sponsored by: PDL BioPharma, Inc.
Information provided by: PDL BioPharma, Inc.
ClinicalTrials.gov Identifier: NCT00425347
  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 I

Genetics Home Reference related topics:   aceruloplasminemia    hemophilia   

MedlinePlus related topics:   Cancer    Multiple Myeloma   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study
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

Further study details as provided by PDL BioPharma, Inc.:

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

Estimated Enrollment:   50
Study Start Date:   December 2006
Estimated 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

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

Locations
United States, Arkansas
Arkansas Cancer Research Center     Recruiting
      Little Rock, Arkansas, United States, 72205
      Contact: Monica Whitwell     501-526-6990 ext 2441        
      Principal Investigator: Frits van Rhee, M.D.            
United States, California
USC/Norris Cancer Hospital     Recruiting
      Los Angeles, California, United States, 90033
      Contact: Lori Vergara     323-865-3938        
      Principal Investigator: Ann Mohrbacher, M.D.            
United States, Illinois
Northwestern University Feinberg School of Medicine     Recruiting
      Chicago, Illinois, United States, 60611
      Contact: Simbi Acharya     312-695-1383        
      Principal Investigator: Seema Singhal, M.D.            
United States, Massachusetts
University of Massachusetts Memorial Healthcare- Univ. Campus     Recruiting
      Worcester, Massachusetts, United States, 01655
      Contact: Tara Roy     508-856-1797        
      Principal Investigator: Samer Al-Homsi, M.D.            
Dana-Farber Cancer Institute     Recruiting
      Boston, Massachusetts, United States, 02115
      Contact: Deanna Tocco     617-632-3619        
      Principal Investigator: Nikhil Munshi, M.D.            
United States, Michigan
Wayne State University     Recruiting
      Detroit, Michigan, United States, 48201
      Contact: Zhiwei Sun     313-576-9453        
      Principal Investigator: Jeffrey A. Zonder, M.D.            
United States, Ohio
Cleveland Clinic     Recruiting
      Cleveland, Ohio, United States, 44195
      Contact: Becky Habecker     216-445-2612        
      Principal Investigator: Robert Dean, MD            
United States, Washington
Fred Hutchinson Cancer Research Center     Recruiting
      Seattle, Washington, United States, 98109
      Contact: Kathy Lilleby, RN     206-667-5836        
      Principal Investigator: William Bensinger, MD            

Sponsors and Collaborators
PDL BioPharma, Inc.

Investigators
Principal Investigator:     William Bensinger, MD     Fred Hutchinson Cancer Research Center    
Principal Investigator:     Robert Dean, MD     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


Related Info  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Not applicable for this trial. ( Not applicable for this trial. )
Study ID Numbers:   HuLuc63-1701
First Received:   January 18, 2007
Last Updated:   December 21, 2007
ClinicalTrials.gov Identifier:   NCT00425347
Health Authority:   United States: Food and Drug Administration

Keywords provided by PDL BioPharma, Inc.:
Multiple myeloma, MM, plasma cell myeloma, cancer  

Study placed in the following topic categories:
Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Antibodies
Hemorrhagic Disorders
Multiple myeloma
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 03, 2008




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