Safety and Dose Ranging Study of ALXN6000 to Treat Relapsing or Refractory CLL or MM

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00648739
Recruitment Status : Completed
First Posted : April 1, 2008
Last Update Posted : January 30, 2017
Information provided by (Responsible Party):
Alexion Pharmaceuticals

Brief Summary:
The purpose of this study is to determine the safety and best dose of ALXN6000 in treating relapsing or refractory B-CLL or MM and to study how ALXN6000 may help the immune system fight cancer.

Condition or disease Intervention/treatment Phase
B-cell Chronic Lymphocytic Leukemia Multiple Myeloma Drug: ALXN6000 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Open Label Study To Evaluate The Safety, Pharmacokinetics And Pharmacodynamics Of ALXN6000 In Patients With Relapsing Or Refractory B-Cell Chronic Lymphocytic Leukemia Or Multiple Myeloma
Study Start Date : June 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Arm Intervention/treatment
Experimental: 1, 2, 3, 4, 5, 6, and 7
ALXN6000 dose ranging cohorts numbered 1-7 with dosages of 50 mg/m2 to 600 mg/m2.
Drug: ALXN6000
Part A is a comparison of different dosages of ALXN6000 by cohort ranging from 50 mg/m2 up to 600 mg/m2 given as a single IV dose. Once the most appropriate dose is determined it will be given over a 28 day cycle for 4 cycles in Part B Cohort 1 = 50 mg/m2 Cohort 2 = 100 mg/m2 Cohort 3 = 200 mg/m2 Cohort 4 = 300 mg/m2 Cohort 5 = 400 mg/m2 Cohort 6 = 500 mg/m2

Primary Outcome Measures :
  1. Obtain dose, safety, PK, and PD information about ALXN6000. [ Time Frame: From first dose through 10 weeks after the last dose ]

Secondary Outcome Measures :
  1. Obtain biological information on ALXN6000 including binding to CD200 on B CLL cells; describe the effect of ALXN6000 in B-CLL patients on ORR and its components of CR, PR, nPR and SD; and in MM patients on response as defined in the protocol [ Time Frame: From first dose through 10 weeks after the last dose ]

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Relapsing or Refractory B CLL or MM
  • ECOG performance status 0-2
  • Anticipated survival of greater than 6 months.
  • Female patients of childbearing potential must agree to use two forms of contraception
  • Patients must have a standard indication for treatment of their malignancy
  • Is willing and able to give written informed consent.

Exclusion Criteria:

  • Absolute neutrophil count (ANC) < 1000 x 109/L
  • Platelet count < 50,000 x 109/L
  • Pregnant or lactating women.
  • Prior history of autoimmune hemolysis requiring therapy.
  • Prior history of immune thrombocytopenia.
  • Active autoimmune disease requiring immunosuppressive therapy.
  • Positive Coombs' Test (neither Direct or Indirect)
  • Ongoing corticosteroid treatment equivalent to the mineralocortacoid potency of 10 milligram (mg) /day of prednisone, or greater, for any condition.
  • Prior stem cell transplantation within 4 weeks prior to enrollment.
  • Prior chemotherapy for the applicable malignancy within 30 days of enrollment.
  • Neurosurgery or cranial radiation therapy within one year of enrollment.
  • Clinically significant renal, hepatic or heart disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00648739

United States, Arizona
Arizona Cancer Center at UMC North
Tucson, Arizona, United States, 85719
United States, Georgia
Emory Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, New Jersey
Hematology Oncology Assoc. of Northern NJ Carol G. Simon Cancer Center
Morristown, New Jersey, United States, 07962
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Alexion Pharmaceuticals
Principal Investigator: Leonard Heffner Emory University
Principal Investigator: Duruka Mahadevan University of Arizona College of Medicine
Principal Investigator: Charles Farber HOANNJ-Carol G. Simon Cancer Center
Principal Investigator: Moshe Talpaz University of Michigan Rogel Cancer Center
Principal Investigator: Mark Lanasa Duke University

Responsible Party: Alexion Pharmaceuticals Identifier: NCT00648739     History of Changes
Other Study ID Numbers: C07-003
First Posted: April 1, 2008    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017

Keywords provided by Alexion Pharmaceuticals:
B-cell Chronic Lymphocytic Leukemia
Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lymphatic Diseases
Leukemia, B-Cell