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

Study Identifier:
C07-003
ClinicalTrials.gov Identifier:
NCT00648739
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Other

Study Details

Medical Condition
  • Unmapped
  • Multiple Myeloma
Study Drug
  • Drug: Samalizumab
Date
Jun 2008 - Dec 2010
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: N/A
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Relapsing or Refractory B-CLL or MM
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
  • Anticipated survival of greater than 6 months
  • Female participants of childbearing potential must agree to use 2 forms of contraception
  • Participants must have a standard indication for treatment of their malignancy
  • Is willing and able to give written informed consent prior to any procedure not considered standard of care
Exclusion Criteria
  • Absolute neutrophil count (ANC) \< 1000 x 10\^9/liter (L)
  • Platelet count \< 50,000 x 10\^9/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 mineralocorticoid potency of 10 milligrams (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 1 year of enrollment
  • Clinically significant renal, hepatic, or cardiopulmonary disease
Sex
Female & Male
Age
N/A

Study Details

Medical Condition
  • Unmapped
  • Multiple Myeloma
Study Drug
  • Drug: Samalizumab
Date
Jun 2008 - Dec 2010
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: N/A years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Relapsing or Refractory B-CLL or MM
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
  • Anticipated survival of greater than 6 months
  • Female participants of childbearing potential must agree to use 2 forms of contraception
  • Participants must have a standard indication for treatment of their malignancy
  • Is willing and able to give written informed consent prior to any procedure not considered standard of care
Exclusion Criteria
  • Absolute neutrophil count (ANC) \< 1000 x 10\^9/liter (L)
  • Platelet count \< 50,000 x 10\^9/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 mineralocorticoid potency of 10 milligrams (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 1 year of enrollment
  • Clinically significant renal, hepatic, or cardiopulmonary disease

Protocol Summary

The purpose of this study was to determine the safety and maximum tolerated dose (MTD) of ALXN6000 (samalizumab) in treating relapsing or refractory B-cell chronic lymphocytic leukemia (B-CLL) or multiple myeloma (MM) and to study how samalizumab may help the immune system fight tumors that express CD200.

Trial Locations

Location
Status
Location
Tucson, Arizona, United States, 85719
Status
N/A
Location
Atlanta, Georgia, United States, 30322
Status
N/A
Location
Morristown, New Jersey, United States, 07962
Status
N/A
Location
Durham, North Carolina, United States, 27710
Status
N/A