Multiple Myeloma Clinical Trial
Official title:
Phase I Study of Parathyroid Hormone in Combination With G-CSF in Patients Requiring Additional Stem Cell Mobilization
Verified date | April 2007 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this study is to determine the safety of parathyroid hormone in combination with G-CSF when used as a stem cell mobilization regimen for patients who fail to mobilize sufficient progenitor stem cells after one or two attempts.
Status | Completed |
Enrollment | 12 |
Est. completion date | April 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Disease status: NHL or HD refractory to chemotherapy, relapsed, o high risk first remission; multiple myeloma; AML in second or subsequent remission or in first remission with adverse cytogenetics or antecedent hematologic disorder. - Failed one or two mobilization attempts. - ECOG performance status of 0, 1, or 2. Exclusion Criteria: - Cardiac disease: symptomatic congestive heart failure, angina pectoris or uncontrolled hypertension - Pulmonary disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease. - Renal disease: serum creatinine > 2 mg/dl - Hepatic disease: SGOT or SGPT > 3x normal; serum bilirubin > 2.0 mg/dl that is not due to Gilbert's syndrome or hemolysis - Calcium > 10.5 - Phosphate < 1.6 - Uncontrolled infection - Pregnancy or breast feeding mother |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | Beth Israel Deaconess Medical Center, Dana-Farber Cancer Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess safety of parathyroid hormone in combination with G-CSF when used as a mobilization agent at four different dosing levels. | |||
Secondary | To evaluate the peripheral blood CD34+ count after second mobilization. | |||
Secondary | To evaluate CD34+ cells/kg from apheresis after second mobilization. | |||
Secondary | To evaluate the percent of patients for whom adequate numbers of CD34+ cells are obtained. | |||
Secondary | To evaluate transfusion support. | |||
Secondary | To evaluate the days to neutrophil engraftment (ANC >500) post autologous transplant. | |||
Secondary | To evaluate the days to platelet engraftment (platelet count > 20,000 unsupported). |
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