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Phase I Study of Parathyroid Hormone in Combination With G-CSF in Patients Requiring Additional Stem Cell Mobilization

Phase 1
18 Years
75 Years
Not Enrolling
Lymphoma, Multiple Myeloma, Acute Myelogenous Leukemia

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Trial Information

Phase I Study of Parathyroid Hormone in Combination With G-CSF in Patients Requiring Additional Stem Cell Mobilization

Patients will start treatment within 21 days of the determination of inadequate
mobilization. PTH treatment will be given in 4 cohorts: 40 mcg, 60 mcg, 80 mcg, and 10 mcg.
PTH will be given on day 1 and continue until stem cell collections are complete or a
maximum of 20 days. G-CSF 10 mcg/kg will be given on days 10-14 and continue until stem
cell collections are complete. Patients with inadequate CD34+ cells on Day 14 will meet off
study criteria and not continue with PTH/G-CSF.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess safety of parathyroid hormone in combination with G-CSF when used as a mobilization agent at four different dosing levels.

Principal Investigator

Karen Ballen, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital, Harvard University


United States: Institutional Review Board

Study ID:




Start Date:

July 2004

Completion Date:

April 2007

Related Keywords:

  • Lymphoma
  • Multiple Myeloma
  • Acute Myelogenous Leukemia
  • Mobilization
  • Stem Cell
  • Parathyroid Hormone
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



MD Anderson Cancer CenterHouston, Texas  77030-4096
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Dana Farber Cancer InstituteBoston, Massachusetts  02115