A Phase I/II Dose Escalation Study Assessing the Toxicity and Efficacy of 153-Samarium-EDTMP in Place of TBI in the Conditioning Regimen for PBSCT for Patients With Multiple Myeloma
18 Years
N/A
Both
Multiple Myeloma and Plasma Cell Neoplasm
Trial Information
A Phase I/II Dose Escalation Study Assessing the Toxicity and Efficacy of 153-Samarium-EDTMP in Place of TBI in the Conditioning Regimen for PBSCT for Patients With Multiple Myeloma
OBJECTIVES:
- To find the maximum tolerated dose of samarium Sm 153 lexidronam pentasodium when given
with fixed high-dose melphalan as a conditioning regimen for autologous peripheral
blood stem cell transplantation in patients with multiple myeloma. (Phase I)
- To assess the response rates of this regimen in these patients. (Phase II)
OUTLINE: This is a phase I, dose-escalation study of samarium Sm 153 lexidronam pentasodium
followed by a phase II study.
- Phase I: Patients receive samarium Sm 153 lexidronam pentasodium IV once between days
-14 and -10. Patients also receive melphalan IV on day -1. Patients undergo peripheral
blood stem cell transplantation on day 0. Patients receive sargramostim (GM-CSF)
subcutaneously once daily beginning on day 6 and continuing until blood counts recover.
- Phase II: Patients receive samarium Sm 153 lexidronam pentasodium at the MTD determined
in phase I .
Blood samples are collected periodically to determine clearance of samarium Sm 153
lexidronam pentasodium and bone marrow dosimetry.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of multiple myeloma requiring treatment
- Must have at least 2 x 10^6 CD34+ cells collected for peripheral blood stem cell
transplantation
PATIENT CHARACTERISTICS:
Inclusion criteria:
- ECOG performance status (PS) 0-2 (ECOG PS > 2 allowed if secondary to neuropathy or
acute bone event)
- Direct bilirubin ≤ 2.0 mg/dL
- Alkaline phosphatase ≤ 750 μ/L
- Creatinine ≤ 3.0 mg/dL
- Ejection fraction ≥ 45%
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception for 6 months after the completion
of study therapy
Exclusion criteria:
- DLCO < 50%
- FVC < 50%
- FEV_1 < 50%
- Active malignancy with the exception of nonmelanoma skin cancer
- Uncontrolled infection
- NYHA class III-IV cardiac disease
PRIOR CONCURRENT THERAPY:
- May or may not have received prior chemotherapy
- At least 3 weeks since prior chemotherapy
- Cyclophosphamide pulsing for stem cell collection allowed
- At least 4 weeks since prior biologic therapy
- At least 2 weeks since prior bisphosphonates and bisphosphonates maybe resumed 1
month post-study treatment
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Number of toxicity incidents (Phase I)
Safety Issue:
Yes
Principal Investigator
Angela Dispenzieri, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000582552
NCT ID:
NCT00602706
Start Date:
January 2000
Completion Date:
July 2010
Related Keywords:
- Multiple Myeloma and Plasma Cell Neoplasm
- refractory multiple myeloma
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
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