Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial
Official title:
A Phase I Study of Samarium Sm-153 Lexidronam Combined With Bortezomib for Patients With Relapsed or Refractory Multiple Myeloma
RATIONALE: Radioactive substances, such as samarium 153, may release radiation as it breaks
down and kill cancer cells. Bortezomib may stop the growth of cancer cells by blocking some
of the enzymes needed for cell growth. Bortezomib may also make tumor cells more sensitive
to radiation. Giving samarium 153 together with bortezomib may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of samarium 153 when
given together with bortezomib in treating patients with relapsed or refractory multiple
myeloma.
OBJECTIVES:
Primary
- Assess the safety and tolerability (maximum tolerated dose and dose-limiting toxicity)
of samarium Sm 153 lexidronam pentasodium and bortezomib in patients with relapsed or
refractory multiple myeloma.
Secondary
- Determine the response rate (combined complete response, partial response, and minimal
response) in patients treated with this regimen.
- Determine the time to response and the time to progression of disease in patients
treated with this regimen.
- Determine the progression-free survival and overall survival of patients treated with
this regimen.
- Assess the antitumor effects of this regimen in these patients.
OUTLINE: This is an open-label, dose-escalation study of samarium Sm 153 lexidronam
pentasodium.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and samarium Sm 153
lexidronam pentasodium IV on day 3. Treatment repeats every 8 weeks for up to 4 courses in
the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of samarium Sm 153 lexidronam pentasodium
until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which 2 of 6 patients experience dose-limiting toxicity. The MTD of
samarium Sm 153 lexidronam pentasodium is determined with 2 different doses of bortezomib.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
;
Masking: Open Label, Primary Purpose: Treatment
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