Multiple Myeloma Clinical Trial
Official title:
Phase I Dose Escalation Trial of High Dose Melphalan Conditioning Regimen With Palifermin for Cytoprotection Followed by Autologous Peripheral Blood Stem Cell Transplantation for Multiple Myeloma
RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing.
Keratinocyte growth factors, such as palifermin, may help prevent symptoms of mucositis, or
mouth sores, in patients receiving melphalan before a peripheral stem cell transplant for
multiple myeloma.
PURPOSE: This phase I trial is studying the side effects and best dose of melphalan when
given together with palifermin in treating patients undergoing an autologous peripheral stem
cell transplant for stage II or stage III multiple myeloma.
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of high-dose melphalan when administered with
palifermin in patients undergoing autologous peripheral blood stem cell transplantation
for stage II or III multiple myeloma.
Secondary
- Assess overall response (complete and partial response and stable disease) in these
patients at 28 and 100 days post-transplantation.
- Assess the efficacy of palifermin as a cytoprotective agent in reducing incidence and
duration of mucositis in patients treated with this regimen.
- Assess patient-reported outcomes and impact of palifermin on quality of life of these
patients.
- Assess the qualitative and quantitative toxicities of this regimen in these patients.
OUTLINE: This is a dose-escalation study of melphalan. Patients are stratified according to
creatinine clearance (normal vs < 60 mL/min).
Patients receive high-dose melphalan IV on day -2 and palifermin IV on days -5 to -3 and
1-3. Patients undergo autologous peripheral blood stem cell transplantation on day 0.
In each stratum, cohorts of 3-6 patients receive escalating doses of melphalan until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients complete questionnaires about overall health, mouth and throat soreness (MTS), and
activity limitations due to MTS once daily on days -5 to 28.
After completion of study treatment, patients are followed at days 28 and 100 and then
periodically thereafter.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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