NCT00482846

Melphalan and Palifermin in Treating Patients Undergoing An Autologous Peripheral Stem Cell Transplant for Stage II or III Multiple Myeloma

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Mucositis
• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	Palifermin	Palifermin 60 mcg/kg/d of the actual body weight unless actual body weight is \>40% of the Ideal body weight (IBW), then adjusted body weight (AdBW) will be used for dose calculations - administered on Day - 5,-4, - 3 and then repeated on Day +1, +2 and +3
DRUG	melphalan	Dose of Melphalan + Palifermin (Normal Renal Function): All given on Day -2: Dose Level 1- 200 mg/m2 I.V; Dose Level 2- 220 mg/m2 I.V; Dose Level 3- 240 mg/m2 I.V; Dose Level 4- 260 mg/m2 I.V; Dose Level 5- 280 mg/m2 I.V; Dose of Melphalan + Palifermin (Renal Dysfunction CrCl. \<60)adm. via I.V.: Dose Level 1- 140 mg/m2; Dose Level 2- 160 mg/m2; Dose Level 3- 180 mg/m2; Dose Level 4- 200 mg/m2; Dose Level 5- 220 mg/m2;
OTHER	questionnaire administration	Day -5 to Day +28
PROCEDURE	autologous peripheral blood stem cell transplantation	Day 0
OTHER	quality-of-life assessment	Day -5 to Day +28

Timeline

• Start date: 2007-06-01
• Primary completion: 2011-10-01
• Completion: 2012-09-01
• First posted: 2007-06-05
• Last updated: 2014-04-15

Locations

1 site across 1 country: United States