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

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Barbara Ann Karmanos Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Melphalan

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of multiple myeloma

• Stage II or III disease

• Must have undergone successful stem cell mobilization (≥ 2.0 x 10^6 CD34+ cells/kg)

• No oral lesions from any other etiology

• No unhealed mucositis from induction treatment

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%

• Amylase and lipase normal

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• AST and ALT ≤ 3 times ULN

• Creatinine normal (stratum 1 only)

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No HIV positivity

• No history of allergic reaction attributed to melphalan

• No uncontrolled illness, including, but not limited to, any of the following:

• Ongoing or active infection

• Symptomatic congestive heart failure

• Unstable angina pectoris

• Cardiac arrhythmia

• No psychiatric illness or social situation that would preclude study compliance

• No hepatitis B or C positivity

• No prior or concurrent pancreatitis

• No known sensitivity to any of the study drugs, including E. coli-derived products

PRIOR CONCURRENT THERAPY:

• Prior bone marrow or stem cell transplantation allowed

• No prior palifermin

• More than 30 days since prior investigational agents

• No concurrent dialysis

• No concurrent amifostine

• No concurrent prophylactic oral cryotherapy during melphalan administration

• No concurrent mouthwash solutions containing any of the following:

• Chlorhexidine

• Hydrogen peroxide

• Diphenhydramine hydrochloride

• No concurrent recombinant interleukin-11 or sargramostim (GM-CSF)

• No concurrent sucralfate in suspension form

• Sucralfate tablets allowed

• No concurrent povidone-iodine rinses

• No concurrent glutamine as a prophylactic agent for mucositis

• No other concurrent investigational agents

• No concurrent antithymocyte globulin suppression or alemtuzumab

• No concurrent rituximab