Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Supportive care, Treatment Active 18 and over NCI WSU-2006-119 WSU 2006-119, NCT00482846

Objectives

Primary

1. 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

1. Assess overall response (complete and partial response and stable disease) in these patients at 28 and 100 days post-transplantation.
2. Assess the efficacy of palifermin as a cytoprotective agent in reducing incidence and duration of mucositis in patients treated with this regimen.
3. Assess patient-reported outcomes and impact of palifermin on quality of life of these patients.
4. Assess the qualitative and quantitative toxicities of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Diagnosis of multiple myeloma
  • Stage II or III disease



• Must have undergone successful stem cell mobilization (≥ 2.0 x 10⁶ CD34+ cells/kg)



• No oral lesions from any other etiology



• No unhealed mucositis from induction treatment

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

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

Expected Enrollment

Outcomes

Maximum tolerated dose of melphalan

Dose-limiting toxicity
Mucositis and diarrhea
Overall response
Reduction in incidence and duration of mucositis
Quality of life

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.

Trial Contact Information

Trial Lead Organizations

Barbara Ann Karmanos Cancer Institute

Muneer Abidi, MD, Principal investigator		Ph: 313-576-8713; 800-527-6266 Email: abidim@karmanos.org

U.S.A.
Michigan
	Detroit
	Barbara Ann Karmanos Cancer Institute
		Clinical Trials Office - Barbara Ann Karmanos Cancer Institute	Ph:  313-576-9363
	Sinai-Grace Hospital
		Muneer Abidi	Ph:  313-576-8713

Registry Information
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
Trial Start Date		2007-05-21
Trial Completion Date		2009-01-01 (estimated)
Registered in ClinicalTrials.gov		NCT00482846
Date Submitted to PDQ		2007-05-03
Information Last Verified		2008-08-23
NCI Grant/Contract Number		CA22453

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