A Three-Stage Phase I/II Dose-Escalation Study of High-Dose Melphalan with Palifermin for Patients with Multiple Myeloma

Phase 1

• Conditions: Multiple myeloma; Cancer - Myeloma

• Registration Number: ACTRN12606000433505
• Lead Sponsor: Australasian Leukaemia and Lymphoma Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-10-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Diagnosis of multiple myeloma.-No more than 12 months total prior standard-dose chemotherapy.-No previous high-dose chemotherapy or autologous transplantation procedure.-Normal liver function->2.0 x 106 CD34+ cells/kg bodyweight available for reinfusion.-ECOG performance status <3-Have achieved less than Complete Response with a recognised induction protocol-No contraindication to the use of any of the study drugs, including knownsensitivity to E coli-derived preparations.-Written informed consent.

Exclusion Criteria

Patients with monoclonal gammopathy of undetermined significance-Patients whose general condition makes them unsuitable for intensivetreatment-Active infections or other illnesses that precludes chemotherapyadministration or patient compliance.-Serum creatinine >0.18mMol/L.-Pregnant or lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the maximum tolerated dose of intravenous melphalan when it is used in combination with palifermin for the treatment of multiple myeloma patients who fail to achieve complete remission with pre-transplant induction therapy. The occurrence of 2 grade 4 toxicities within a 4 or 8 person cohort will establish the MTD as the dose level below that cohort's dose level.[Patients will be observed for 4 weeks post transplant to identify any grade 4 non-haematological toxicity.]

Secondary Outcome Measures

Name	Time	Method
To determine the complete response rate achieved with the maximum tolerated dose of intravenous melphalan when it is used in combination with palifermin for the treatment of multiple myeloma patients who fail to achieve either 1) partial remission or 2) complete remission with pre-transplant induction therapy.[];To characterize the rate of neutrophil engraftment following high-dose melphalan conditioned autologous stem cell transplant in patients with multiple myeloma being treated with palifermin. [];Disease response will be measured at 3months post transplant when a bone marrow, biochemistry and serum and urine paraprotein assessments will be performed.[];Neutrophil engraftment will be monitored with daily blood counts, post transplant until engraftment (neutrophils greater than 0.5x10^9/L) is established.[]