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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

Phase 1
18 Years
Open (Enrolling)
Stage II Multiple Myeloma, Stage III Multiple Myeloma

Thank you

Trial Information

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


I. To determine the maximum-tolerated dose (MTD) of melphalan in patients with normal and
abnormal renal function undergoing autologous stem cell transplants for myeloma when treated
with palifermin to prevent mucositis.


I. To assess overall response (compete response [CR], partial response [PR], stable disease
[SD]) at D+28 and D+100 after autologous transplant when treated with combination of
palifermin and Melphalan.

II. To evaluate the efficacy of Palifermin as a cytoprotective agent in reducing incidence
and duration of Grade 3 and 4 mucositis due to high dose Melphalan.

III. To assess patient reported outcomes and impact of using palifermin on quality of life
in the post transplant duration.

IV. To assess the qualitative and quantitative toxicities associated with this regimen.

OUTLINE: This is a dose-escalation study of melphalan.

CONDITIONING REGIMEN: Patients receive high-dose melphalan intravenously (IV) on day -2 and
palifermin IV on days -5 to -3 and 1-3.

TRANSPLANTATION: Patients undergo autologous PBSCT on day 0.

After completion of study treatment, patients are followed up at days 28 and 100, and then
periodically thereafter.

Inclusion Criteria:

Patients with Stage II/III myeloma who meet the institutional criteria for undergoing
high-dose chemotherapy and autologous transplant for multiple myeloma will be eligible for
this study; patients in the abnormal renal function group should have no other organ
dysfunction that does not meet institutional criteria Minimum of 2.0 x 10^6 cluster of
differentiation (CD) 34+ cells/kg cryopreserved and to be transplanted Eastern Cooperative
Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) Women of child-bearing
potential and men must agree to use adequate contraception (hormonal or barrier method of
birth control) prior to study entry and for the duration of study participation; should a
woman become pregnant or suspect if she is pregnant while participating in this study, she
should inform her physician immediately Ability to understand and the willingness to sign
a written informed consent Women patients must have a negative human immunodeficiency
virus (HIV) and pregnancy test; these tests will be performed with pre-transplant work up
for eligibility/clearance Patients in Stratum 1 should have a normal serum creatinine and
a normal amylase and lipase in both Strata at baseline Patients with prior bone
marrow/stem cell transplantation will be eligible for the study

Exclusion Criteria:

Baseline oral lesions from any other etiology or unhealed mucositis from induction
treatment Patients may not be receiving any other investigational agents 30 days prior to
registration on this protocol History of allergic reactions attributed to Melphalan Total
bilirubin > 1.5 x upper limit of normal Transaminase > 3 x normal Uncontrolled inter
current illness including, but not limited to ongoing or active infection, symptomatic
congestive heart failure, unstable angina pectoris, cardiac arrhythmia, seropositive for
HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), or psychiatric illness/social
situations that would limit with study requirements Patients who do not meet institutional
criteria for autologous stem cell transplant (Exception: creatinine clearance [CrCl]: < 60
for stratum 2) Patients undergoing dialysis will not be allowed on this study History of
or current diagnosis of pancreatitis Subject or partner of subject is not using or refuses
to use adequate contraceptive precautions Subject has known sensitivity to any of the
products to be administered during dosing including Escherichia coli-derived products
Prior use of palifermin

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Independent determination of the MTD of high-dose melphalan in Strata I and II

Outcome Time Frame:

Day -2

Safety Issue:


Principal Investigator

Muneer Abidi

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

May 2007

Completion Date:

March 2014

Related Keywords:

  • Stage II Multiple Myeloma
  • Stage III Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201