Melphalan & Palifermin Followed by Peripheral Blood Stem Cell Transplant in Treating Pts w/Stage II-III Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Muneer Abidi, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT01654744
First received: July 30, 2012
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

This pilot phase I trial studies the side effects and the best dose of melphalan when given together with palifermin followed by peripheral blood stem cell transplant (PBSCT) in treating patients with stage II-III multiple myeloma. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Palifermin may help prevent symptoms of mucositis, or mouth sores, in patients receiving melphalan followed by a PBSCT


Condition Intervention Phase
Stage II Multiple Myeloma
Stage III Multiple Myeloma
Drug: melphalan
Biological: palifermin
Procedure: peripheral blood stem cell transplantation
Procedure: autologous hematopoietic stem cell transplantation
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • Independent determination of the MTD of high-dose melphalan in Strata I and II [ Time Frame: Day -2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dose-limiting toxicity of palifermin according to Common Terminology Criteria v 3.0 [ Time Frame: Up to 20 days after completion of treatment ] [ Designated as safety issue: Yes ]
  • Grade IV mucositis and diarrhea related to melphalan [ Time Frame: Days -2, 0, and 1-28 ] [ Designated as safety issue: Yes ]
  • Overall response [ Time Frame: Days 28 and 100 ] [ Designated as safety issue: No ]
  • Reduction in the incidence and duration of grade III/IV mucositis [ Time Frame: Days -5 to 28 ] [ Designated as safety issue: No ]
  • Quality of life assessments [ Time Frame: Days -5, 0, and 1-28 ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: May 2007
Study Completion Date: November 2013
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (high-dose melphalan, autologous PBSCT)

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

TRANSPLANTATION: Patients undergo autologous PBSCT on day 0.

Drug: melphalan
Given IV
Other Names:
  • Alkeran
  • CB-3025
  • L-PAM
  • L-phenylalanine mustard
  • L-Sarcolysin
Biological: palifermin
Given IV
Other Names:
  • growth factor, recombinant human keratinocyte
  • Kepivance
  • keratinocyte growth factor, recombinant human
  • recombinant human keratinocyte growth factor
  • rhKGF
Procedure: peripheral blood stem cell transplantation
Undergo autologous PBSCT
Other Names:
  • PBPC transplantation
  • PBSC transplantation
  • peripheral blood progenitor cell transplantation
  • transplantation, peripheral blood stem cell
Procedure: autologous hematopoietic stem cell transplantation
Undergo autologous PBSCT

Detailed Description:

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01654744

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Principal Investigator: Muneer Abidi Barbara Ann Karmanos Cancer Institute
  More Information

No publications provided

Responsible Party: Muneer Abidi, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT01654744     History of Changes
Other Study ID Numbers: 2006-119, NCI-2011-00663
Study First Received: July 30, 2012
Last Updated: January 20, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Mitogens
Melphalan
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 20, 2014