Autologous Transplant for Multiple Myeloma

This study is currently recruiting participants.
Verified May 2013 by Masonic Cancer Center, University of Minnesota
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00177047
First received: September 13, 2005
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

This is a study of a regimen of melphalan and autologous stem cells for patients with multiple myeloma. We hypothesize that this particular regimen will improve the survival of these patients.


Condition Intervention Phase
Multiple Myeloma
Procedure: Stem Cell Transplant
Drug: Cyclophosphamide + Mesna
Drug: Melphalan
Biological: Granulocyte-colony stimulating factor
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Autologous Transplantation for Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • Comparison of Percentage of Patients Achieving a Complete Response [ Time Frame: 100 Days, 6 Months, 1 Year Post Treatment ] [ Designated as safety issue: No ]

    Myeloma Response Definitions - Using International Uniform Response Criteria:

    Stringent Complete Response (sCR)requires, plus CR:

    • Normal free light chain ratio
    • Absence of clonal cells in bone marrow

    Complete Response (CR):

    • Absence of the original monoclonal paraprotein
    • <5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy
    • No increase in size or number of lytic bone lesions
    • Disappearance of soft tissue plasmacytomas.


Secondary Outcome Measures:
  • Percentage of patients with extended disease-free survival [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
    Extended disease free survival will be defined as percentage of patients surviving more than 36 months without relapse or disease progression.

  • Comparison of Overall Survival [ Time Frame: 1, 2 and 3 years ] [ Designated as safety issue: No ]
    The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate.

  • Transplant related mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    In the field of transplantation, toxicity is high and all deaths without previous relapse or progression are usually considered as related to transplantation.

  • Incidence of relapse [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The return of disease after its apparent recovery/cessation.

  • Incidence of disease progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Hematologic recovery [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
  • Time to Progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Time to relapse [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Time to attainment of CR and CR+PR [ Time Frame: During study ] [ Designated as safety issue: No ]
  • Duration of maintenance treatment [ Time Frame: During study ] [ Designated as safety issue: No ]
  • Dropout rate from maintenance therapy [ Time Frame: Post transplant phase ] [ Designated as safety issue: No ]
  • Incidence of toxicities [ Time Frame: During study ] [ Designated as safety issue: Yes ]
  • Incidence of infections [ Time Frame: During study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: January 2004
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chemotherapy and Transplant Treatment
Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m^2). Post-transplant maintenance therapy is then prescribed if appropriate.
Procedure: Stem Cell Transplant
As part of the stem cell transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover.
Other Name: Bone Marrow Transplant
Drug: Cyclophosphamide + Mesna
Cyclophosphamide: 4mg/m^2 + Mesna. Mesna is used to reduce the undesired side effects of certain chemotherapy drugs.
Other Name: Cytoxan
Drug: Melphalan
Administered intravenously 200 mg/m^2
Other Name: Alkeran
Biological: Granulocyte-colony stimulating factor
Administered intravenously 10 ug/kg/day pretransplant then 5 ug/kg/day post-transplant.
Other Name: G-CSF

Detailed Description:

Before starting treatment in this study, the bone marrow transplant (BMT) doctor will check the subject's general health. Subjects will have the following tests and evaluations to find out if they can participate:--Medical history and physical examination, including height and weight.--Blood tests (approximately 4 - 5 tablespoons) --Urine tests--Chest x-ray--Electrocardiogram (ECG or EKG)--Heart Scan (MUGA)--Pulmonary Function Test (PFT)--Bone marrow biopsies and aspirates. --If Female subjects of child-bearing age will have a serum pregnancy test performed. After eligible patients have been completely staged and exercised consent, they may undergo one cycle of chemotherapy (cyclophosphamide and Mesna) and growth factor (G-CSF) to effect cytoreduction and mobilization of PBSC for collection. All patients will receive high-dose melphalan followed by an autologous stem cell transplant (SCT). Blood tests will be performed frequently to evaluate the subject's response to treatment and possible side effects of treatment. If necessary, platelet and red cell transfusions will be given to maintain adequate levels and antibiotics will be given to treat or prevent infection. Subjects may also require intravenous nutritional support and pain medications during or after transplantation. The study coordinators will collect health information over three years. They will collect information every week for 100 days, then at 6 months, 1 year, 2 years, and 3 years.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients meeting the Durie and Salmon criteria for initial diagnosis of multiple myeloma, requiring therapy and meeting one of the following:

    • After initial therapy in either first complete or partial remission or no objective response
    • After achieving initial response and later disease progression, patient will be eligible after subsequent therapy upon achievement of either complete or partial response
  • Is not eligible or has refused any protocols of higher priority
  • 18 - 75 years of age
  • Adequate organ function defined as:

    • Hematologic: hemoglobin ≥ 8 gm/dl (untransfused), white blood cells (WBC) ≥ 3000/μl, absolute neutrophil count (ANC) ≥ 1500/μl, platelets ≥ 100,000/μl (untransfused)
    • Cardiac: no active ischemia, left ventricular ejection fraction > 45% by MUGA scan
    • Hepatic: bilirubin < 2.0 mg/dl, ALT < 3x the upper limit of normal
    • Pulmonary: FEV1-Forced Expiratory Volume in One Second AND Forced vital capacity (FVC) >50% predicted and Carbon Monoxide Diffusing Capacity (DLCO) (corrected) > 50% predicted
    • Performance status: Karnofsky performance of > 80%.
  • Free of active uncontrolled infection at the time of study entry.
  • At time of study enrollment > 4 weeks from prior myelosuppressive chemotherapy; and > 6 weeks from prior nitrosoureas.
  • Patients must exercise informed voluntary consent and sign a consent form approved by the University of Minnesota IRB: Human Subjects Committee.

Exclusion Criteria:

  • Patients will be ineligible if they have advanced myeloma refractory and unresponsive to salvage chemotherapy regimens.
  • Female patients who are pregnant (positive b-HCG) or breastfeeding will be excluded from study entry. In addition fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment, particularly after thalidomide will also be excluded from study entry.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00177047

Contacts
Contact: Timothy Krepski 612-273-2800 tkrepsk1@fairview.org

Locations
United States, Minnesota
Masonic Cancer Center, University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Brian McClune, DO    612-624-7101    bmcclune@umn.edu   
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Principal Investigator: Brian McClune, DO Masonic Cancer Center, University of Minnesota
  More Information

No publications provided

Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00177047     History of Changes
Obsolete Identifiers: NCT00293306
Other Study ID Numbers: 2004LS001, MT2003-13, 0312M54569
Study First Received: September 13, 2005
Last Updated: May 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Masonic Cancer Center, University of Minnesota:
stem cell transplantation
chemotherapy
multiple myeloma
autologous

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
Mesna
Cyclophosphamide
Melphalan
Lenograstim
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on April 22, 2014