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Autologous Transplant for Multiple Myeloma
This study is currently recruiting participants.
Verified by Masonic Cancer Center, University of Minnesota, April 2009
First Received: September 13, 2005   Last Updated: April 21, 2009   History of Changes
Sponsored by: Masonic Cancer Center, University of Minnesota
Information provided by: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00177047
  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, melphalan
Phase II
Phase III

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Multiple Myeloma
Drug Information available for: Cyclophosphamide Melphalan Sarcolysin Melphalan hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Autologous Transplantation for Multiple Myeloma

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

Primary Outcome Measures:
  • percent of patients achieving complete response (CR) to the total therapy [ Time Frame: Day +100, 6 months and 1 year post transplant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • A second major outcome will be disease-free survival. Disease-free survival will be estimated by the Kaplan-Meier method. [ Time Frame: 36 months without relapse or disease progression ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2004
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Drug: cyclophosphamide, melphalan
    Cyclophosphamide: This treatment can produce nausea, vomiting, or intestinal upset, mouth sores, hair loss, infertility and lowering of blood counts leading to vulnerability to infections or bleeding and to possible need for blood transfusions. Rarely patients get bladder problems with pain or bleeding during urination. Melphalan: The most common side effect in patients who have received melphalan has been nausea and vomiting (mild to moderate), loss of appetite (mild), diarrhea and skin rash. Side effects that occur several days or a week later include low blood count, mouth sores, temporary hair loss, fatigue and poor appetite. Mouth sores which sometimes extend into the throat or esophagus can be painful, and some patients may require 7 to 10 days of morphine or a similar medication to control the discomfort. In rare instances, melphalan can cause lung damage or a secondary cancer.
Detailed Description:

Before starting treatment in this study, the 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 will 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 SCT. Patients will then receive two additional medications (dexamethasone and thalidomide) given by mouth. 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:   up to 70 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.
  • All patients with multiple myeloma requiring therapy.
  • Patients less than or equal to 70 years of age.
  • Patients will be eligible after initial therapy in either first complete or partial remission or if no objective response is achieved.
  • Patients achieving initial response and later disease progression will be eligible after subsequent therapy upon achievement of either complete or partial response.
  • Patients will be ineligible if they have advanced myeloma refractory to salvage chemotherapy regimens.
  • To be eligible, patients must have adequate: cardiac function (no active ischemia, left ventricular ejection fraction > 45% by MUGA scan); renal function (creatinine clearance > 40 ml/min); liver function (bilirubin < 2.0 mg/dl, ALT < 3x the upper limit of normal); adequate pulmonary function (FEV1 AND FVC >50% predicted and DLCO (corrected) > 50% predicted; and Karnofsky performance of > 80%.
  • Patients must be free of active uncontrolled infection at the time of study entry.
  • Patients must have adequate hematologic function manifest as hemoglobin > 8 gm/dl (untransfused); WBC > 3000/ml; absolute neutrophil count (ANC) > 1500/ml; and platelets > 100,000/ml (untransfused).
  • At study entry patients must be > 4 weeks from prior myelosuppressive chemotherapy; and > 6 weeks from prior nitrosoureas.
  • 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 4 weeks following completion of maintenance therapy, will also be excluded from study entry.
  • 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: Mukta Arora, M.D. 612-624-5620 arora005@umn.edu

Locations
United States, Minnesota
Masonic Cancer Center, University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Mukta Arora, M.D.     612-624-5620     arora005@umn.edu    
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Principal Investigator: Mukta Arora, MD Masonic Cancer Center, University of Minnesota
  More Information

No publications provided

Responsible Party: Masonic Cancer Center, University of Minnesota ( Mukta Arora, MD )
Study ID Numbers: 0312M54569, MT2003-13, 2004LS001
Study First Received: September 13, 2005
Last Updated: April 21, 2009
ClinicalTrials.gov Identifier: NCT00177047     History of Changes
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Morphine
Melphalan
Immunoproliferative Disorders
Immunologic Factors
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Cyclophosphamide
Hemostatic Disorders
Immunosuppressive Agents
Multiple Myeloma
Hemorrhagic Disorders
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Lymphoproliferative Disorders
Alkylating Agents
Neoplasms, Plasma Cell

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

ClinicalTrials.gov processed this record on May 07, 2009