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Autologous Transplant for Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00177047
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : December 3, 2020
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Brief Summary:
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 or disease Intervention/treatment Phase
Multiple Myeloma Procedure: Stem Cell Transplant Drug: Cyclophosphamide + Mesna Drug: Melphalan Biological: Granulocyte-colony stimulating factor Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 363 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Transplantation for Multiple Myeloma
Actual Study Start Date : April 20, 2004
Actual Primary Completion Date : August 1, 2020
Actual Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Comparison of Percentage of Patients Achieving a Complete Response [ Time Frame: 100 Days, 6 Months, 1 Year Post Treatment ]

    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 :
  1. Percentage of patients with extended disease-free survival [ Time Frame: 36 Months ]
    Extended disease free survival will be defined as percentage of patients surviving more than 36 months without relapse or disease progression.

  2. Comparison of Overall Survival [ Time Frame: 1, 2 and 3 years ]
    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.

  3. Transplant related mortality [ Time Frame: 1 year ]
    In the field of transplantation, toxicity is high and all deaths without previous relapse or progression are usually considered as related to transplantation.

  4. Incidence of relapse [ Time Frame: 1 year ]
    The return of disease after its apparent recovery/cessation.

  5. Incidence of disease progression [ Time Frame: 1 year ]
  6. Hematologic recovery [ Time Frame: Day 42 ]
  7. Time to Progression [ Time Frame: 1 year ]
  8. Time to relapse [ Time Frame: 1 year ]
  9. Time to attainment of CR and CR+PR [ Time Frame: During study ]
  10. Duration of maintenance treatment [ Time Frame: During study ]
  11. Dropout rate from maintenance therapy [ Time Frame: Post transplant phase ]
  12. Incidence of toxicities [ Time Frame: During study ]
  13. Incidence of infections [ Time Frame: During study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00177047

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United States, Minnesota
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
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Principal Investigator: Claudio Brunstein, MD, PhD Masonic Cancer Center, University of Minnesota
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Responsible Party: Masonic Cancer Center, University of Minnesota Identifier: NCT00177047    
Obsolete Identifiers: NCT00293306
Other Study ID Numbers: 2004LS001
MT2003-13 ( Other Identifier: Blood and Marrow Transplantation Program )
0312M54569 ( Other Identifier: IRB, University of Minnesota )
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: December 3, 2020
Last Verified: December 2020
Keywords provided by Masonic Cancer Center, University of Minnesota:
stem cell transplantation
multiple myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Adjuvants, Immunologic