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Completed

NCT Number: NCT00177047

Autologous Transplant for Multiple Myeloma

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stem Cell Transplant

Procedure

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 names: Bone Marrow Transplant

Cyclophosphamide + Mesna

Drug

Cyclophosphamide: 4mg/m^2 + Mesna. Mesna is used to reduce the undesired side effects of certain chemotherapy drugs.

Other names: Cytoxan

melphalan

Drug

Administered intravenously 200 mg/m^2

Other names: Alkeran

Granulocyte-colony stimulating factor

Biological

Administered intravenously 10 ug/kg/day pretransplant then 5 ug/kg/day post-transplant.

Other names: G-CSF

Primary outcomes

  1. Number of Participants Achieving a Complete Response

    Time frame: 100 Days post transplant

    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.

  2. Number of Participants Achieving a Complete Response

    Time frame: 6 months post transplant

    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.

  3. Number of Participants Achieving a Complete Response

    Time frame: 12 months post transplant

    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 outcomes

  1. Number 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. Number of Participants With Overall Survival

    Time frame: 1 year

    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. Number of Participants With Overall Survival

    Time frame: 2 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.

  4. Number of Participants With Overall Survival

    Time frame: 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.

  5. Count of Participants Experiencing 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.

  6. Number of Participants Experiencing Incidence of Relapse

    Time frame: 1 year

    The return of disease after its apparent recovery/cessation.

  7. Number of Participants With Disease Progression

    Time frame: 1 year

    Myeloma Response Definitions - Using International Uniform Response Criteria:

    Progressive Disease (PD)

    For patients not in CR or sCR, progressive disease requires one or more of the following:

    • >25% increase in the level of the serum monoclonal paraprotein, which must also be an absolute increase of at least 0.5 g/dL.
    • >25% increase in 24-hour urine protein electrophoresis, which must also be an absolute increase of at least 200 mg/24 hours.
    • Absolute increase in the difference between involved and uninvolved FLC levels (absolute increase must be >10 mg/dl), only in patients without measurable paraprotein in the serum and urine.
    • >25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10%.
    • Definite increase in the size of existing bone lesions or soft tissue plasmacytomas.

  8. Time to Progression

    Time frame: 1 year

    Mean number of days among patients progressing

  9. Time to Relapse

    Time frame: 1 year

    Mean number of days among patients relapsing

  10. Number of Participants With Absolute Neutrophil Recovery

    Time frame: Day 42

    Hematologic recovery is defined by absolute neutrophil count (ANC) >2500/μl and platelets > 100,000/μl

  11. Time to Attainment of CR

    Time frame: 12 months post transplant

    Mean (STD) among patients achieving complete remission (CR)

    Myeloma Response Definitions - Using International Uniform Response Criteria:

    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

  12. Time to Attainment of CR+PR

    Time frame: 12 months post transplant

    Mean (STD) among patients achieving complete remission (CR) and partial remission (PR)

    Myeloma Response Definitions - Using International Uniform Response Criteria:

    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.

    Partial Response (PR):

    • Greater than or equal to 50% reduction in the level of the serum monoclonal paraprotein and/or reduction in 24 hour urinary monoclonal paraprotein either by greater than or equal to 90% or to <200 mg/24 hours in light chain disease.
    • If the only measurable non-bone marrow parameter is FLC, greater than or equal to 50% reduction in the difference between involved and uninvolved FLC levels or a 50% decrease in level

  13. Duration of Maintenance Treatment

    Time frame: During study

  14. Dropout Rate From Maintenance Therapy

    Time frame: Post transplant phase

  15. Number of Participants With Toxicities

    Time frame: By first 100 days

    Occurrence of toxicities by first 100 days of transplant

  16. Number of Participants With Infections

    Time frame: By first 100 days

    Occurrence of infections in the patients by the first 100 days of transplant

Sponsors and collaborators

Lead sponsor

Masonic Cancer Center, University of Minnesota

Other

Registry information

Official study title

Autologous Transplantation for Multiple Myeloma

Important dates

Study start
2004
Primary completion
2020
Study completion
2020
First posted
Sep 15, 2005
Registry last updated
Nov 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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