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NCT00217438 · REGISTRY CONDITION SEARCH

Melphalan and Amifostine Followed By One or Two Autologous or Syngeneic Stem Cell Transplants and Maintenance Therapy in Treating Patients With Stage II-III Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2015-08-21

RATIONALE: Giving chemotherapy drugs, 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. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy. Giving chemotherapy with a peripheral stem cell transplant once or twice, using stem cells from the patient or an identical brother or sister, may allow more chemotherapy to be given so more cancer cells are killed. Giving maintenance therapy after a stem cell transplant may kill any cancer cells that remain. It is not yet known which dose of melphalan is more effective in treating multiple myeloma (MM). PURPOSE: This randomized phase III trial is studying two different doses of melphalan to compare how well they work when given together with amifostine followed by one or two autologous or syngeneic stem cell transplants and maintenance therapy in treating patients with stage II-III MM

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

CR and Near CR Rates

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outcome · POSTED

Relative Toxicities Between Melphalan 280 mg/m^2 or Melphalan 200 mg/m^2

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Patients who have MM undergoing autologous or syngeneic hematopoietic transplantation * Patients must meet Salmon and Durie criteria for initial diagnosis of MM * Transplant will be offered to patients with stage II or III MM * Measurable disease, defined as serum monoclonal protein \>= 0.2 g/dl or Bence Jones protein \>= 200 mg/24 h * Karnofsky \>= 70 or Eastern Cooperative Oncology Group (ECOG) 0-2 * Life expectancy is not severely limited by concomitant illness * Left ventricular ejection fraction \>= 50% * No uncontrolled arrhythmias or symptomatic cardiac disease * Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and diffusion capacity of carbon monoxide (DLCO) \>= 50% * No symptomatic pulmonary disease * Human immunodeficiency virus (HIV) negative * Bilirubin \< 2 mg/dl * Serum glutamic pyruvate transaminase (SGPT) \< 2.5 x normal * Creatinine clearance \>= 60 cc/min, estimated or measured * Signed informed consent Exclusion Criteria: * Pregnant or lactating females * Uncontrolled infection * Planned tandem autologous/reduced intensity allograft * Insufficient PBSC for an autologous transplant (\< 3.0 x 10\^6 CD34+ cells/kg total) * Prior autologous transplant * Non-secretory myeloma and patients who are in a complete response or near complete response after conventional therapy * Patients unwilling to practice adequate forms of contraception if clinically indicated * Male patients on study need to be consulted to use latex condoms, even if they have had a vasectomy, every time they have sex with a woman who is able to have children * Patients with history of seizures * Patients receiving antihypertensive therapy that cannot be stopped for 24 hours preceding amifostine treatment
healthy Volunteers
false
maximum Age
70 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    INDUCTION THERAPY: Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2. AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0. Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT. Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy.
    intervention Names
    1. Drug: melphalan
    2. Drug: amifostine trihydrate
    3. Procedure: peripheral blood stem cell transplantation
    4. Genetic: fluorescence in situ hybridization
    5. Procedure: bone marrow ablation with stem cell support
    label
    Arm I (high dose melphalan, amifostine trihydrate, transplant)
    type
    EXPERIMENTAL
  2. description
    INDUCTION THERAPY: Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose. AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0. Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT. Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy.
    intervention Names
    1. Drug: melphalan
    2. Drug: amifostine trihydrate
    3. Procedure: peripheral blood stem cell transplantation
    4. Genetic: fluorescence in situ hybridization
    5. Procedure: bone marrow ablation with stem cell support
    label
    Arm II (low dose melphalan, amifostine trihydrate, transplant)
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Arm I (high dose melphalan, amifostine trihydrate, transplant)
    2. Arm II (low dose melphalan, amifostine trihydrate, transplant)
    description
    Given IV
    name
    melphalan
    other Names
    1. Alkeran
    2. CB-3025
    3. L-PAM
    4. L-phenylalanine mustard
    5. L-Sarcolysin
    type
    DRUG
  2. arm Group Labels
    1. Arm I (high dose melphalan, amifostine trihydrate, transplant)
    2. Arm II (low dose melphalan, amifostine trihydrate, transplant)
    description
    Given IV
    name
    amifostine trihydrate
    other Names
    1. ethiofos
    2. Ethyol
    3. gammaphos
    4. WR-2721
    type
    DRUG
  3. arm Group Labels
    1. Arm I (high dose melphalan, amifostine trihydrate, transplant)
    2. Arm II (low dose melphalan, amifostine trihydrate, transplant)
    description
    Undergo PBSCT
    name
    peripheral blood stem cell transplantation
    other Names
    1. PBPC transplantation
    2. PBSC transplantation
    3. peripheral blood progenitor cell transplantation
    4. transplantation, peripheral blood stem cell
    type
    PROCEDURE
  4. arm Group Labels
    1. Arm I (high dose melphalan, amifostine trihydrate, transplant)
    2. Arm II (low dose melphalan, amifostine trihydrate, transplant)
    description
    Correlative study
    name
    fluorescence in situ hybridization
    other Names
    1. fluorescence in situ hybridization (FISH)
    type
    GENETIC
  5. arm Group Labels
    1. Arm I (high dose melphalan, amifostine trihydrate, transplant)
    2. Arm II (low dose melphalan, amifostine trihydrate, transplant)
    description
    Undergo transplant
    name
    bone marrow ablation with stem cell support
    type
    PROCEDURE
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
130
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Per modified European Group for Blood and Marrow Transplant (EBMT) response criteria for definition of response in patients with multiple myeloma treated by high-dose therapy and stem cell transplantation: Complete Response (CR): Complete disappearance of all clinically measurable disease, complete response requires negative tests for monoclonal proteins in serum and urine by immunofixation, no monoclonal plasma cells in marrow specimen by flow cytometry and no evidence of progressive bone disease by skeletal survey. "Near" Complete Response (nCR): Less than 0.1 gram/dL monoclonal protein detectable in serum by standard protein electrophoresis and less than 50 mg monoclonal protein detectable in urine on 24 hour collection. Less than 5% monoclonal plasma cells detectable in bone marrow by immunohistochemistry. No evidence of progressive bone disease by skeletal survey.
    measure
    CR and Near CR Rates
    time Frame
    Up to 120 days after transplant
secondary Outcomes
  1. description
    Number of Grade 3-4 adverse events observed in each group from enrollment through the Day 80-120 evaluation. Grade 3-4 events are defined by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
    measure
    Relative Toxicities Between Melphalan 280 mg/m^2 or Melphalan 200 mg/m^2
    time Frame
    Up to day 56 after transplant
Full study description
brief Summary
RATIONALE: Giving chemotherapy drugs, 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. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy. Giving chemotherapy with a peripheral stem cell transplant once or twice, using stem cells from the patient or an identical brother or sister, may allow more chemotherapy to be given so more cancer cells are killed. Giving maintenance therapy after a stem cell transplant may kill any cancer cells that remain. It is not yet known which dose of melphalan is more effective in treating multiple myeloma (MM). PURPOSE: This randomized phase III trial is studying two different doses of melphalan to compare how well they work when given together with amifostine followed by one or two autologous or syngeneic stem cell transplants and maintenance therapy in treating patients with stage II-III MM
detailed Description
PRIMARY OBJECTIVES: I. Compare the complete response (CR) and near CR rate in patients undergoing autologous stem cell transplant (ASCT) using melphalan 280 mg/m\^2 or melphalan 200 mg/m\^2. SECONDARY OBJECTIVES: I. Compare toxicities between patients receiving amifostine and melphalan 280 mg/m\^2 or melphalan 200 mg/m\^2. OUTLINE: Patients are randomized to 1 of 2 treatment arms. INDUCTION THERAPY: ARM I (HIGH DOSE MELPHALAN AND AMIFOSTINE): Patients receive amifostine intravenously (IV) over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2. ARM II (LOW DOSE MELPHALAN AND AMIFOSTINE): Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose. AUTOLOGOUS OR SYNGENEIC PERIPHERAL BLOOD STEM CELL TRANSPLANTATION (PBSCT): At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0. Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT. Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy. After completion of study treatment, patients are followed up every 3 months for 5 years.
Source references
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice