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NCT00941720 · REGISTRY CONDITION SEARCH

Busulfan, Cyclophosphamide, and Autologous Stem Cell Transplant in Treating Patients With 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
PHASE2
Status at capture
COMPLETED
Registry last update
2020-07-24

RATIONALE: Giving high-dose chemotherapy before an autologous stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. An autologous stem cell transplant may be able to replace the blood-forming cells that were destroyed by the chemotherapy. PURPOSE: This phase II trial is studying how well giving busulfan together with cyclophosphamide followed by an autologous stem cell transplant works in treating patients with multiple myeloma.

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

Relapse-free Survival

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outcome · POSTED

Overall Survival

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outcome · POSTED

Pulmonary Toxicity

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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 with a diagnosis of plasma cell myeloma * Patients with cardiac ejection fraction \>= 45% or clearance by Cleveland Clinic Faculty (CCF) cardiologist * Patients with diffusion capacity of carbon monoxide (DLCO) \>= 45% predicted or clearance by CCF pulmonologist * Patient with previously harvested peripheral blood progenitor cells with a minimum of 2 x 10\^6 CD 34+ cells/kg harvested EXCLUSION CRITERIA: * Patients receiving total body irradiation * Non-myeloablative/reduced-intensity conditioning * Pregnant and breast feeding patients * Human immunodeficiency virus (HIV) positive * Patients with serum creatinine \> 2.0 * Prior Hematopoietic Stem Cell (HSC) transplant
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Drug: busulfan
    2. Drug: cyclophosphamide
    3. Procedure: autologous hematopoietic stem cell transplantation
    label
    Busulfan Treatment
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Busulfan Treatment
    description
    IV busulfan 0.8 mg/kg every 6 hours x 16 doses
    name
    busulfan
    other Names
    1. BSF
    2. BU
    3. Misulfan
    4. Mitosan
    5. Myeloleukon
    6. Myelosan
    type
    DRUG
  2. arm Group Labels
    1. Busulfan Treatment
    description
    IV cyclophosphamide 60 mg/kg over 4 hours x 2 days
    name
    cyclophosphamide
    other Names
    1. CPM
    2. CTX
    3. Cytoxan
    4. Endoxan
    5. Endoxana
    6. Enduxan
    type
    DRUG
  3. arm Group Labels
    1. Busulfan Treatment
    description
    infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0
    name
    autologous hematopoietic stem cell transplantation
    type
    PROCEDURE
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
71
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Number of participants without progressive disease at the end of the study period, using the definitions for complete response, partial response and progressive disease from the International Myeloma Working Group .
    measure
    Relapse-free Survival
    time Frame
    at 6 months
  2. description
    Number of patients alive at the end of the study period
    measure
    Overall Survival
    time Frame
    at 6 months
secondary Outcomes
  1. description
    Toxicity criteria will be assessed and graded according to the National Cancer Institute (NCI) Common Terminology Criteria (CTC) v3.0. Estimated using exact 95% binomial confidence intervals.
    measure
    Pulmonary Toxicity
    time Frame
    At 6 months
Full study description
brief Summary
RATIONALE: Giving high-dose chemotherapy before an autologous stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. An autologous stem cell transplant may be able to replace the blood-forming cells that were destroyed by the chemotherapy. PURPOSE: This phase II trial is studying how well giving busulfan together with cyclophosphamide followed by an autologous stem cell transplant works in treating patients with multiple myeloma.
detailed Description
OBJECTIVES: Primary * To compare relapse-free survival and overall survival of patients with multiple myeloma treated with IV busulfan vs historical control patients treated with oral busulfan when administered with cyclophosphamide as a conditioning regimen prior to autologous hematopoietic stem cell transplantation. Secondary * To compare pulmonary toxicity rates of IV busulfan vs oral busulfan when administered with cyclophosphamide as a conditioning regimen prior to autologous hematopoietic stem cell transplantation. OUTLINE: Patients receive high-dose busulfan IV every 6 hours on days -8 to -4 and high-dose cyclophosphamide IV over 4 hours on days -3 and -2. Patients undergo autologous hematopoietic stem cell transplantation on day 0. After completion of study treatment, patients are followed up periodically.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-a690f75056d8ac981921
      requested nct id
      NCT00941720
      primary nct id
      NCT00941720
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      28f4d683d5c7534e97d76a26257431e6630fd2544c4af31ce0d00a44c658a0f7
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-a690f75056d8ac981921
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00941720
      occurrences
      1. context exact
        NCT00941720
        end
        11
        exact text
        NCT00941720
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      source json pointer
      /studies/449/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      cc2756936e24c416ea6ff98d6353118913df44bb7fd74fe3b2d8d55a999af110

    Preserved source evidence · Not medical advice