Skip to content
Triangle logo TriangleGet started
← Study library

NCT00040937 · REGISTRY CONDITION SEARCH

S0204 Thalidomide, Chemotherapy, and Peripheral 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
2016-12-08

RATIONALE: Thalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Giving thalidomide before and after peripheral stem cell transplant may be effective in treating newly diagnosed multiple myeloma. PURPOSE: This phase II trial is studying how well giving thalidomide with chemotherapy and peripheral stem cell transplant work in treating patients with newly diagnosed 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

→

baseline

Baseline characteristics

→

outcome · POSTED

Assess Toxicity of Thalidomide/Dexamethasone as a Pre-transplant Induction Regimen.

→

outcome · POSTED

Overall Survival

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: * Newly diagnosed multiple myeloma requiring treatment * Smoldering myeloma with evidence of progressive disease requiring chemotherapy * More than 25% increase in M component levels and/or Bence-Jones excretion or symptom development * Non-secretory patients with at least 30% bone marrow plasmacytosis * No IgM peaks unless there is evidence of more than 30% bone marrow plasmacytosis or more than 3 lytic lesions PATIENT CHARACTERISTICS: Age * 18 to 65 Performance status * Zubrod 0-2 OR * Zubrod 3-4 based solely on bone pain Life expectancy * Not specified Hematopoietic * No untreated, unresolved symptomatic hyperviscosity Hepatic * Hepatitis B negative Renal * Creatinine no greater than 3 mg/dL if in renal failure and on dialysis (after hydration and/or correction of hypercalcemia) Cardiovascular * No history of chronic cerebrovascular accident * No myocardial infarction within the past 6 months * No unstable angina * No congestive heart failure that is difficult to control * No uncontrollable hypertension * No cardiac arrhythmia that is difficult to control Pulmonary * No history of chronic obstructive or chronic restrictive pulmonary disease * No untreated, unresolved pneumonia * Pulmonary function tests (PFTs) at least 50% of predicted * DLCO at least 50% of predicted * Arterial partial pressure of oxygen greater than 70 if unable to complete PFTs due to bone pain or fracture Other * HIV negative * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No untreated, unresolved pathologic fractures * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use at least 2 highly effective methods of contraception for 4 weeks before, during, and for at least 4 weeks after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No more than 8 weeks of prior thalidomide therapy Chemotherapy * No prior chemotherapy for this disease Endocrine therapy * Prior steroid therapy allowed provided treatment duration was no more than 2 weeks Radiotherapy * No prior radiotherapy to more than 50% of the pelvis Surgery * Not specified
healthy Volunteers
false
maximum Age
65 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    thalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance
    intervention Names
    1. Biological: filgrastim
    2. Biological: sargramostim
    3. Drug: cyclophosphamide
    4. Drug: dexamethasone
    5. Drug: melphalan
    6. Drug: prednisone
    7. Drug: thalidomide
    8. Procedure: peripheral blood stem cell transplantation
    label
    treatment arm
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. treatment arm
    description
    PBSC collection: 10 mcg/kg SQ days 1-10
    name
    filgrastim
    other Names
    1. G-CSF
    type
    BIOLOGICAL
  2. arm Group Labels
    1. treatment arm
    description
    PBSC collection: 500 mcg/m2 SQ day 1 through last apheresis 1st and 2nd trans: 500 mcg SC or IV days 6-WBC recovery
    name
    sargramostim
    other Names
    1. GM-CSF
    type
    BIOLOGICAL
  3. arm Group Labels
    1. treatment arm
    description
    PBSC collection: 1 mg/m2 IV over 45-60 mins day 0
    name
    cyclophosphamide
    other Names
    1. cytoxan
    type
    DRUG
  4. arm Group Labels
    1. treatment arm
    description
    40 mg/d PO days 1-4, 9-12, 17-20
    name
    dexamethasone
    other Names
    1. decadron
    type
    DRUG
  5. arm Group Labels
    1. treatment arm
    description
    1. st trans: 140 mg/m2 IV over 20 mins day -1 2. nd trans: 200mg/m2 IV over 20 mins day -1
    name
    melphalan
    type
    DRUG
  6. arm Group Labels
    1. treatment arm
    description
    maint: 50 mg/d PO every other day until progression
    name
    prednisone
    other Names
    1. steroid
    type
    DRUG
  7. arm Group Labels
    1. treatment arm
    description
    ind: 50 mg increased by 50 mg every week to max 400 mg PO qhs for 35 days maint: 50 mg/d increased by 50 mg every week to 200 mg PO daily until progression
    name
    thalidomide
    other Names
    1. thalomid
    type
    DRUG
  8. arm Group Labels
    1. treatment arm
    description
    2-4 x 10\^6/kg IV day 0
    name
    peripheral blood stem cell transplantation
    other Names
    1. stem cell transplant
    type
    PROCEDURE
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
147
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Overall Survival
    time Frame
    4-7 years
secondary Outcomes
  1. description
    To assess Grade 3-5 AE related to thalidomide/dexamethasone when administered as a pre-transplant induction regimen.
    measure
    Assess Toxicity of Thalidomide/Dexamethasone as a Pre-transplant Induction Regimen.
    time Frame
    Induction
Full study description
brief Summary
RATIONALE: Thalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Giving thalidomide before and after peripheral stem cell transplant may be effective in treating newly diagnosed multiple myeloma. PURPOSE: This phase II trial is studying how well giving thalidomide with chemotherapy and peripheral stem cell transplant work in treating patients with newly diagnosed multiple myeloma.
detailed Description
OBJECTIVES: * Determine the efficacy and toxicity of thalidomide and dexamethasone as a pre-transplantation induction regimen in patients with multiple myeloma. * Determine, preliminarily, the safety and efficacy of prednisone and thalidomide maintenance therapy in these patients. * Correlate chromosome 13 abnormalities with therapeutic response in patients treated with this regimen. * Correlate specific subsets of chromosome aberrations with event-free and overall survival of patients treated with this regimen. * Evaluate immune reconstitution and recovery after first and second transplantation in these patients. OUTLINE: This is a multicenter study. * Induction chemotherapy: Patients receive oral thalidomide once daily on days 1-35 and oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Treatment repeats every 35 days for 3 courses in the absence of disease progression or unacceptable toxicity. * Stem cell mobilization and collection: Beginning 5-7 days, but no more than 3 weeks, after completion of induction chemotherapy, patients receive cyclophosphamide IV over 45-60 minutes on day 0, filgrastim (G-CSF) subcutaneously (SC) on days 1-10, and sargramostim (GM-CSF) SC beginning on day 1 and continuing until completion of peripheral blood stem cell (PBSC) collection. Patients begin PBSC collection on day 11 or as soon as blood counts recover. * First transplantation: Within 3-6 weeks after cyclophosphamide administration, patients receive melphalan IV over 20 minutes on day -1. Patients undergo PBSC infusion on day 0. Patients receive GM-CSF SC or IV beginning on day 6 and continuing until blood counts recover. * Second transplantation: Between 2-4 months after first transplantation, patients undergo a second tandem melphalan and PBSC transplantation with GM-CSF support as above. * Maintenance therapy: Beginning 70-90 days post-transplantation, patients receive oral prednisone every other day and oral thalidomide once daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 12 months for 10 years. PROJECTED ACCRUAL: Approximately 99 patients will be accrued for this study within 18 months.
Source references
references
  1. citation
    Hussein MA, Bolejack V, Zonder JA, Durie BG, Jakubowiak AJ, Crowley JJ, Barlogie B. Phase II study of thalidomide plus dexamethasone induction followed by tandem melphalan-based autotransplantation and thalidomide-plus-prednisone maintenance for untreated multiple myeloma: a southwest oncology group trial (S0204). J Clin Oncol. 2009 Jul 20;27(21):3510-7. doi: 10.1200/JCO.2008.19.9240. Epub 2009 Jun 22.
    pmid
    19546405
    type
    RESULT
  2. citation
    Hussein MA, Jakubowiak AJ, Bolejack V, et al.: S0204: melphalan (MEL)-based tandem autotransplants (TAT) for multiple myeloma (MM) with thalidomide/dexamethasone (TD) induction and thalidomide/prednisone (TP) maintenance: a phase II trial of the Southwest Oncology Group. [Abstract] Blood 108 (11): A-3088, 2006.
    type
    RESULT
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-9d30c67febb37cb67da8
      requested nct id
      NCT00040937
      primary nct id
      NCT00040937
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      c21effc5e7c7d6b692522bcd6f736738f78fcbf57ff02ab6810f107811f68a88
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-9d30c67febb37cb67da8
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00040937
      occurrences
      1. context exact
        NCT00040937
        end
        11
        exact text
        NCT00040937
        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/309/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      69215f0f6f399778318eef3dcd615716858ec8404b23443512c6f05c214bc092

    Preserved source evidence · Not medical advice