Skip to content
Triangle logo TriangleGet started
← Study library

NCT00792142 · REGISTRY CONDITION SEARCH

Bortezomib, Thalidomide, and Dexamethasone After Melphalan and Stem Cell Transplant in Treating Patients With Stage I-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
PHASE2
Status at capture
COMPLETED
Registry last update
2021-08-19

RATIONALE: Bortezomib and thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Bortezomib may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving bortezomib together with thalidomide and dexamethasone may kill any cancer cells that remain after high-dose melphalan and stem cell transplant in patients with multiple myeloma. PURPOSE: This phase II trial is studying the side effects of giving bortezomib together with thalidomide and dexamethasone after melphalan and stem cell transplant and to see how well it works in treating patients with stage I-III 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

Number of Participants With Adverse Events

→

outcome · POSTED

One Year Overall Survival

→

outcome · POSTED

Count of Response in Patients Started on Maintenance Therapy

→

outcome · POSTED

One Year Progression-free Survival (PFS)

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
Inclusion Criteria: * Multiple Myeloma patients with symptomatic disease, stage II or III at diagnosis or progressive stage I requiring chemotherapy and/or radiation therapy (by Salmon-Durie classification), who are not eligible for tandem transplant study using TMI; because of previous radiation or eligibility criteria; documentation of disease staging by both Salmon-Durie classification and International Staging System (ISS) is required * Patients with non-secretory myeloma should have measurable serum free-light chain protein by the Free-lite test or measurable disease such as a soft tissue myeloma * A minimum of 4 x 10\^6 of CD 34 Positive cell/kg has been harvested * A Karnofsky performance status (KPS) of \>= 70% is required unless the KPS is impaired due to bone disease * No contraindication to the collection of a minimum of 4 x 10\^6 CD34+ cells/kg by apheresis * All patients must have signed a voluntary, informed consent in accordance with institutional and federal guidelines * Bilirubin =\< 1.5 mg/dl * Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvate transaminase (SGPT) \< 2.5 x upper limits of normal * Creatinine clearance of \>= 40cc/min * Absolute neutrophil count of \> 1000/ul * Platelet count of \> 100,000/ul * Cardiac ejection fraction \>= 45% by multigated acquisition (MUGA) scan and/or by echocardiogram * Diffusing capacity of the lung for carbon monoxide (DLCO) \>= 50% of predicted lower limit * Human immunodeficiency virus (HIV) antibody tests negative * No other medical, or psychosocial problems which in the opinion of the primary physician or principal investigator would place the patient at unacceptably high risk from this treatment regimen Exclusion Criteria: * Presence of peripheral neuropathy \>= grade II * Patients with evidence of disease progression (with \>= 25% increase in M protein) on bortezomib and or thalidomide therapy prior to transplant * Pregnant or nursing women, as well as women of child bearing age, who are unwilling to use a dual method of contraception and men who are unwilling to use condom * Patients with history of hypersensitivity to bortezomib, boron or mannitol
healthy Volunteers
false
maximum Age
70 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive high-dose melphalan IV over 30 minutes on days -2 and -1 and undergo autologous peripheral blood stem cell transplantation on day 0. Patients receive filgrastim IV or SC beginning on day 5 and continuing until blood counts recover. Beginning 4 to 8 weeks after transplantation, patients receive maintenance therapy comprising bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral dexamethasone on days 1 to 4. Treatment with dexamethasone repeats every month for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of bortezomib, patients receive oral thalidomide once daily until disease progression.
    intervention Names
    1. Drug: bortezomib
    2. Drug: dexamethasone
    3. Drug: melphalan
    4. Drug: thalidomide
    5. Genetic: cytogenetic analysis
    6. Genetic: fluorescence in situ hybridization
    7. Other: laboratory biomarker analysis
    8. Other: questionnaire administration
    9. Procedure: autologous hematopoietic stem cell transplantation
    10. Procedure: peripheral blood stem cell transplantation
    label
    Treatment (stem cell transplant, maintenance treatment)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (stem cell transplant, maintenance treatment)
    description
    Given IV
    name
    bortezomib
    type
    DRUG
  2. arm Group Labels
    1. Treatment (stem cell transplant, maintenance treatment)
    description
    Given orally
    name
    dexamethasone
    type
    DRUG
  3. arm Group Labels
    1. Treatment (stem cell transplant, maintenance treatment)
    description
    Given IV
    name
    melphalan
    type
    DRUG
  4. arm Group Labels
    1. Treatment (stem cell transplant, maintenance treatment)
    description
    Given orally
    name
    thalidomide
    type
    DRUG
  5. arm Group Labels
    1. Treatment (stem cell transplant, maintenance treatment)
    description
    Performed on baseline and post transplant bone marrow specimens
    name
    cytogenetic analysis
    type
    GENETIC
  6. arm Group Labels
    1. Treatment (stem cell transplant, maintenance treatment)
    description
    Performed on baseline and post transplant bone marrow specimens
    name
    fluorescence in situ hybridization
    type
    GENETIC
  7. arm Group Labels
    1. Treatment (stem cell transplant, maintenance treatment)
    description
    Baseline, post transplant and prior to start of bortezomib, every 3 months post transplant for the first year, after 6 cycles of bortezomib, every year after transplant for 2-4 years.
    name
    laboratory biomarker analysis
    type
    OTHER
  8. arm Group Labels
    1. Treatment (stem cell transplant, maintenance treatment)
    description
    Completed at baseline (within 6 weeks prior to enrollment) and at 2 months post transplant and once a month after that for the first year. For the second year the questionnaire will be completed every 3 months as long as on thalidomide for the duration of the study.
    name
    questionnaire administration
    type
    OTHER
  9. arm Group Labels
    1. Treatment (stem cell transplant, maintenance treatment)
    description
    Minimum dose of 2 X 10(6) CD34 + cells/kg day 0 after two days of treatment with Melphalan
    name
    autologous hematopoietic stem cell transplantation
    type
    PROCEDURE
  10. arm Group Labels
    1. Treatment (stem cell transplant, maintenance treatment)
    description
    Minimum dose of 2 X 10(6) CD34 + cells/kg day 0 after two days of treatment with Melphalan
    name
    peripheral blood stem cell transplantation
    type
    PROCEDURE
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
45
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    All grade 3 and above treatment-related adverse events (AEs) during bortezomib/dexamethasone treatment cycles.
    measure
    Number of Participants With Adverse Events
    time Frame
    After 4 months of maintenance therapy
  2. description
    One year overall survival estimated using the product-limit method of Kaplan and Meier. Defined as the percentage of patients alive at year one after starting treatment.
    measure
    One Year Overall Survival
    time Frame
    From date of treatment initiation until death from any cause, assessed up to one year.
secondary Outcomes
  1. description
    Complete Response (CR): Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. Very Good Partial Response (VGPR): Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \< 100mg per 24-h. Partial Response (PR): \> 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by \> 90% or to \< 200mg per 24-h In addition to the above listed criteria, if present at baseline, a . 50% reduction in the size of soft tissue plasmacytomas is also required. Stable Disease (SD): Not meeting criteria for CR, VGPR, PR or progressive disease. Relapse: Any of the following: Reappearance of serum or urine M-protein by immunofixation or electrophoresis Development of \> 5% plasma cells in the bone marrow. Appearance of any other sign of progression (i.e., new plasmacytoma, lytic bone lesion)
    measure
    Count of Response in Patients Started on Maintenance Therapy
    time Frame
    Post-Thalidomide at 1 year.
  2. description
    PFS estimated using the product-limit method of Kaplan and Meier. Defined as the percentage of patients progression-free at year one after starting treatment. International Myeloma Working Group uniform response criteria for disease progression: Increase of \> 25% from baseline in Serum M-component and/or (the absolute increase must be \> 0.5 g/dl); Urine M-component and/or (the absolute increase must be \> 200 mg/24 h; Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels. The absolute increase must be \>l0mg/dl. Bone marrow plasma cell percentage: the absolute % must be \> 10%C; Definite development of new bone lesions or soft tissue plasmacytomas. or definite increase in the size of existing bone lesions or soft tissue plasmacytomas Development of hypercalcemia (corrected serum calcium \>11.5 mg/dl or 2.65 mmol/l) that can be attributed solely to the plasma cell proliferative disorder.
    measure
    One Year Progression-free Survival (PFS)
    time Frame
    From start of treatment initiation until disease progression, relapse or death from any cause, assessed up to 1 year.
Full study description
brief Summary
RATIONALE: Bortezomib and thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Bortezomib may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving bortezomib together with thalidomide and dexamethasone may kill any cancer cells that remain after high-dose melphalan and stem cell transplant in patients with multiple myeloma. PURPOSE: This phase II trial is studying the side effects of giving bortezomib together with thalidomide and dexamethasone after melphalan and stem cell transplant and to see how well it works in treating patients with stage I-III multiple myeloma.
detailed Description
OBJECTIVES: Primary * To assess the feasibility and toxicities of maintenance therapy with sequential bortezomib, thalidomide, and dexamethasone after high-dose melphalan and autologous peripheral blood stem cell transplantation in patients with multiple myeloma. * To assess whether administration of sequential bortezomib, thalidomide, and dexamethasone can improve progression-free survival of these patients. Secondary * To assess whether administration of sequential bortezomib, thalidomide, and dexamethasone can increase complete remission rate and duration of response in these patients. * To assess the impact of maintenance therapy with sequential bortezomib, thalidomide, and dexamethasone after transplantation on overall survival of these patients. * To evaluate the influence of cytogenetic abnormalities (e.g., chromosome 13 deletion, 14 q32 abnormality, t \[4;14\], chromosome 1 q21 amplification, and chromosome 17 deletion) on outcome by performing conventional cytogenetic study and fluorescence in situ hybridization (FISH) studies on baseline and post-transplant bone marrow specimens. OUTLINE: * High-dose melphalan and autologous peripheral blood stem cell transplantation (PBSCT): Patients receive high-dose melphalan IV over 30 minutes on days -2 and -1 and undergo autologous PBSCT on day 0. Patients receive filgrastim (G-CSF) IV or subcutaneously beginning on day 5 and continuing until blood counts recover. * Maintenance therapy: Beginning 4-8 weeks after transplantation, patients receive bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral dexamethasone on days 1-4; treatment with dexamethasone repeats every month for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of bortezomib, patients receive oral thalidomide once daily until disease progression. Patients complete the FACT-GOG neurotoxicity questionnaire periodically. Bone marrow samples are collected at baseline and post-transplant for cytogenetic analysis by FISH.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-28cfe9b7495bf30b80db
      requested nct id
      NCT00792142
      primary nct id
      NCT00792142
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      7ce45ebc7a47e1e4cde6baa29f832e27eaf5fea1fa56780ea4345505a9c0c346
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-28cfe9b7495bf30b80db
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00792142
      occurrences
      1. context exact
        NCT00792142
        end
        11
        exact text
        NCT00792142
        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/769/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      ecbfe5f439b3d4d284d4bd74d762b494e9111fb6d3e77849dcab6dcc7eae2200

    Preserved source evidence · Not medical advice