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NCT00366106 · REGISTRY CONDITION SEARCH

Alternative Schedule of Velcade/Dexamethasone Plus Doxil for 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
TERMINATED
Registry last update
2012-04-06

The current study is being conducted to evaluate the possibility that a different schedule of bortezomib, doxorubicin HCl liposome, and dexamethasone might decrease the incidence of peripheral neuropathy yet maintain similar efficacy and allow maintenance of bortezomib dosing for a longer period.

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

Incidence of Treatment-emergent Peripheral Neuropathy

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outcome · POSTED

Time to Progression (TTP)

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outcome · POSTED

Number of Participants With Treatment Response

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outcome · POSTED

Relative Dose Intensity of Bortezomib

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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: * Patient is at least 18 years of age. * Patient has confirmed diagnosis of relapsed/refractory multiple myeloma with measurable disease by serum or urine. Measurable disease defined as monoclonal protein of ≥ 1g/dl on serum protein electrophoresis (SPEP) or \> 200 mg urine M protein/ 24 hours * Patient has received at least 1 prior treatment regimen. (Prior treatment with bortezomib is allowed.) * Patient has ECOG ≤ 2 * Patient provides voluntary written informed consent before performance of any study-relates procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. * Patients who have received prior high dose chemotherapy with stem cell support are eligible for this study. * Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. * Male subject agrees to use an acceptable method for contraception for the duration of the study. Exclusion Criteria: * Patient has a platelet count of \< 50, 000 cells/mm³, within 14 days before enrollment. * Patient has an absolute neutrophil count (ANC) ≤ 750/mm³ within 14 days before enrollment. * Patient has a calculated or measured creatinine clearance of \< 20 mL/min within 14 days before enrollment and/or serum creatinine ≥ 2.5 mg/dl. * Patient has hemoglobin \< 7.5 g/dl. * Patient has ≥ Grade 2 peripheral neuropathy within 14 days before enrollment. * Myocardial infarction within 6 months prior to enrollment or has (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any electrocardiogram (ECG) abnormality at screening has to be documented by the investigator as not medically relevant. * Patient has received a total cumulative dosage of anthracyclines exceeding 550 mg/m2. * Patient has hypersensitivity to boron or mannitol. * Patient has history of hypersensitivity reactions to a conventional formulation of doxorubicin HCl or the components of DOXIL. * Patient has clinically significant coexisting illness unrelated to myeloma. * Patient has uncontrolled diabetes. * Patient has plasma cell leukemia. * Patient has serum bilirubin \> 1.5 x upper normal limit, alanine aminotransaminase (ALT), aspartate aminotransferase (AST) \> 2.5 x upper normal limit (ULN), or alkaline phosphatase \> 2.5 x ULN. * Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (B-hCG)pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women. * Patient has received other investigational drugs within 14 days before enrollment. * Patient has serious medical or psychiatric illness likely to interfere with participation in this clinical study.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
interventions
  1. description
    Patients will be treated with bortezomib at 1.3mg/m\^2 on Days 1, 4, 15, and 18 every 28 days (cycle).
    name
    bortezomib
    other Names
    1. Velcade
    type
    DRUG
  2. description
    Dexamethasone tablets will be given at 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days (cycle).
    name
    dexamethasone
    other Names
    1. Decadron
    type
    DRUG
  3. description
    Patients will receive intravenous doxorubicin HCl liposome injection given at 30 mg/m\^2 on Day 4 every 28 days (cycle).
    name
    doxorubicin HCl liposome
    other Names
    1. Doxil
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
32
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Incidence of Treatment-emergent Peripheral Neuropathy
    time Frame
    Every 4 weeks from start of treatment until end of treatment
secondary Outcomes
  1. measure
    Time to Progression (TTP)
    time Frame
    TTP was measured from day 1 of treatment until time of progression, assessed up to 40 months
  2. description
    Complete Response (CR), Partial Response (PR), and Minor Response (MR) each required stable bone disease and normal calcium levels. CR also required 100% serum protein electrophoresis (SPEP) reduction, negative immunofixation (IF), 100% urine protein electrophoresis (UPEP)reduction, and \<5% plasma cells in bone marrow. PR also required \>=50% SPEP reduction, \>=90% UPEP reduction, and \>=50% reduction in plasma cells in bone marrow. MR also required \>=25% SPEP reduction, \>=50% UPEP reduction, and \> 25% reduction in plasma cells.
    measure
    Number of Participants With Treatment Response
    time Frame
    Every 8 weeks from start of treatment until end of treatment
  3. description
    Relative dose intensity is defined as actual dose/scheduled dose. Bortezomib is administered on Days 1, 4, 15, and 18 every 28 days.
    measure
    Relative Dose Intensity of Bortezomib
    time Frame
    Each dose of bortezomib (days 1, 4, 15, and 18 every 28 days)
Full study description
brief Summary
The current study is being conducted to evaluate the possibility that a different schedule of bortezomib, doxorubicin HCl liposome, and dexamethasone might decrease the incidence of peripheral neuropathy yet maintain similar efficacy and allow maintenance of bortezomib dosing for a longer period.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-5be8668431df773e8857
      requested nct id
      NCT00366106
      primary nct id
      NCT00366106
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      bb069792d2d77af3005e2a781762de1db7202cc4e9ae4d95b66ceb81c71ac37d
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-5be8668431df773e8857
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00366106
      occurrences
      1. context exact
        NCT00366106
        end
        11
        exact text
        NCT00366106
        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/806/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      6783555ed8883ee93bfff4006c0284726628d2fb02bab2d9c8962b9add4fa4d2

    Preserved source evidence · Not medical advice