Skip to content
Triangle logo TriangleGet started
← Study library

NCT00523848 · REGISTRY CONDITION SEARCH

Bortezomib, Doxorubicin Hydrochloride Liposome, and Thalidomide as First-line Therapy in Treating Patients With Previously Untreated Stage I, II, or 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
2017-02-23

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Giving bortezomib together with doxorubicin hydrochloride liposome and thalidomide may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bortezomib together with doxorubicin hydrochloride liposome and thalidomide works as first-line therapy in treating patients with previously untreated 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

Overall Response Rate (Complete and Partial)

→

outcome · POSTED

Complete Response Rate

→

outcome · POSTED

Time to Disease Progression

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: * Diagnosis of stage I, II, or III multiple myeloma requiring therapy * No prior systemic therapy for multiple myeloma * Patients who have received steroids or radiotherapy for cord compression or spinal cord disease are eligible for this study * Patients who have received 1 prior course of antimyeloma therapy may be enrolled at the investigator's discretion provided disease progression is not noted PATIENT CHARACTERISTICS: Inclusion criteria: * Karnofsky performance status 60-100% * Platelet count ≥ 75,000 cells/mm\^3 (\< 75,000 cells/mm\^3 secondary to extensive bone marrow disease allowed at the PI's discretion with appropriate transfusion support) * ANC ≥ 1,000 cells/mm\^3 * Hemoglobin ≥ 8.0 g/dL (\< 8 g/dL secondary to extensive bone marrow disease allowed at the PI's discretion with appropriate transfusion support) * Creatinine clearance \> 20 mL/min * AST and ALT ≤ 2 times upper limit of normal (ULN) OR ≤ 3 times ULN (in the presence of liver metastases) * Alkaline phosphatase ≤ 2 times ULN OR ≤ 3 times ULN (in the presence of liver metastases) * Total bilirubin ≤ 2 times ULN OR ≤ 3 times ULN (in the presence of liver metastases) * Ejection fraction ≥ 50% by MUGA or 2-D echocardiogram * Negative pregnancy test * Fertile patients must use at least 1 highly effective and 1 additional effective contraception method 4 weeks prior to, during, and 3 months after completion of study therapy * HIV-negative * Must have sufficient mental capacity to understand the explanation of the study and to provide informed consent * Willingness and ability to comply with the FDA-mandated S.T.E.P.S. program Exclusion criteria: * Pregnant or lactating * Active, serious infections uncontrolled by antibiotics * Any medical condition or reason that, in the investigator's opinion, makes the patient unsuitable to participate in this clinical trial * History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin hydrochloride or the components of doxorubicin hydrochloride liposome or bortezomib, boron, or mannitol * Any of the following conditions: * History of uncontrolled New York Heart Association class II-IV heart disease or clinical evidence of congestive heart failure * Myocardial infarction within the past 6 months * Uncontrolled angina * Severe uncontrolled ventricular arrhythmias, ECG evidence of acute ischemia, or active conduction system abnormalities * Peripheral neuropathy ≥ grade 2 PRIOR CONCURRENT THERAPY: * See Disease Characteristics
healthy Volunteers
false
maximum Age
120 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive low-dose oral thalidomide once a day on days 1-28, bortezomib IV on days 1, 4, 15, and 18, and doxorubicin hydrochloride liposome IV over 60-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity
    intervention Names
    1. Drug: bortezomib
    2. Drug: pegylated liposomal doxorubicin hydrochloride
    3. Drug: thalidomide
    label
    Arm 1
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm 1
    description
    IV
    name
    bortezomib
    type
    DRUG
  2. arm Group Labels
    1. Arm 1
    description
    IV
    name
    pegylated liposomal doxorubicin hydrochloride
    type
    DRUG
  3. arm Group Labels
    1. Arm 1
    description
    Oral
    name
    thalidomide
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
46
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Overall Response Rate (Complete and Partial)
    time Frame
    Every 3 months
secondary Outcomes
  1. measure
    Complete Response Rate
    time Frame
    Every 3 months
  2. measure
    Time to Disease Progression
    time Frame
    Every 3 monthsntil the date of first documented progression or date of death from any cause, whichever came first
Full study description
brief Summary
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Giving bortezomib together with doxorubicin hydrochloride liposome and thalidomide may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bortezomib together with doxorubicin hydrochloride liposome and thalidomide works as first-line therapy in treating patients with previously untreated multiple myeloma.
detailed Description
OBJECTIVES: Primary * To determine the overall response rate (complete response and partial response) in patients previously untreated stage I, II, or III multiple myeloma. Secondary * To evaluate the complete response rate in patients treated with this regimen. * To determine the time to disease progression from the start of this therapy in patients treated with this regimen. OUTLINE: Patients receive low-dose oral thalidomide once a day on days 1-28, bortezomib IV on days 1, 4, 15, and 18, and doxorubicin hydrochloride liposome IV over 60-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with residual disease who continue to show response after completion of 6 courses may receive 2 additional courses for a total of 8 courses. After completion of study treatment, patients are followed every 3 months.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-67a5f1fa4daf3ea708f9
      requested nct id
      NCT00523848
      primary nct id
      NCT00523848
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      8c0003b89c020d136ed2400dc671fc17f083bf2cbfc3a6d0bf357b9afb2afb8d
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-67a5f1fa4daf3ea708f9
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00523848
      occurrences
      1. context exact
        NCT00523848
        end
        11
        exact text
        NCT00523848
        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/749/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      2a98071edf651e295ab456e3ce03a4b3fac732fb0ed392c153106aec7f281ebf

    Preserved source evidence · Not medical advice