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NCT01078441 · REGISTRY CONDITION SEARCH

Bortezomib, Liposomal Doxorubicin Hydrochloride, Dexamethasone, and Cyclophosphamide in Treating Patients With Multiple Myeloma That Relapsed After Autologous Stem Cell Transplant

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
2015-01-12

This phase II trial is studying how well giving bortezomib together with liposomal doxorubicin hydrochloride, dexamethasone, and cyclophosphamide works in treating patients with multiple myeloma that relapsed after autologous stem cell transplant. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as liposomal doxorubicin hydrochloride, dexamethasone, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with liposomal doxorubicin hydrochloride, dexamethasone, and cyclophosphamide may kill more cancer cells.

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

One-year Survival in Patients Treated With This Regimen.

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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: * Diagnosis of multiple myeloma that was symptomatic at the time of initial diagnosis * Must have met the following criteria at one point during the disease course: * Bone marrow plasmacytosis with ≥ 10% plasma cells or sheets of plasma cells or biopsy-proven plasmacytoma * Symptomatic disease at initial diagnosis that prompted the initiation of therapy as well as evidence of end-organ damage at the time of diagnosis, including at least 1 of the following: * Anemia * Hypercalcemia * Bone disease (lytic bone lesions or pathologic fracture) * Renal dysfunction * Disease relapsed \< 12 months after autologous stem cell transplantation (SCT) * Measurable disease, as defined by the presence of ≥ 1 of the following: * Serum M-spike ≥ 1 g/dL * Urine M-spike ≥ 200 mg/24 hours * Involved free light chain (FLC) ≥ 10 mg/dL (provided the serum FLC is abnormal) * Plasma cells ≥ 30% * ECOG performance status 0-2 * Negative pregnancy test * Fertile patients must use effective contraception * At least 14 days since prior palliative and/or localized radiotherapy * Left ventricular ejection fraction (LVEF) normal by Echocardiography (ECHO) or multiple-gated acquisition (MUGA) scan * Hemoglobin \> 8 g/dL * Platelet count ≥ 75,000/mm\^3 (without transfusion support) * Absolute neutrophil count (ANC) ≥ 1,000/mm\^3 (without use of growth factors) * Creatinine \< 2.5 mg/dL * Direct bilirubin ≤ 1.5 mg/dL * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times upper limit of normal * All tests below must be performed within 14 days prior to registration: * Serum free light chain assay * Kappa free light chain * Lambda free light chain * Prior malignancy allowed provided it was treated curatively and has not relapsed in 5 years * Patients with basal cell skin cancer, in situ cervical cancer, or prostate cancer not requiring therapy are eligible Exclusion Criteria: * Therapy for relapsed disease following SCT * Known allergy to bortezomib or anthracyclines * Prior allogeneic SCT * Peripheral neuropathy ≥ grade 2 according to the Cancer Therapy Evaluation Program (CTEP) active version of the NCI Common Terminology Criteria for Adverse Events (CTCAE) * Concurrent uncontrolled illness that would limit study compliance, including the following: * Uncontrolled hypertension * Symptomatic congestive heart failure * Unstable angina * Uncontrolled cardiac arrhythmia * Uncontrolled psychiatric illness or social situation * Active uncontrolled infection * Prior doxorubicin hydrochloride exposure \> 240 mg/m\^2 * Active, uncontrolled seizure disorder * Seizures within the past 6 months * Pregnant or nursing
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive bortezomib 1.3 mg/m2 subcutaneously on days 1, 8, and 15; liposomal doxorubicin 30 mg/m2 intravenously (IV) over 1 hour on day 4; oral dexamethasone 20mg on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide 750 mg/m2 IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: liposomal doxorubicin
    2. Drug: bortezomib
    3. Drug: dexamethasone
    4. Drug: cyclophosphamide
    label
    Treatment (combination chemotherapy)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (combination chemotherapy)
    description
    Given IV
    name
    liposomal doxorubicin
    other Names
    1. Doxil
    2. Doxorubicin HCl Liposomal
    3. Doxorubicin Hydrochloride Liposomal
    4. Doxorubicin Hydrochloride Liposome
    type
    DRUG
  2. arm Group Labels
    1. Treatment (combination chemotherapy)
    description
    Given subcutaneously.
    name
    bortezomib
    other Names
    1. Velcade
    2. PS-341
    3. MLN-341
    4. LDP-341
    type
    DRUG
  3. arm Group Labels
    1. Treatment (combination chemotherapy)
    description
    Given orally
    name
    dexamethasone
    other Names
    1. Decadron
    2. Hexadrol
    3. Dexameth
    4. Dexone
    5. DXM
    type
    DRUG
  4. arm Group Labels
    1. Treatment (combination chemotherapy)
    description
    Given IV
    name
    cyclophosphamide
    other Names
    1. CTX
    2. Cytoxan
    3. Neosar
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
2
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Proportion of patients who are still alive at 1 year after registration.
    measure
    One-year Survival in Patients Treated With This Regimen.
    time Frame
    Assessed at 1 year
Full study description
brief Summary
This phase II trial is studying how well giving bortezomib together with liposomal doxorubicin hydrochloride, dexamethasone, and cyclophosphamide works in treating patients with multiple myeloma that relapsed after autologous stem cell transplant. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as liposomal doxorubicin hydrochloride, dexamethasone, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with liposomal doxorubicin hydrochloride, dexamethasone, and cyclophosphamide may kill more cancer cells.
detailed Description
PRIMARY OBJECTIVES: I. To evaluate the 1-year survival of patients with relapsed multiple myeloma treated with bortezomib, liposomal doxorubicin, dexamethasone, and cyclophosphamide. SECONDARY OBJECTIVES: I. To evaluate response rates in patients treated with this regimen. II. To evaluate the median time to progression in patients treated with this regimen. III. To evaluate the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive bortezomib 1.3 mg/m2 subcutaneously on days 1, 8, and 15; liposomal doxorubicin 30 mg/m2 intravenously (IV) over 1 hour on day 4; oral dexamethasone 20mg on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide 750 mg/m2 IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Peripheral blood and bone marrow samples may be collected for future research. Patients complete the Functional Assessment of Cancer Therapy (FACT) neurotoxicity questionnaire periodically. After completion of study treatment, patients are followed up every 3 months for 3 years.
Source references
Source notices and limitations
    Discovery and provenance
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      occurrences
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        exact text
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        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
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    Preserved source evidence · Not medical advice