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NCT00148317 · REGISTRY CONDITION SEARCH

Phase II Study of Velcade, Decadron, and Doxil Followed by Cyclophosphamide in 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
2017-07-18

PRIMARY STUDY OBJECTIVES * To evaluate the efficacy of the combination of bortezomib, dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide as a therapy for two different subsets of multiple myeloma patients: 1. Patients post first line therapy 2. Patients with relapsed/refractory disease who are bortezomib-naïve * To evaluate the safety of the combination of bortezomib and dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide as therapy for patients with multiple myeloma. SECONDARY STUDY OBJECTIVES * To evaluate the role of the combination of bortezomib dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide on the ability to collect \> 10 x 106 CD34+ cells/kg in \< 7 collections (for both subsets of multiple myeloma patients). * To evaluate the survival of patients who receive the combination of bortezomib dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide (for both subsets of patients).

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

Efficacy of Drug Combination as Therapy for Myeloma (Overall Response Rate)

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outcome · POSTED

Yield of CD34+ Stem Cells

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outcome · POSTED

Progression Free Survival

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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: * Subject must voluntarily sign and understand written informed consent. * Confirmed diagnosis of multiple myeloma as specified by the SWOG criteria and is detailed in Appendix I. * Measurable disease as defined the following: 1. For patients post induction therapy, any measurable paraprotein in the serum or urine and/or any plasmacytoma present on physical exam or imaging. 2. For patients with relapsed/refractory disease, \> 0.5 g/dL serum monoclonal protein, \> 0.1 g/dL serum free light chains, \> 0.2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s). * Age \> or = than 18 years at the time of signing the informed consent form. * Karnofsky performance status\> or =70% (\>60% if due to bony involvement of myeloma). * Group A (post-induction therapy)- patients who have received only one prior treatment regimen (eg VAD, Thal/Dex, BLT-D, MP, BiRD, or DVd) with at least 20 patients having received a Revlimid based regimen or Group B(\>1st line of therapy)- patients with relapsed/refractory multiple myeloma who have received two or more prior treatment regimens . * If the patient is a woman of childbearing age, she must have a negative serum or urine pregnancy test within 7 days of starting study and must use effective contraception throughout the course of the study. * Life expectancy \> 12 weeks. * Absolute neutrophil count (ANC)\> or = 1500 cells/mm3 (\> or = 1000 for patients with bone marrow biopsy displaying \> 50% involvement by myeloma) * Platelets count \> or = 50,000/mm3 (\> or = 30,000 for patients with bone marrow biopsy displaying \> 50% involvement by myeloma) * Hemoglobin \> 9.0 g/dL * Serum SGOT/AST \<3.0 x upper limits of normal (ULN) * Serum SGPT/ALT \<3.0 x upper limits of normal (ULN) * Serum creatinine \< 2.5 mg/dL or creatinine clearance \> 40ml/min * Serum total bilirubin \< 1.5 x ULN * Patients must have a MUGA scan with LVEF \>50% Exclusion Criteria: * Patients with non-secretory MM (no measurable monoclonal protein, free light chains, and/or M-spike in blood or urine) unless measurable disease is available with imaging techniques such as MRI and PET scan. * Prior treatment with bortezomib. * Peripheral neuropathy of \> Grade 2 as defined by CTCAE Version 3.0 (see Appendix II) * History of allergic reactions to compounds containing mannitol, bortezomib, conventional formulation of doxorubicin HCL or the components of DOXIL. * Prior history of other malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless disease free for ³ 5 years. * NYHA Class III or IV heart disease. History of active unstable angina, congestive heart disease, serious uncontrolled cardiac arrhythmia or myocardial infarction within 6 months. * Female patients who are pregnant or breastfeeding. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. * Known HIV or hepatitis A, B, or C positivity * Active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program. * Any concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place him/her at unacceptable risk, including, but not limited to, uncontrolled hypertension, uncontrolled diabetes, active uncontrolled infection, and/or acute chronic liver disease (i.e., hepatitis, cirrhosis). * No prior anti-myeloma therapy within 2 weeks of treatment initiation.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Drug: Bortezomib
    2. Drug: dexamethasone
    3. Drug: liposomal doxorubicin
    4. Drug: cyclophoshamide
    5. Drug: filgrastim
    label
    Treatment Arm
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment Arm
    description
    During Induction Phase (6 cycles): Bortezomib 1.3 mg/m2 on days 1, 4, 8, and 11 During 21-day mobilization cycle (1 cycle): Bortezomib 1.3 mg/m2 on days 1, 4, 8, and 11
    name
    Bortezomib
    other Names
    1. velcade
    type
    DRUG
  2. arm Group Labels
    1. Treatment Arm
    description
    During Induction Phase (6 cycles): dexamethasone 40 mg on days 1-4, 8-11, and 15-18
    name
    dexamethasone
    other Names
    1. decadron
    type
    DRUG
  3. arm Group Labels
    1. Treatment Arm
    description
    If patients achieve less then a PR during the induction phase after 2 cycles, or less then a CR after 4 cycles: Liposomal doxorubicin was added at 30 mg/m2 on day 4 for the remaining cycles
    name
    liposomal doxorubicin
    type
    DRUG
  4. arm Group Labels
    1. Treatment Arm
    description
    During the 21 day mobilization phase (1 cycle): cyclophosphamide at 3 g/m2 on day 8
    name
    cyclophoshamide
    other Names
    1. cytoxan
    type
    DRUG
  5. arm Group Labels
    1. Treatment Arm
    description
    During the 21 day mobilization phase (1 cycle): 10 μg/kg/day for 10 consecutive days starting 24 hours after cyclophosphamide administration on day 9
    name
    filgrastim
    other Names
    1. neupogen
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
intervention Model Description
Consolidation: All patients will receive 2 cycles of bortezomib (VEL) and dexamethasone (DEX). Patients who achieve a complete response after 2 cycles will receive 4 additional cycles of VEL/DEX before mobilization. Patients who do not achieve at least a partial response after 2 cycles will receive 4 more cycles of VEL/DEX plus DOXIL. Patients who achieve a partial response after 2 cycles on VEL/DEX, will continue this combination for 2 more cycles. Patients who achieve a complete response after 4 cycles will receive 2 additional cycles of VEL/DEX before mobilization. Patients who remain with a partial response after 4 cycles of VEL/DEX will receive 2 additional cycles of the combination of VEL/DEX plus DOXIL. Mobilization: Patients who complete 6 cycles of consolidation will proceed to mobilization. Patients will receive one cycle of VEL plus high dose CYTOXAN followed by G-CSF beginning 24 hours after CYTOXAN given for a total of 10 daily doses.
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
38
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Myeloma response criteria developed by Bladé et al. was used to categorize response.
    measure
    Efficacy of Drug Combination as Therapy for Myeloma (Overall Response Rate)
    time Frame
    Best response at any point during each respective study phase was collected - once after consolidation/prior to mobilization (approximately 6 cycles after start of treatment), and once after mobilization
secondary Outcomes
  1. description
    This is the yield of CD34+ stem cells collection after high dose cyclophosphamide.
    measure
    Yield of CD34+ Stem Cells
    time Frame
    Occurred after mobilization, and prior to Stem cell transplant; a 7 day limit was imposed on stem cell collection
  2. description
    Response was assessed using IMWG guidelines, which for progressive disease are as follows: Increase of \> 25% from lowest response value in any one or more of the following: * 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 \> 10 mg/dL * Bone marrow plasma cell percentage; the absolute percentage must be \> 10% * 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 hypercalcaemia (corrected serum calcium \> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder IF starting M protein component is \> 5g/dL, then absolute increase of 1g is sufficient for progression.
    measure
    Progression Free Survival
    time Frame
    Date of progression, assessed from start of trial to Final data cut off date (15 April 2011)
Full study description
brief Summary
PRIMARY STUDY OBJECTIVES * To evaluate the efficacy of the combination of bortezomib, dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide as a therapy for two different subsets of multiple myeloma patients: 1. Patients post first line therapy 2. Patients with relapsed/refractory disease who are bortezomib-naïve * To evaluate the safety of the combination of bortezomib and dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide as therapy for patients with multiple myeloma. SECONDARY STUDY OBJECTIVES * To evaluate the role of the combination of bortezomib dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide on the ability to collect \> 10 x 106 CD34+ cells/kg in \< 7 collections (for both subsets of multiple myeloma patients). * To evaluate the survival of patients who receive the combination of bortezomib dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide (for both subsets of patients).
Source references
Source notices and limitations
    Discovery and provenance
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        exact text
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      query cond
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      query disease state id
      ds-plasma-cell-neoplasms
      source file
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    Preserved source evidence · Not medical advice