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NCT01539083 · REGISTRY CONDITION SEARCH

Velcade (Bortezomib) Consolidation After Transplant

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2025-02-04

The purpose of this study is to determine if bortezomib when added to consolidation treatment with thalidomide and prednisolone leads to an improved response in patients with multiple myeloma who have undergone autologous stem cell transplant and initial treatment with bortezomib, cyclophosphamide, and dexamethasone.

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

Consolidation Phase: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR) at Month 12

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outcome · POSTED

Consolidation Phase: Percentage of Participants With Complete Response (CR) at Months 3, 6, 9 and 12

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outcome · POSTED

Consolidation Phase: Percentage of Participants With Stringent Complete Response (sCR) at Months 3, 6, 9 and 12

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outcome · POSTED

Progression Free Survival (PFS)

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outcome · POSTED

Disease-free Survival (DFS)

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

Consolidation Phase: Change From Baseline in AQOL-6D Scores at the End of the Consolidation Phase

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outcome · POSTED

Consolidation Phase: Change From Baseline in FACT/GOG-NTX Total Score at the End of the Consolidation Phase

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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: * Previously diagnosed with multiple myeloma based on international myeloma working group (IMWG) criteria.and meet all of the following; Serum M-protein greater than or equal to (\>=) 1 gram per deciliter (g/dL) (\>=10 gram per liter); Urine M-protein \>=200 milligram (mg) per 24 hour and Serum Free Light chain (FLC) assay: Involved FLC Level \>=10 mg/dL (\>=100 mg/L) provided serum FLC ratio is normal * Meet the pretreatment laboratory criteria as specified in the study protocol at and within 21 days before baseline (Day 1 of Cycle 1, before bortezomib administration for induction). * Have ECOG status 0-2. * Men and women must practice an appropriate method of birth control as specified in the study protocol from signing of the informed consent form though to the 12-month visit/early termination visit. Exclusion criteria: * Has previously received treatment for multiple myeloma (including prior therapy with radiation or pulsed dexamethasone) as specified in the study protocol. * Has a history of any other malignancy within 5 years before enrolment as specified in the study protocol. * Has had major surgery as specified in the study protocol within 30 days before enrolment. * Had a myocardial infarction within 6 months of enrolment or has New York Heart Association (NYHA) Class III or IV heart failure (or other clinically significant cardiac medical history as specified in the study protocol). * Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Bortezomib (Velcade) 1.3 milligram per square meter (mg/m\^2) subcutaneously (SC) on Days 1, 4, 8, and 11; cyclophosphamide 300 mg/m\^2 orally on Days 1, 8, and 15; and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 in three 21-day treatment cycles. Participants who completed induction phase entered into the consolidation treatment phase.
    intervention Names
    1. Drug: Bortezomib
    2. Drug: Cyclophosphamide
    3. Drug: Dexamethasone
    label
    Bortezomib + Cyclophosphamide + Dexamethasone [VCD Induction]
    type
    EXPERIMENTAL
  2. description
    Thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
    intervention Names
    1. Drug: Thalidomide
    2. Drug: Prednisolone
    label
    Thalidomide + Prednisolone [TP Consolidation]
    type
    EXPERIMENTAL
  3. description
    Bortezomib 1.3 mg/m\^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
    intervention Names
    1. Drug: Thalidomide
    2. Drug: Bortezomib
    3. Drug: Prednisolone
    label
    Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]
    2. Thalidomide + Prednisolone [TP Consolidation]
    description
    Thalidomide 100 mg tablet, orally.
    name
    Thalidomide
    type
    DRUG
  2. arm Group Labels
    1. Bortezomib + Cyclophosphamide + Dexamethasone [VCD Induction]
    2. Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]
    description
    Bortezomib 1.3 milligram per square meter (mg/m\^2) solution for injection subcutaneously (SC).
    name
    Bortezomib
    type
    DRUG
  3. arm Group Labels
    1. Bortezomib + Cyclophosphamide + Dexamethasone [VCD Induction]
    description
    Cyclophosphamide 300 mg/m\^2 orally.
    name
    Cyclophosphamide
    type
    DRUG
  4. arm Group Labels
    1. Bortezomib + Cyclophosphamide + Dexamethasone [VCD Induction]
    description
    Dexamethasone 20 mg orally.
    name
    Dexamethasone
    type
    DRUG
  5. arm Group Labels
    1. Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]
    2. Thalidomide + Prednisolone [TP Consolidation]
    description
    Prednisolone 50 mg orally.
    name
    Prednisolone
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
256
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    CR as per IMWG criteria is defined as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and less than (\<) 5 percent plasma cells in bone marrow. VGPR as per IMWG criteria is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90 percent or greater reduction in serum M-protein plus urine M-protein level \<100 milligram (mg) per 24 hours.
    measure
    Consolidation Phase: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR) at Month 12
    time Frame
    Month 12
secondary Outcomes
  1. description
    CR as per IMWG criteria is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and \<5 percent plasma cells in bone marrow.
    measure
    Consolidation Phase: Percentage of Participants With Complete Response (CR) at Months 3, 6, 9 and 12
    time Frame
    Months 3, 6, 9 and 12
  2. description
    sCR as per IMWG criteria is CR plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow. CR is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and \<5 percent plasma cells in bone marrow.
    measure
    Consolidation Phase: Percentage of Participants With Stringent Complete Response (sCR) at Months 3, 6, 9 and 12
    time Frame
    Months 3, 6, 9 and 12
  3. description
    PFS, calculated as the time between randomization to disease progression or death (regardless of cause), whichever occurred first. Progressive disease as per IMWG criteria: increase of \>= 25 percent from lowest response level in Serum M-component and/or (the absolute increase must be \>=0.5 gram per deciliter \[g/dL\]) Urine M-component and/or (the absolute increase must be \>=200 mg/24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase must be \>10 mg/dL. Bone marrow plasma cell percentage: the absolute percent must be \>=10 percent. 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 millimole per liter (mmol/L) that can be attributed solely to the plasma cell proliferative disorder.
    measure
    Progression Free Survival (PFS)
    time Frame
    Baseline until progressive disease (up to 5 years)
  4. description
    DFS, defined as the duration from the start of CR to the time of relapse from CR. DFS applied only to participants in CR. CR as per IMWG criteria is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and \<5 percent plasma cells in bone marrow. Relapse from CR: reappearance of serum or urine M-protein by immunofixation or electrophoresis; development of \>= 5 percent plasma cells in the bone marrow; appearance of any other sign of progression (ie, new plasmacytoma, lytic bone lesion, or hypercalcaemia).
    measure
    Disease-free Survival (DFS)
    time Frame
    Up to 5 years
  5. description
    OS was defined as the time between randomization and death. Death of a participant regardless of the cause was considered as an event.
    measure
    Overall Survival (OS)
    time Frame
    Up to 5 years
  6. description
    The assessment of quality of life-6D (AQoL-6D) is a multi-attribute health-related quality of life instrument (QoL). It comprises dimension scores for independent living, relationships, mental health, coping, pain, senses, and utility score for AQol-6D. Each scale ranges between 1 (best QoL) and -0.04 (worst possible QoL).
    measure
    Consolidation Phase: Change From Baseline in AQOL-6D Scores at the End of the Consolidation Phase
    time Frame
    Baseline, Month 12
  7. description
    Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) consists of 10 items and evaluates symptoms and concerns associated specifically with chemotherapy-induced neuropathy. 1 FACT/GOG-NTX total score has a range of 0 to 108 with a higher score indicating better quality of life.
    measure
    Consolidation Phase: Change From Baseline in FACT/GOG-NTX Total Score at the End of the Consolidation Phase
    time Frame
    Baseline, Month 12
Full study description
brief Summary
The purpose of this study is to determine if bortezomib when added to consolidation treatment with thalidomide and prednisolone leads to an improved response in patients with multiple myeloma who have undergone autologous stem cell transplant and initial treatment with bortezomib, cyclophosphamide, and dexamethasone.
detailed Description
This is an open-label (patients will know the identity of study treatments), randomized (patients will be assigned by chance to different treatments) study of bortezomib administered as consolidation therapy (therapy given once a remission is achieved) with thalidomide and prednisolone versus thalidomide and prednisolone alone in previously untreated patients with multiple myeloma. Multiple myeloma is a cancer of your plasma cells, a type of white blood cell present in your bone marrow. Patients in this study will receive initial therapy with bortezomib, cyclophosphamide, and dexamethasone (referred to as VCD induction therapy) and will undergo autologous stem cell transplant (ASCT) (a procedure where patients receive an infusion of immature blood cells \[stem cells\] from their own body to replenish the body's supply of healthy blood-forming cells) before randomization to one of two treatments: Treatment A (thalidomide for up to 12 months or until disease progression and prednisolone on alternate days continued indefinitely or until disease progression) or Treatment B (bortezomib for 32 weeks in addition to thalidomide up to 12 months or until disease progression and prednisolone on alternate days, continued indefinitely or until disease progression. Throughout the study, the patient's response to therapy will be assessed according to protocol-defined efficacy evaluations and by implementing defined disease response criteria (International Myeloma Working Group \[IMWG\] criteria). Safety will be evaluated throughout the study. Follow up for progression-free survival (PFS) and overall survival (OS) will be conducted from time of randomization to 3 years post-randomization. Two interim analyses are planned. The final analysis will be conducted after all patients have completed 12-month consolidation treatment phase or discontinued. The primary endpoint of number and percent of patients with complete response and very good partial response defined by IMWG criteria for multiple myeloma will be examined in the interim and final analyses after approximately 12 months of consolidation therapy. At the completion of the study, updated analyses of PFS and OS will be performed.
Source references
references
  1. citation
    Horvath N, Spencer A, Kenealy M, Joshua D, Campbell PJ, Lee JJ, Hou J, Qiu L, Kalff A, Khong T, Londhe A, Siggins S, van Kooten Losio M, Eisbacher M, Prince HM. Phase 3 study of subcutaneous bortezomib, thalidomide, and prednisolone consolidation after subcutaneous bortezomib-based induction and autologous stem cell transplantation in patients with previously untreated multiple myeloma: the VCAT study. Leuk Lymphoma. 2019 Sep;60(9):2122-2133. doi: 10.1080/10428194.2019.1579322. Epub 2019 Feb 19.
    pmid
    30777794
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      query disease state id
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      source file
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    Preserved source evidence · Not medical advice