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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01539083




Registration number
NCT01539083
Ethics application status
Date submitted
23/11/2011
Date registered
27/02/2012
Date last updated
27/12/2018

Titles & IDs
Public title
Velcade (Bortezomib) Consolidation After Transplant
Scientific title
An Open-label, Randomised Trial of Bortezomib Consolidation (With Thalidomide and Prednisolone) Vs Thalidomide and Prednisolone Alone in Previously Untreated Subjects With Multiple Myeloma After Receiving Bortezomib, Cyclophosphamide, Dexamethasone (VCD) Induction and Autologous Stem Cell Transplant
Secondary ID [1] 0 0
26866138-MMY-2073
Secondary ID [2] 0 0
CR018751
Universal Trial Number (UTN)
Trial acronym
VCAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Thalidomide
Treatment: Drugs - Bortezomib
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Prednisolone

Experimental: Bortezomib + Cyclophosphamide + Dexamethasone [VCD Induction] - 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.

Experimental: Thalidomide + Prednisolone [TP Consolidation] - 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.

Experimental: Bortezomib + Thalidomide + Prednisolone [VTP Consolidation] - 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.


Treatment: Drugs: Thalidomide
Thalidomide 100 mg tablet, orally.

Treatment: Drugs: Bortezomib
Bortezomib 1.3 milligram per square meter (mg/m^2) solution for injection subcutaneously (SC).

Treatment: Drugs: Cyclophosphamide
Cyclophosphamide 300 mg/m^2 orally.

Treatment: Drugs: Dexamethasone
Dexamethasone 20 mg orally.

Treatment: Drugs: Prednisolone
Prednisolone 50 mg orally.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Consolidation Phase: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR) at Month 12 - 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.
Timepoint [1] 0 0
Month 12
Secondary outcome [1] 0 0
Consolidation Phase: Percentage of Participants With Complete Response (CR) at Months 3, 6, 9 and 12 - 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.
Timepoint [1] 0 0
Months 3, 6, 9 and 12
Secondary outcome [2] 0 0
Consolidation Phase: Percentage of Participants With Stringent Complete Response (sCR) at Months 3, 6, 9 and 12 - 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.
Timepoint [2] 0 0
Months 3, 6, 9 and 12
Secondary outcome [3] 0 0
Progression Free Survival (PFS) - 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.
Timepoint [3] 0 0
Baseline until progressive disease (up to 5 years)
Secondary outcome [4] 0 0
Disease-free Survival (DFS) - 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).
Timepoint [4] 0 0
Up to 5 years
Secondary outcome [5] 0 0
Overall Survival (OS) - OS was defined as the time between randomization and death. Death of a participant regardless of the cause was considered as an event.
Timepoint [5] 0 0
Up to 5 years
Secondary outcome [6] 0 0
Consolidation Phase: Change From Baseline in AQOL-6D Scores at the End of the Consolidation Phase - 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).
Timepoint [6] 0 0
Baseline, Month 12
Secondary outcome [7] 0 0
Consolidation Phase: Change From Baseline in FACT/GOG-NTX Total Score at the End of the Consolidation Phase - 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.
Timepoint [7] 0 0
Baseline, Month 12

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Camperdown
Recruitment hospital [3] 0 0
- Geelong
Recruitment hospital [4] 0 0
- Greenslopes
Recruitment hospital [5] 0 0
- Heidelberg
Recruitment hospital [6] 0 0
- Herston
Recruitment hospital [7] 0 0
- Malvern
Recruitment hospital [8] 0 0
- Melbourne
Recruitment hospital [9] 0 0
- Nedlands
Recruitment hospital [10] 0 0
- Newcastle
Recruitment hospital [11] 0 0
- Prahran
Recruitment hospital [12] 0 0
- Sydney
Recruitment hospital [13] 0 0
- Westmead
Recruitment hospital [14] 0 0
- Woodville South
Recruitment hospital [15] 0 0
- Woolloongabba
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Camperdown
Recruitment postcode(s) [3] 0 0
- Geelong
Recruitment postcode(s) [4] 0 0
- Greenslopes
Recruitment postcode(s) [5] 0 0
- Heidelberg
Recruitment postcode(s) [6] 0 0
- Herston
Recruitment postcode(s) [7] 0 0
- Malvern
Recruitment postcode(s) [8] 0 0
- Melbourne
Recruitment postcode(s) [9] 0 0
- Nedlands
Recruitment postcode(s) [10] 0 0
- Newcastle
Recruitment postcode(s) [11] 0 0
- Prahran
Recruitment postcode(s) [12] 0 0
- Sydney
Recruitment postcode(s) [13] 0 0
- Westmead
Recruitment postcode(s) [14] 0 0
- Woodville South
Recruitment postcode(s) [15] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Beijing
Country [2] 0 0
China
State/province [2] 0 0
Guangzhou
Country [3] 0 0
China
State/province [3] 0 0
Shanghai
Country [4] 0 0
China
State/province [4] 0 0
Tianjin
Country [5] 0 0
Korea, Republic of
State/province [5] 0 0
Busan
Country [6] 0 0
Korea, Republic of
State/province [6] 0 0
Daegu
Country [7] 0 0
Korea, Republic of
State/province [7] 0 0
Hwasun Gun
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Ulsan

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Scientific Affairs, LLC
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01539083
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Asia-Pacific Medical Affairs Clinical Trial
Address 0 0
Janssen Asia-Pacific Medical Affairs
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications