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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01266811




Registration number
NCT01266811
Ethics application status
Date submitted
23/12/2010
Date registered
24/12/2010
Date last updated
28/01/2013

Titles & IDs
Public title
A Phase 3 Study of Siltuximab or Placebo in Combination With Velcade and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
Scientific title
A Phase 3, Randomized, Double-blind Study of Siltuximab (Anti-IL-6 Monoclonal Antibody) or Placebo in Combination With VELCADE and Dexamethasone for the Treatment of Subjects With Relapsed or Refractory Multiple Myeloma
Secondary ID [1] 0 0
CNTO328MMY3001
Secondary ID [2] 0 0
CR017743
Universal Trial Number (UTN)
Trial acronym
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 - Placebo, Velcade and dexamethasone
Other interventions - Siltuximab, Velcade and dexamethasone

Experimental: 001 - Siltuximab Velcade and dexamethasone Given in 21-day treatment cycles Siltuximab 11 mg/kg as 1 hour IV infusion on Day 1 of every cycle Velcade 1.3 mg/m2 IV push on Days 1 4 8 and 11 for Cycles 1-8 and on Days 1 and 8 for Cycles 9 and higher Dexamethasone 20 mg orally on the day of and the day after each Velcade dose

Other: 002 - Placebo Velcade and dexamethasone Given in 21-day treatment cycles Placebo as 1-hour IV infusion on Day 1 of every cycle Velcade 1.3 mg/m2 IV push on Days 1 4 8 and 11 for Cycles 1-8 and on Days 1 and 8 for Cycles 9 and higher Dexamethasone 20 mg orally on the day of and the day after each Velcade dose


Treatment: Drugs: Placebo, Velcade and dexamethasone
Siltuximab 11 mg/kg as 1 hour IV infusion on Day 1 of every cycle

Other interventions: Siltuximab, Velcade and dexamethasone
Given in 21-day treatment cycles

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS)
Timepoint [1] 0 0
Event driven, i.e. every 3-4 weeks until progression, death, or end of study (5 years after first patient is dosed)
Secondary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
Every 3 months until death or end of study (5 years after 1st patient is dosed)
Secondary outcome [2] 0 0
Overall response rate
Timepoint [2] 0 0
Every 3 weeks until disease progression or end of study (5 years after 1st patient is dosed)
Secondary outcome [3] 0 0
Siltuximab pharmacokinetic evaluations (Cmin, Cmax) to provide information on the pharmacokinetic profile of siltuximab
Timepoint [3] 0 0
Day 1 of Cycles 1, 2, 3, 5, 7, 11, 15, and 19 and during the follow-up period (12 weeks after last dose)
Secondary outcome [4] 0 0
Dexamethasone pharmacokinetic evaluations (Cmin, AUC[t1-t2]) from approx. 30 patients from each treatment arm to provide information on the pharmacokinetic profile of dexamethasone
Timepoint [4] 0 0
Pre-dose on Day 1 of Cycles 1, 2 and 3; at Cycle 3 measured 1, 2, 4, 6 and 24 hours after dose
Secondary outcome [5] 0 0
Number of adverse events as a measure of safety and tolerability
Timepoint [5] 0 0
Routinely until 30 days after last dose at a minimum, or until end of study

Eligibility
Key inclusion criteria
- Confirmed diagnosis of multiple myeloma requiring treatment

- Measurable secretory disease, defined as either serum M-protein >=1 g/dL or urine
M-protein (light chain) >=¿200 mg/24 hours

- Must have received 1 to 3 lines of prior treatment for multiple myeloma

- Must have achieved a response (Minimal Response or better) to at least 1 prior line of
treatment

- Must have progressed on or been refractory (defined as < Minimal Response or disease
progression within 60 days of last dose) to the most recent line of treatment

- Must not be refractory to any previous line of treatment that included a proteasome
inhibitor

- Qualifying hematology and chemistry laboratory results.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Diagnosis of primary amyloidosis, plasma cell leukemia, or other conditions in which a
paraprotein is present in the absence of a clonal plasma cell infiltration with lytic
bone lesions

- Grade 1 peripheral neuropathy with pain or Grade 2 or higher peripheral neuropathy

- Allogeneic bone marrow transplantation within 28 days

- Bone marrow transplant planned within 12 months after study start

- Chemotherapy or radiation therapy within 21 days

- Clinically significant infection, including known HIV or hepatitis C infection, or
known hepatitis B surface antigen positivity

- Major surgery within 21 days before or planned during the study

- Subjects who the investigator believes would not tolerate starting doses of VELCADE or
dexamethasone

- Significant cardiac disease or myocardial infarction within 6 months

- Vaccination with live attenuated vaccines within 4 weeks

- Prior exposure to agents targeting IL-6 or the IL-6 receptor

- Received any investigational agent within 30 days¿

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
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
- Heidelberg
Recruitment hospital [4] 0 0
- Parkville
Recruitment hospital [5] 0 0
- Prahran
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Camperdown
Recruitment postcode(s) [3] 0 0
- Heidelberg
Recruitment postcode(s) [4] 0 0
- Parkville
Recruitment postcode(s) [5] 0 0
- Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Iowa
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Ohio
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
Wisconsin
Country [6] 0 0
Belgium
State/province [6] 0 0
Edegem
Country [7] 0 0
Belgium
State/province [7] 0 0
Liège
Country [8] 0 0
Belgium
State/province [8] 0 0
Turnhout
Country [9] 0 0
Belgium
State/province [9] 0 0
Yvoir
Country [10] 0 0
Bulgaria
State/province [10] 0 0
Plovdiv N/A
Country [11] 0 0
Bulgaria
State/province [11] 0 0
Sofia
Country [12] 0 0
Bulgaria
State/province [12] 0 0
Varna
Country [13] 0 0
Canada
State/province [13] 0 0
Toronto
Country [14] 0 0
Czech Republic
State/province [14] 0 0
Hradec Kralove
Country [15] 0 0
Czech Republic
State/province [15] 0 0
Liberec
Country [16] 0 0
Czech Republic
State/province [16] 0 0
Praha 2
Country [17] 0 0
Czech Republic
State/province [17] 0 0
Praha
Country [18] 0 0
India
State/province [18] 0 0
Gandhinagar Guiarat
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Hwasun Gun
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Seoul
Country [21] 0 0
Netherlands
State/province [21] 0 0
Apeldoorn
Country [22] 0 0
Netherlands
State/province [22] 0 0
Deventer
Country [23] 0 0
Netherlands
State/province [23] 0 0
Zwolle
Country [24] 0 0
New Zealand
State/province [24] 0 0
Christchurch
Country [25] 0 0
New Zealand
State/province [25] 0 0
Grafton
Country [26] 0 0
New Zealand
State/province [26] 0 0
Nz 9 Takapuna Auckland
Country [27] 0 0
New Zealand
State/province [27] 0 0
Palmerston North
Country [28] 0 0
Poland
State/province [28] 0 0
Brzozow
Country [29] 0 0
Poland
State/province [29] 0 0
Gdansk
Country [30] 0 0
Poland
State/province [30] 0 0
Lodz
Country [31] 0 0
Poland
State/province [31] 0 0
Opole
Country [32] 0 0
Poland
State/province [32] 0 0
Wroclaw
Country [33] 0 0
Turkey
State/province [33] 0 0
Ankara
Country [34] 0 0
Turkey
State/province [34] 0 0
Bursa
Country [35] 0 0
Turkey
State/province [35] 0 0
Edirne
Country [36] 0 0
Ukraine
State/province [36] 0 0
Cherkassy
Country [37] 0 0
Ukraine
State/province [37] 0 0
Dnepropetrovsk
Country [38] 0 0
Ukraine
State/province [38] 0 0
Kharkov
Country [39] 0 0
Ukraine
State/province [39] 0 0
Khmelnitskiy
Country [40] 0 0
Ukraine
State/province [40] 0 0
Kiev
Country [41] 0 0
Ukraine
State/province [41] 0 0
Odessa
Country [42] 0 0
Ukraine
State/province [42] 0 0
Simferopol
Country [43] 0 0
Ukraine
State/province [43] 0 0
Vinnitsa
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Centocor, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine if there is an improvement in progression-free
survival (length of time during and after treatment in which a patient is living with a
disease that does not get worse) when siltuximab is added to VELCADE and dexamethasone in
subjects with relapsed or refractory multiple myeloma.
Trial website
https://clinicaltrials.gov/show/NCT01266811
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Centocor, Inc. Clinical Trial
Address 0 0
Centocor, Inc.
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
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01266811