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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Sex
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
1/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2014
Actual
Sample size
Target
Accrual to date
Final
0
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/ct2/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/ct2/show/NCT01266811