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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/NCT01484275




Registration number
NCT01484275
Ethics application status
Date submitted
1/12/2011
Date registered
2/12/2011
Date last updated
27/01/2020

Titles & IDs
Public title
A Study of Siltuximab (Anti- IL 6 Monoclonal Antibody) in Patients With High-risk Smoldering Multiple Myeloma
Scientific title
A Phase 2, Randomized, Blinded, Placebo-controlled, Multicenter Study of Siltuximab (Anti IL 6 Monoclonal Antibody) in Subjects With High-risk Smoldering Multiple Myeloma
Secondary ID [1] 0 0
CNTO328SMM2001
Secondary ID [2] 0 0
CR100755
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Siltuximab
Treatment: Drugs - Placebo

Experimental: Siltuximab - Type=exact, unit=mg/kg, number=15, form=intravenous infusion, route=intravenous use, every 4 weeks until progression to symptomatic multiple myeloma, unacceptable toxicity, withdrawal of consent, or the end of the study.

Placebo Comparator: Placebo - Form=intravenous infusion, route=intravenous use route=intravenous, use every 4 weeks until progression to symptomatic multiple myeloma, unacceptable toxicity, withdrawal of consent, or the end of the study.


Treatment: Drugs: Siltuximab
Type=exact, unit=mg/kg, number=15, form=intravenous infusion, route=intravenous use, every 4 weeks until progression to symptomatic multiple myeloma, unacceptable toxicity, withdrawal of consent, or the end of the study.

Treatment: Drugs: Placebo
Form=intravenous infusion, route=intravenous use route=intravenous, use every 4 weeks until progression to symptomatic multiple myeloma, unacceptable toxicity, withdrawal of consent, or the end of the study.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
One-Year Progression-Free Survival (PFS) Rate
Timepoint [1] 0 0
Up to 1 Year
Secondary outcome [1] 0 0
Progressive Disease Indicator Rate (PDIR) at 6 Months
Timepoint [1] 0 0
At 6 Months
Secondary outcome [2] 0 0
Progression-Free Survival
Timepoint [2] 0 0
Up to 4.7 Years
Secondary outcome [3] 0 0
Percentage of Participants With Serum M-protein Response
Timepoint [3] 0 0
Up to 4.7 Years
Secondary outcome [4] 0 0
Time to Worsening in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30) Scale Score
Timepoint [4] 0 0
Up to 4.7 Years
Secondary outcome [5] 0 0
Time to Worsening in the Brief Pain Inventory (BPI) Worst Item Scores
Timepoint [5] 0 0
Up to 4.7 Years
Secondary outcome [6] 0 0
Number of Participants With Symptomatic Multiple Myeloma With Adverse Prognostic Features
Timepoint [6] 0 0
Up to 4.7 Years
Secondary outcome [7] 0 0
Number of Participants With Best Response to First Subsequent Multiple Myeloma Treatment
Timepoint [7] 0 0
Up to 4.7 Years
Secondary outcome [8] 0 0
Overall Survival (OS)
Timepoint [8] 0 0
Up to 4.7 Years

Eligibility
Key inclusion criteria
- Diagnosis of smoldering multiple myeloma (SMM) for <4 years

- Diagnosis of high-risk SMM (defined as bone marrow plasma cells >=10% and either serum
monoclonal protein >=3 g/dL, or abnormal free light chain ratio <0.126 or >8 and serum
M-protein <3 g/dL but >=1 g/dL)

- Patients must be within certain limits for protocol-specified laboratory tests

- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1

- Women not of childbearing potential must be postmenopausal, permanently sterilized, or
otherwise incapable of pregnancy

- Women of childbearing potential must agree to use adequate birth control measures and
agree to not donate eggs for the purpose of assisted reproduction during the study and
for 3 months after receiving the last dose of study agent, and must have a negative
pregnancy test at screening

- Men must agree to use a double-barrier method of birth control and to not donate sperm
during the study and for 3 months after receiving the last dose of study agent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Having symptomatic multiple myeloma, defined by any of the following (if due to
myeloma): lytic bone lesions, severe osteopenia (low bone density), pathologic
fractures, hypercalcemia (too much calcium in the blood), kidney insufficiency;
symptomatic hyperviscosity of the blood, or recurrent serious bacterial infections
such as pneumonia

- Primary systemic amyloid light (AL) chain amyloidosis (a build-up of amyloid light
chain proteins in the blood)

- Prior or concurrent exposure to approved or investigational multiple myeloma
treatments (concurrent treatment with bone-protecting agents (eg, bisphosphonates,
denosumab), or steroids (not exceeding 10 mg prednisone per day or equivalent) are
only allowed if given in a stable dose and for a nonmalignant condition; concurrent
treatment with erythropoietin-stimulating agents (ESAs) are not allowed.)

- Prior exposure to agents targeting interleukin 6 (IL 6) or the IL 6 receptor

- Other malignancy within the past 3 years, except for the following, if treated and not
active: basal cell or nonmetastatic (non-spreading) squamous cell carcinoma of the
skin, cervical carcinoma or International Federation of Gynecology and Obstetrics
Stage 1 carcinoma of the cervix

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
1/03/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/08/2019
Sample size
Target
Accrual to date
Final
85
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- East Melbourne
Recruitment hospital [3] 0 0
- Randwick
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- East Melbourne
Recruitment postcode(s) [3] 0 0
- Randwick
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
South Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Belgium
State/province [8] 0 0
Antwerpen
Country [9] 0 0
Belgium
State/province [9] 0 0
Brussels
Country [10] 0 0
Belgium
State/province [10] 0 0
Gent
Country [11] 0 0
France
State/province [11] 0 0
Dijon
Country [12] 0 0
France
State/province [12] 0 0
Nantes Cedex 1
Country [13] 0 0
France
State/province [13] 0 0
Tours
Country [14] 0 0
France
State/province [14] 0 0
Villejuif
Country [15] 0 0
Germany
State/province [15] 0 0
Berlin
Country [16] 0 0
Germany
State/province [16] 0 0
Hamburg
Country [17] 0 0
Germany
State/province [17] 0 0
Heidelberg
Country [18] 0 0
Greece
State/province [18] 0 0
Athens
Country [19] 0 0
Israel
State/province [19] 0 0
Ashkelon
Country [20] 0 0
Israel
State/province [20] 0 0
Jerusalem
Country [21] 0 0
Israel
State/province [21] 0 0
Nahariya
Country [22] 0 0
Israel
State/province [22] 0 0
Netanya
Country [23] 0 0
Israel
State/province [23] 0 0
Petach Tikva
Country [24] 0 0
Israel
State/province [24] 0 0
Tel Aviv
Country [25] 0 0
Korea, Republic of
State/province [25] 0 0
Daejeon
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Seoul
Country [27] 0 0
Spain
State/province [27] 0 0
Barcelona
Country [28] 0 0
Spain
State/province [28] 0 0
Barcleona
Country [29] 0 0
Spain
State/province [29] 0 0
Madrid
Country [30] 0 0
Spain
State/province [30] 0 0
Salamanca
Country [31] 0 0
Spain
State/province [31] 0 0
Valencia
Country [32] 0 0
Sweden
State/province [32] 0 0
Göteborg
Country [33] 0 0
Sweden
State/province [33] 0 0
Linkoping
Country [34] 0 0
Sweden
State/province [34] 0 0
Stockholm
Country [35] 0 0
United Kingdom
State/province [35] 0 0
London
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Manchester

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety and efficacy of siltuximab compared with
placebo (an inactive substance that is compared with a drug to test whether the drug has a
real effect in a clinical trial) in patients with high-risk smoldering multiple myeloma
(SMM).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01484275
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
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