Multiple MyelomaPhase 2NCT00911859
A Study to Compare CNTO 328 (Anti-IL-6 Monoclonal Antibody) and VELCADE-Melphalan-Prednisone (VMP) With VMP Alone in Previously Untreated Multiple Myeloma Patients
A Phase 2 study testing Siltuximab11 mg/kg, Siltuximab 8.3 mg/kg or 11 mg/kg and Velcade (bortezomib) in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 37 sites in 11 countries.
Trial summary
The purpose of this study is to evaluate safety and effectiveness of CNTO 328 (siltuximab) when it is administered together with velcade-melphalan-prednisone (VMP) in comparison with VMP alone in participants with multiple myeloma (a type of cancer that affects the blood and bone marrow). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Siltuximab11 mg/kg, Siltuximab 8.3 mg/kg or 11 mg/kg and Velcade (bortezomib)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 37 sitesin 11 countries
- Study dates
- Jun 2009to Apr 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of previously untreated multiple myeloma and not a candidate for high dose chemotherapy with stem cell transplantation
- Eastern cooperative oncology group performance status score of less than or equal to 2
- Measurable secretory disease, defined as either serum monoclonal paraprotein greater than or equal to 1 g/dL or urine monoclonal protein greater than 200 mg/24 hours
- Adequate laboratory results that will be confirmed by a study physician
- Agrees to protocol-defined use of effective contraception
Who cannot join
- Diagnosed with primary amyloidosis, asymptomatic or smoldering multiple myeloma or monoclonal gammopathy of undetermined significance
- Diagnosed with Waldenstrom's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
- Received prior or current systemic therapy or stem cell transplantation for multiple myeloma
- Peripheral neuropathy or neuropathic pain (Grade 2 or higher)
- Received radiation therapy, plasmapheresis or surgery within 14 days
- Transplanted solid organ, with the exception of a corneal transplant
- Serious concurrent illness or history of uncontrolled heart disease
Trial locations and contacts
37 sites in 11 countries.
37 sites in 11 countries
India5 sites
Study site
Ahmedabad
Study site
Calicut
Study site
Hyderabad
Study site
Jaipur
Study site
Mumbai
Israel5 sites
Study site
Afula
Study site
Haifa
Study site
Jerusalem
Study site
Petah Tikva
Study site
Ramat Gan
Poland5 sites
Study site
Bialystok
Study site
Chorzów
Study site
Gdynia
Study site
Lodz
Study site
Wroclaw
United States4 sites
Study site
Boston, Massachusetts
Study site
Chapel Hill, North Carolina
Study site
Houston, Texas
Study site
Philadelphia, Pennsylvania
Russia4 sites
Study site
Arkhangelsk
Study site
Moscow
Study site
Nizhny Novgorod
Study site
Saint Petersburg
Spain4 sites
Study site
Barcelona
Study site
Madrid
Study site
Murcia
Study site
Salamanca
About this study
Official title: A Randomized, Open-Label, Phase 2 Study of CNTO 328 (Anti-IL-6 Monoclonal Antibody) and VELCADE-Melphalan-Prednisone Compared With VELCADE-Melphalan-Prednisone for the Treatment of Previously Untreated Multiple Myeloma
The purpose of this study is to evaluate safety and effectiveness of CNTO 328 (siltuximab) when it is administered together with velcade-melphalan-prednisone (VMP) in comparison with VMP alone in participants with multiple myeloma (a type of cancer that affects the blood and bone marrow).
Read the detailed description
The study will be conducted in 2 parts (Part 1 and Part 2) and will consist of screening period up to 2 weeks; treatment period; maintenance period (CNTO 328 hereafter referred to as siltuximab) for a maximum of 18 months and follow up period until the study ends. Part 1 is an open-label (all people know the identity of the intervention), single group safety lead-in part to evaluate the safety of siltuximab. Approximately 12 patients will be treated with siltuximab in combination with VMP. If the safety profile of the combination is acceptable, the study will proceed to Part 2. Part 2 is a randomized (the study medication is assigned by chance), open-label, 2-arm (Arm A: siltuximab + VMP; Arm B: VMP alone) study. Approximately 104 patients will be equally randomized, followed by a maintenance period with siltuximab in particiants in Arm A who achieve a partial response (PR) or better. Particiants in both parts of the study will be treated up to a maximum of nine 6-week cycles provided there is no evidence of disease progression, unacceptable toxicity, or withdrawal from treatment. Study medication will be continued for at least 2 additional cycles after confirmation of complete response, and preferably for the full 9 cycles of the treatment period. Participants who will be receiving maintenance treatment after the 12-month effectiveness analysis may continue to receive treatment with siltuximab only after careful consideration by the treating physician and on evidence of clinical benefit and in the absence of unwarranted toxicities. Safety assessments will include evaluation of adverse events, clinical laboratory tests, eastern cooperative oncology group performance status, electrocardiogram, vital signs, and physical examination which will be monitored throughout the study.
- Conditions
- Multiple Myeloma
- Being tested
- Siltuximab11 mg/kg, Siltuximab 8.3 mg/kg or 11 mg/kg, Velcade (bortezomib), Melphalan, Prednisone
- Keywords
- Multiple Myeloma, CNTO328, Interleukin-6 (IL-6), Monoclonal antibody, Anti-IL-6 monoclonal antibody, Bortezomib, Velcade, Melphalan, Prednisone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Siltuximab11 mg/kgDrug
Also called CNTO 328
Participants will receive siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks in Part 1.
Siltuximab 8.3 mg/kg or 11 mg/kgDrug
Also called CNTO 328
Participants will receive siltuximab 8.3 mg/kg or 11 mg/kg as a 1-hour intravenous infusion every 3 weeks for 9 cycles of treatment in Part 2, Arm A and in maintenance period.
Velcade (bortezomib)Drug
Also called bortezomib
Participants will receive Velcade 1.3 mg/m2 as an intravenous bolus injection according to the current approved package insert in Part 1.
Velcade (bortezomib)Drug
Also called bortezomib
Participants will receive Velcade 1.3 mg/m2 as an intravenous bolus injection for 9 cycles of the treatment period in Part 2. It will be administered twice weekly for first 4 cycles (on Days 1, 4, 8, 11, 22, 25, 29, and 32, followed by a 10-day rest period) and once weekly for next 5 cycles (on Days 1, 8, 22, and 29, followed by a 13-day rest period)
MelphalanDrug
Participants will take melphalan 9 mg/m2 will be administered orally on Days 1 to 4, followed by a 38-day rest period in Part 1.
MelphalanDrug
Participants will receive melphalan according to currently approved package inserts. Melphalan 9 mg/m2 will be administered orally for 9 cycles of treatment period in Part 2, Arm A.
PrednisoneDrug
Participants will take prednisone 60 mg/m2 will be administered orally on Days 1 to 4, followed by a 38-day rest period in Part 1.
PrednisoneDrug
Participants will take prednisone 60 mg/m2 orally for 9 cycles of treatment period in Part 2, Arm A.
Velcade (bortezomib)Drug
Also called bortezomib
Participants will receive Velcade 1.3 mg/m2 as an intravenous bolus injection according to the current approved package insert.
MelphalanDrug
Participants will take melphalan 9 mg/m2 orally according to currently approved package insert.
PrednisoneDrug
Participants will take prednisone 60 mg/m2 orally according to the package insert.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: VMP+Siltuximab 11 mg/kg | Experimental | Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP (Velcade+Melphalan+Prednisone). Velcade 1.3 mg/m2 will be administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 will be taken orally (by mouth). Receives: Drug: Siltuximab11 mg/kg; Drug: Velcade (bortezomib); Drug: Melphalan; Drug: Prednisone |
| Part 2, Arm A: VMP+Siltuximab 8.3 mg/kg or 11 mg/kg | Experimental | Siltuximab 8.3 mg/kg or 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. Velcade 1.3 mg/m2 will be administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 will be taken orally Receives: Drug: Siltuximab 8.3 mg/kg or 11 mg/kg; Drug: Velcade (bortezomib); Drug: Melphalan; Drug: Prednisone |
| Part 2, Arm B: VMP | Active comparator | Velcade 1.3 mg/m2 will be administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 will be taken orally Receives: Drug: Velcade (bortezomib); Drug: Melphalan; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Achieved Complete Response (CR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria
CR was assessed using EMBT criteria: disappearance of the original monoclonal paraprotein from the blood and urine on at least 2 determinations for a minimum of 6 weeks by immunofixation studies, <5% plasma cells in the bone marrow on at least 1 determination, if skeletal survey is available: no increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response), disappearance of soft tissue plasmacytomas for at least 6 weeks.
Measured: Up to disease progression, approximately 3 years
Secondary outcomes (8)
Percentage of Participants Who Achieved Overall Response ie, Complete Response (CR) or Partial Response (PR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria
CR or PR was assessed using EBMT criteria. CR: disappearance of the original monoclonal paraprotein from the blood and urine on at least 2 determinations for a minimum of 6 weeks by immunofixation studies, <5% plasma cells in the bone marrow on at least 1 determination, if skeletal survey is available: no increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response), disappearance of soft tissue plasmacytomas for at least 6 weeks; PR: >=50% reduction in the level of serum monoclonal paraprotein for at least 2 determinations 6 weeks apart, if present, reduction in 24-hour urinary light chain excretion by either >=90% or to <200 mg for at least 2 determinations 6 weeks apart, >=50% reduction in the size of soft tissue plasmacytomas (by clinical or radiographic examination) for at least 6 weeks, if skeletal survey is available: no increase in size or number of lytic bone lesions
Measured: Up to disease progression, approximately 3 years
Percentage of Participants Who Achieved Stringent Complete Response (sCR) - International Myeloma Working Group (IMWG) Criteria
sCR was assesses by IMWG Criteria: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, <=5% plasma cells in bone marrow, normal free light chain ratio, absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. sCR is a CR that has been confirmed by immunofixation + free light chain assay + either bone marrow immunohistochemistry or immunofluorescence
Measured: Up to disease progression, approximately 3 years
Progression-Free Survival (PFS)
PFS was defined as the time between randomization and either disease progression or death, whichever occurred first.
Measured: From the date of randomization until disease progression or death, whichever occurred first, as assessed up to the last efficacy assessment for disease progression (approximately 3 years)
1-year Progression-Free Survival (PFS) Rate
The 1-year PFS rate was defined as the percentage of participants surviving 1 year after randomization without disease progression or death.
Measured: 1 year
Duration of Response (DOR)
DOR was defined as length from the earliest date a participant achieved a complete response (CR) or partial response (PR) to either date for disease progression (including relapse from CR) or the censoring date for progressive disease. Responders without disease progression were censored at the last efficacy assessment for disease progression.
Measured: From the date participants achieved CR or PR to either date for disease progression (including relapse from CR) or the censoring date for progressive disease, as assessed Up to 30 days after last dose of study medication
1-year Survival Rate
Percentage of participants who are alive at the end of year 1 after randomization
Measured: 1 year
Overall Survival
Overall survival is defined as the time interval in days between the date of randomization and the participant's death from any cause.
Measured: From the date of randomization till the date of death, as assessed up to the end of study (approximately 3 years)
Change From Baseline to Cycle 9 in Global Health Status/Quality of Life Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30)
Global health status/quality of life is a subscale of the EORTC QOL C30, which comprises two questions related to overall health/quality of life during the past week. The raw score to each question ranged from 1 (very poor) to 7 (excellent). The raw mean score of health status/quality of life subscale is calculated for each participant and a linear transformation applied to standardize the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") health and quality of life.
Measured: Baseline (Day 1 predose) and Cycle 9 (Week 54)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development L.L.C Clinical Trial, Study director, Janssen Research & Development L.L.C
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00911859
- Sponsor's protocol ID
- CR015901
- Other IDs
- CNTO328MMY2001, 2008-007157-12, 2008
- Status last verified
- Nov 2014
- First submitted
- 29 May 2009
- Last updated
- 18 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
San-Miguel J, Blade J, Shpilberg O, Grosicki S, Maloisel F, Min CK, Polo Zarzuela M, Robak T, Prasad SV, Tee Goh Y, Laubach J, Spencer A, Mateos MV, Palumbo A, Puchalski T, Reddy M, Uhlar C, Qin X, van de Velde H, Xie H, Orlowski RZ. Phase 2 randomized study of bortezomib-melphalan-prednisone with or without siltuximab (anti-IL-6) in multiple myeloma. Blood. 2014 Jun 26;123(26):4136-42. doi: 10.1182/blood-2013-12-546374. Epub 2014 May 15.
PubMed 24833354
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Phase 2 Study of CNTO 328 (Anti-IL-6 Monoclonal Antibody) and VELCADE-Melphalan-Prednisone Compared With VELCADE-Melphalan-Prednisone for the Treatment of Previously Untreated Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00911859
- Acronym / sponsor ID
- CR015901
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, CNTO328, Interleukin-6 (IL-6), Monoclonal antibody, Anti-IL-6 monoclonal antibody, Bortezomib, Velcade, Melphalan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 2 Jun 2009 (estimated)
- Results
- Posted 18 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate safety and effectiveness of CNTO 328 (siltuximab) when it is administered together with velcade-melphalan-prednisone (VMP) in comparison with VMP alone in participants with multiple myeloma (a type of cancer that affects the blood and bone marrow).
Detailed description
The study will be conducted in 2 parts (Part 1 and Part 2) and will consist of screening period up to 2 weeks; treatment period; maintenance period (CNTO 328 hereafter referred to as siltuximab) for a maximum of 18 months and follow up period until the study ends. Part 1 is an open-label (all people know the identity of the intervention), single group safety lead-in part to evaluate the safety of siltuximab. Approximately 12 patients will be treated with siltuximab in combination with VMP. If the safety profile of the combination is acceptable, the study will proceed to Part 2. Part 2 is a randomized (the study medication is assigned by chance), open-label, 2-arm (Arm A: siltuximab + VMP; Arm B: VMP alone) study. Approximately 104 patients will be equally randomized, followed by a maintenance period with siltuximab in particiants in Arm A who achieve a partial response (PR) or better. Particiants in both parts of the study will be treated up to a maximum of nine 6-week cycles provided there is no evidence of disease progression, unacceptable toxicity, or withdrawal from treatment. Study medication will be continued for at least 2 additional cycles after confirmation of complete response, and preferably for the full 9 cycles of the treatment period. Participants who will be receiving maintenance treatment after the 12-month effectiveness analysis may continue to receive treatment with siltuximab only after careful consideration by the treating physician and on evidence of clinical benefit and in the absence of unwarranted toxicities. Safety assessments will include evaluation of adverse events, clinical laboratory tests, eastern cooperative oncology group performance status, electrocardiogram, vital signs, and physical examination which will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: VMP+Siltuximab 11 mg/kg | Experimental | Drug: Siltuximab11 mg/kg, Drug: Velcade (bortezomib), Drug: Melphalan, Drug: PrednisoneSiltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP (Velcade+Melphalan+Prednisone). Velcade 1.3 mg/m2 will be administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 will be taken orally (by mouth). |
| Part 2, Arm A: VMP+Siltuximab 8.3 mg/kg or 11 mg/kg | Experimental | Drug: Siltuximab 8.3 mg/kg or 11 mg/kg, Drug: Velcade (bortezomib), Drug: Melphalan, Drug: PrednisoneSiltuximab 8.3 mg/kg or 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. Velcade 1.3 mg/m2 will be administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 will be taken orally |
| Part 2, Arm B: VMP | Active comparator | Drug: Velcade (bortezomib), Drug: Melphalan, Drug: PrednisoneVelcade 1.3 mg/m2 will be administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 will be taken orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of previously untreated multiple myeloma and not a candidate for high dose chemotherapy with stem cell transplantation
- Eastern cooperative oncology group performance status score of less than or equal to 2
- Measurable secretory disease, defined as either serum monoclonal paraprotein greater than or equal to 1 g/dL or urine monoclonal protein greater than 200 mg/24 hours
- Adequate laboratory results that will be confirmed by a study physician
- Agrees to protocol-defined use of effective contraception
Key exclusion criteria (7 listed)
- Diagnosed with primary amyloidosis, asymptomatic or smoldering multiple myeloma or monoclonal gammopathy of undetermined significance
- Diagnosed with Waldenstrom's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
- Received prior or current systemic therapy or stem cell transplantation for multiple myeloma
- Peripheral neuropathy or neuropathic pain (Grade 2 or higher)
- Received radiation therapy, plasmapheresis or surgery within 14 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Siltuximab11 mg/kgAlso: CNTO 328Participants will receive siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks in Part 1. | Drug | Part 1: VMP+Siltuximab 11 mg/kg |
| Siltuximab 8.3 mg/kg or 11 mg/kgAlso: CNTO 328Participants will receive siltuximab 8.3 mg/kg or 11 mg/kg as a 1-hour intravenous infusion every 3 weeks for 9 cycles of treatment in Part 2, Arm A and in maintenance period. | Drug | Part 2, Arm A: VMP+Siltuximab 8.3 mg/kg or 11 mg/kg |
| Velcade (bortezomib)Also: bortezomibParticipants will receive Velcade 1.3 mg/m2 as an intravenous bolus injection according to the current approved package insert in Part 1. | Drug | Part 1: VMP+Siltuximab 11 mg/kg |
| Velcade (bortezomib)Also: bortezomibParticipants will receive Velcade 1.3 mg/m2 as an intravenous bolus injection for 9 cycles of the treatment period in Part 2. It will be administered twice weekly for first 4 cycles (on Days 1, 4, 8, 11, 22, 25, 29, and 32, followed by a 10-day rest period) and once weekly for next 5 cycles (on Days 1, 8, 22, and 29, followed by a 13-day rest period) | Drug | Part 2, Arm A: VMP+Siltuximab 8.3 mg/kg or 11 mg/kg |
| MelphalanParticipants will take melphalan 9 mg/m2 will be administered orally on Days 1 to 4, followed by a 38-day rest period in Part 1. | Drug | Part 1: VMP+Siltuximab 11 mg/kg |
| MelphalanParticipants will receive melphalan according to currently approved package inserts. Melphalan 9 mg/m2 will be administered orally for 9 cycles of treatment period in Part 2, Arm A. | Drug | Part 2, Arm A: VMP+Siltuximab 8.3 mg/kg or 11 mg/kg |
| PrednisoneParticipants will take prednisone 60 mg/m2 will be administered orally on Days 1 to 4, followed by a 38-day rest period in Part 1. | Drug | Part 1: VMP+Siltuximab 11 mg/kg |
| PrednisoneParticipants will take prednisone 60 mg/m2 orally for 9 cycles of treatment period in Part 2, Arm A. | Drug | Part 2, Arm A: VMP+Siltuximab 8.3 mg/kg or 11 mg/kg |
| Velcade (bortezomib)Also: bortezomibParticipants will receive Velcade 1.3 mg/m2 as an intravenous bolus injection according to the current approved package insert. | Drug | Part 2, Arm B: VMP |
| MelphalanParticipants will take melphalan 9 mg/m2 orally according to currently approved package insert. | Drug | Part 2, Arm B: VMP |
| PrednisoneParticipants will take prednisone 60 mg/m2 orally according to the package insert. | Drug | Part 2, Arm B: VMP |
Primary outcome
Percentage of Participants Who Achieved Complete Response (CR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria
Time frame: Up to disease progression, approximately 3 years
CR was assessed using EMBT criteria: disappearance of the original monoclonal paraprotein from the blood and urine on at least 2 determinations for a minimum of 6 weeks by immunofixation studies, <5% plasma cells in the bone marrow on at least 1 determination, if skeletal survey is available: no increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response), disappearance of soft tissue plasmacytomas for at least 6 weeks.
8 secondary outcomes
Percentage of Participants Who Achieved Overall Response ie, Complete Response (CR) or Partial Response (PR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria
Time frame: Up to disease progression, approximately 3 years
Percentage of Participants Who Achieved Stringent Complete Response (sCR) - International Myeloma Working Group (IMWG) Criteria
Time frame: Up to disease progression, approximately 3 years
Progression-Free Survival (PFS)
Time frame: From the date of randomization until disease progression or death, whichever occurred first, as assessed up to the last efficacy assessment for disease progression (approximately 3 years)
1-year Progression-Free Survival (PFS) Rate
Time frame: 1 year
Duration of Response (DOR)
Time frame: From the date participants achieved CR or PR to either date for disease progression (including relapse from CR) or the censoring date for progressive disease, as assessed Up to 30 days after last dose of study medication
1-year Survival Rate
Time frame: 1 year
Overall Survival
Time frame: From the date of randomization till the date of death, as assessed up to the end of study (approximately 3 years)
Change From Baseline to Cycle 9 in Global Health Status/Quality of Life Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30)
Time frame: Baseline (Day 1 predose) and Cycle 9 (Week 54)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24833354San-Miguel J, Blade J, Shpilberg O, Grosicki S, Maloisel F, Min CK, Polo Zarzuela M, Robak T, Prasad SV, Tee Goh Y, Laubach J, Spencer A, Mateos MV, Palumbo A, Puchalski T, Reddy M, Uhlar C, Qin X, van de Velde H, Xie H, Orlowski RZ. Phase 2 randomized study of bortezomib-melphalan-prednisone with or without siltuximab (anti-IL-6) in multiple myeloma. Blood. 2014 Jun 26;123(26):4136-42. doi: 10.1182/blood-2013-12-546374. Epub 2014 May 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development L.L.C Clinical Trial study director
Janssen Research & Development L.L.C
37 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Siltuximab11 mg/kg, Siltuximab 8.3 mg/kg or 11 mg/kg and Velcade (bortezomib) in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 37 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in India, Israel, Poland, United States, Russia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Achieved Complete Response (CR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria (time frame: Up to disease progression, approximately 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00911859, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2014.