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Multiple MyelomaPhase 1NCT01309412

A Phase 1 Study of CNTO 328 (Siltuximab) in Relapsed or Refractory Multiple Myeloma

A Phase 1 study testing Siltuximab in people with Multiple Myeloma, run by Janssen Pharmaceutical K.K. at 5 sites in Japan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to assess the safety and the tolerability of siltuximab up to 11.0 mg/kg in combination with bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Siltuximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
5 sitesJapan
Study dates
Jan 2011to Dec 2012
Phase
Phase 1
Are there results?
None posted in the registry

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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients proven to have symptomatic or nonsecretory multiple myeloma
  • Patients with a measurable lesion
  • Patients who have previously received 1-3 regimens for multiple myeloma
  • Patients must have progressed on or be refractory to the most recent line of treatment
  • Patients with Eastern Cooperative Oncology Group performance status of 0-2
  • Patients having the following laboratory values within 14 days before the scheduled day of initial administration of the study drug: hemoglobin 8 g/dL or more, absolute neutrophil count 1,000/mm3 or more, platelet count 50,000/mm3 or more, aspartate aminotransferase, and alanine aminotransferase 2.5 times or more of upper limit of normal range, total bilirubin 1.5 times or more of upper limit of normal range, calculated creatinine clearance 20 mL/min or more, corrected serum calcium less than 12.5 mg/dL

Who cannot join

  • Patients with primary amyloidosis, plasma cell leukemia or other conditions in which M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
  • Patients with Grade 1 peripheral neuropathy with pain or Grade 2 or higher peripheral neuropathy
  • Patients who have undergone allogeneic bone marrow transplantation within 28 days before the start of treatment with the study drug
  • Patients who have been exposed to agents targeting interleukin-6 (IL-6) or the IL-6 receptor
  • Patients refractory to bortezomib
  • Patients having treatment discontinued because of the toxicity of bortezomib
Show all 15Show fewer
  • Patients requiring dose reduction because of the toxicity of bortezomib
  • Patients who have received chemotherapy, plasmapheresis or radiation therapy within 21 days before the start of treatment (within 42 days for nitrosoureas)
  • Patients who have undergone major surgery including open biopsy (excluding bone marrow) within 21 days before study treatment or planning to have surgery (except for minor surgical procedures) during the study
  • Human immunodeficiency virus antibody-positive, hepatitis C virus antibody-positive or hepatitis B surface antigen-positive patients
  • Patients with known hypersensitivity to boron or mannitol
  • Patients with a history of unmanageable severe infusion reactions to monoclonal antibodies or to murine, chimeric or human proteins or their excipients
  • Patients with concurrent medical condition that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in the study
  • Patients with significant cardiac disease characterized by significant ischemic coronary disease, significant arrhythmias, or congestive heart failure (New York Heart Association Class III or IV) or myocardial infarction within 6 months before the first dose of study drug
  • Patients who are clinically diagnosed with pneumonitis (interstitial pneumonia) or pulmonary fibrosis or have abnormal interstitial shadows bilaterally on chest CT, with or without symptoms

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Japan5 sites

  • Study site

    Isehara

  • Study site

    Kyoto

  • Study site

    Nagoya

  • Study site

    Niigata

  • Study site

    Tokyo

Other trials in Japan

About this study

Official title: A Phase 1 Study of CNTO 328 (Siltuximab) in Combination With Bortezomib and Dexamethasone for Patients With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to assess the safety and the tolerability of siltuximab up to 11.0 mg/kg in combination with bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma.

Read the detailed description

This study is an open-label (both physician and patient know the name of the study drug), multicenter (more than one site) study of siltuximab in patients with relapsed or refractory multiple myeloma receiving siltuximab in combination with bortezomib/dexamethasone to evaluate the safety, pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time), efficacy and immunogenicity (the ability to induce immune responses). This study is planned with a dose escalation of siltuximab to levels of 5.5 mg/kg (Dose Level 1) and 11.0 mg/kg (Dose Level 2) given intravenously. Recommended doses will be determined based on the incidence of dose-limiting toxicity in patients with relapsed or refractory multiple myeloma when siltuximab at dose levels of 5.5 mg/kg and 11.0 mg/kg is administered with bortezomib/dexamethasone. Treatment with siltuximab will be started at Dose Level 1, and treatment at Dose Level 2 will not be started until completing the safety evaluation at the end of the observation period of Cycle 1 for all patients at Dose level 1. Once 11.0 mg/kg is determined as a recommended dose, the dose for patients whose starting dose is 5.5 mg/kg, and who have not achieved complete response, can be escalated to 11.0 mg/kg based on patient consent and investigator discretion in the next cycle. Siltuximab will be given at 5.5 or 11.0 mg/kg by intravenous infusion over 1 hour on Day 1 of each 21-day cycle until progression. Twice-weekly intravenous administration of bortezomib 1.3 mg/m2 (Days 1, 4, 8, and 11) will be followed by a 10-day rest period (Days 12-21). Four-per-week oral administration of dexamethasone 20 mg (Days 1, 2, 4, 5, 8, 9, 11 and 12) will be followed by a 9-day rest period (Days 13-21).

Being tested
Siltuximab
Keywords
Relapsed or refractory multiple myeloma, CNTO 328, siltuximab, bortezomib, dexamethasone
Medical subject headings
Multiple Myeloma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SiltuximabDrug

    5.5 or 11.0 mg/kg by intravenous infusion over 1 hour on Day 1 of each 21-day cycle until progression

Study groups in NCT01309412
Study groupRoleWhat they receive
SiltuximabExperimentalSiltuximab 5.5 or 11.0 mg/kg by intravenous infusion over 1 hour on Day 1 of each 21-day cycle until progression
Receives: Drug: Siltuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with adverse events as a measure of safety and tolerability

    Measured: Up to 14 months

Secondary outcomes (3)

  1. Serum siltuximab concentration

    Measured: Maximum 15 weeks

  2. Number of patients with a positive immune response to siltuximab

    Measured: Up to 14 months

  3. Number of patients with an overall response (complete response and partial response)

    Measured: Up to 14 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionDec 2012
  4. Study completionDec 2012

Why it stopped: Protocol was stopped due to the safety issue in Global

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01309412
Sponsor's protocol ID
CR017737
Other IDs
JPN-C0328-MM-101
Status last verified
May 2014
First submitted
3 Mar 2011
Last updated
19 May 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Suzuki K, Ogura M, Abe Y, Suzuki T, Tobinai K, Ando K, Taniwaki M, Maruyama D, Kojima M, Kuroda J, Achira M, Iizuka K. Phase 1 study in Japan of siltuximab, an anti-IL-6 monoclonal antibody, in relapsed/refractory multiple myeloma. Int J Hematol. 2015 Mar;101(3):286-94. doi: 10.1007/s12185-015-1743-y. Epub 2015 Feb 6.

    PubMed 25655379

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Siltuximab in people with Multiple Myeloma, run by Janssen Pharmaceutical K.K. at 5 sites in Japan.

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 6 inclusion and 15 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: stopped early, as of the sponsor's last update on 19 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Japan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Protocol was stopped due to the safety issue in Global). Results are not available in the source record.

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?

Number of patients with adverse events as a measure of safety and tolerability (time frame: Up to 14 months). 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 NCT01309412, 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 19 May 2014.

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