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RefractoryPhase 1/2NCT00752518

A Japan Phase I/II Study of Bortezomib in Relapsed or Refractory Multiple Myeloma Patients

A Phase 1/2 study testing bortezomib in people with Refractory and Multiple Myeloma, run by Janssen Pharmaceutical K.K..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the safety/tolerability and determine the Japanese recommended dose (RD) of bortezomib administered as a once-daily intravenous bolus twice weekly for 2 consecutive weeks(Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 to 21) in Japanese patients with relapsed or… Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Refractory, Multiple Myeloma, Relapse
What is being tested?
bortezomib
How many people
35 participants
Where
No sites listed yet
Study dates
May 2004to Jan 2006
Phase
Phase 1/2
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients diagnosed with multiple myeloma based on the predetermined diagnostic criteria
  • Patients who received at least standard first-line therapy and had documentation of failure to that therapy or relapsed after remission and currently requires therapy because of progressive disease (PD) as assessed by the investigator (subinvestigator) at enrollment. There is no limitation in the number of prior therapies (salvage therapies
  • Number of regimens)
  • Patients with measurable disease, defined as follows: Secretory Multiple myeloma: Quantifiable serum monoclonal protein value (in general, serum M protein values of >= 1.0 g/dL of IgG and >= 0.5 g/dL of IgA.), When M protein is excreted in urine, M protein is quantitatively assayable by urinary protein electrophoresis (in general, urinary M protein excretion of >= 0.2g/day.). Non-secretory Multiple myeloma: Presence of bidimensionally measurable soft tissue masses (plasmacytomas) with a longer diameter of 2cm and more as determined by applicable radiographies (i.e. MRI, CT-scan)
  • Patients with a life expectancy of >= 3 months after initiation of JNJ-26866138 therapy
  • Patients with a Karnofsky Performance Status (PS, general condition) of >= 60
  • Patients aged >=20 and =< 75 at enrollment in the study
  • Patients who can be hospitalized at least from the initial treatment of the study drug to the completion of Cycle 1 (including the 10-day observation period after JNJ-26866138 injection - when the next cycle is delayed because the "conditions for the start of the nextcycle" were not satisfied, patients must be hospitalized until the patient satisfies the criteria (it is possible to transfer patients to treatment on an outpatient basis when the next cycle is delayed due to reasons such as schedule adjustment

Who cannot join

  • Patients with plasma cell leukemia (Definition of plasma cell leukemia: A state in which the proportion of plasma cells in peripheral blood is 20%, with their absolute count being more than 2x10 ^ 9L.)
  • Patients with Crow-Fukase syndrome (multiple neuritis, pigmentation, endocrine disorder, swollen organ, sclerotic bone lesion and, etc.)
  • Patients with peripheral sensory neuropathy of Grade 2 or worse ("neuropathy - sensory" in NCI-CTC Japanese translation JCOG version 2) or those with neuropathic pain of Grade 2 or worse ("neurologic pain" in NCI-CTC Japanese translation JCOG version)
  • Patients who underwent allogeneic hematopoietic stem cell transplantation
  • Patients who underwent two or more consecutive courses of autologous peripheral blood stem cell transplantation (tandem transplantation, etc.)
  • Patients suspected of having cardiac amyloidosis (patients who had a left ventricular ejection fraction (LVEF) of less than 55% by echocardiogram)
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  • Patients with an active infection (fever of .38ºC)
  • Patients with clinical findings of pneumonia (interstitial pneumonia) or pulmonary fibrosis or those having bilateral abnormal interstitial shadows (for example, ground-glass opacities, linear opacities) on chest CT (high resolution CT), regardless of the presence or absence of associated symptoms (consultation with specialists in the respiratory system or other fields was to be held if necessary)
  • Patients with a heart disease of Class III or IV on the New York Heart Association (NYHA) cardiac function classification, patients who had myocardial infarction within 6 months prior to screening, or patients with uncontrolled angina pectris, serious ventricular arrhythmia, acute ischemia, active conduction disorder, or others
  • Patients with a renal disease (chronic glomerulonephritis, diabetic nephropathy, hypertensive nephropathy, gouty nephropathy, etc.) leading to the onset of impaired renal function
  • Patients with uncontrolled hypertension
  • Patients on pharmacotherapy (oral hypoglycemic drug or insulin preparation) for diabetes mellitus

About this study

Official title: A Phase I/II Study of JNJ-26866138 (Bortezomib) in Japanese Patients With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to assess the safety/tolerability and determine the Japanese recommended dose (RD) of bortezomib administered as a once-daily intravenous bolus twice weekly for 2 consecutive weeks(Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 to 21) in Japanese patients with relapsed or refractory multiple myeloma.

Read the detailed description

In Japan, there is no clear treatment guidance for patients with multiple myeloma that repeatedly relapsed and became refractory. At present, various therapies including other multi-drug combination chemotherapy, hematopoietic stem cell transplantation, corticosteroid massive therapy, interferon therapy, thalidomide therapy, radiation therapy and other experimental therapies are conducted exploratory as salvage therapies to find the one to which the patient shows response. Considering that the antitumor activity of JNJ-26866138 against relapsed or refractory MM is clear and and the tolerability is acceptable based on results of the overseas clinical studies, the development of JNJ-26866138 in Japan is quite meaningful. This is a non-randomized, open-label, multicenter dose-escalation study which consisting of the two parts: the Phase I part is intended to intravenously administer JNJ-26866138 twice daily for 2 weeks (Days 1, 4, 8, and 11) to establish the Japanese RD based on the incidence of dose limiting toxicities (DLTs), while the Phase II part is intended to evaluate the efficacy and safety of JNJ-26866138 in patients repeatedly treated at the Japanese RD.

Based on the body surface area calculated before treatment in each cycle, the dose is calculated for each patient according to the dose level specified by the Patient Enrollment Center (0.7mg/m2, 1.0 mg/m2 or 1.3 mg/m2). JNJ-26866138 is intravenously administered once daily, twice weekly for 2 weeks (Days 1, 4, 8, and 11), followed by a 10-day rest period (Days 12 to 21). This is considered one cycle (21 days), and treatment is repeated up to 6 cycles in patients expected to show a response.

Being tested
bortezomib
Keywords
bolus, intravenous, proteasome inhibitor, multiple myeloma, refractory, relapse
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.

What is being measured

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

  1. Phase I: To assess safety/tolerability and determine the Japanese RD of bortezomib. Phase II: part: To evaluate the efficacy and safety of bortezomib in patients repeatedly treated at the Japanese RD.

Secondary outcomes (1)

  1. To determine the plasma concentration of unchanged bortezomib to conduct pharmacokinetic examination, to assess the antitumor activity of bortezomib and to determine the 20S proteasome inhibition in whole blood to conduct pharmacodynamic examination.

Timeline

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

  1. First posted15 Sep 2008 (estimated)
  2. Study startMay 2004
  3. Study completionJan 2006

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00752518
Sponsor's protocol ID
CR009058
Status last verified
Apr 2010
First submitted
11 Sep 2008
Last updated
17 May 2011
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing bortezomib in people with Refractory and Multiple Myeloma, run by Janssen Pharmaceutical K.K..

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 8 inclusion and 12 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 17 May 2011. Status can change between updates, so confirm with the study contact before making plans.

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 combined 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.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Phase I: To assess safety/tolerability and determine the Japanese RD of bortezomib. Phase II: part: To evaluate the efficacy and safety of bortezomib in patients repeatedly treated at the Japanese RD.. 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 NCT00752518.

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 17 May 2011.

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