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

Phase 1/Phase 2
20 Years
75 Years
Not Enrolling
Refractory, Multiple Myeloma, Relapse

Thank you

Trial Information

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

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.

Inclusion Criteria:

- Patients diagnosed with multiple myeloma based on the predetermined diagnostic

- 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

- 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,

- Patients with a life expectancy of >= 3 months after initiation of JNJ-26866138

- 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

Exclusion Criteria:

- 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

- 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)

- Patients with an active infection (fever of .38ÂșC)

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Principal Investigator

Janssen Pharmaceutical K.K. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Pharmaceutical K.K.


Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center

Study ID:




Start Date:

May 2004

Completion Date:

January 2006

Related Keywords:

  • Refractory
  • Multiple Myeloma
  • Relapse
  • bolus
  • intravenous
  • proteasome inhibitor
  • multiple myeloma
  • refractory
  • relapse
  • Multiple Myeloma
  • Neoplasms, Plasma Cell