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A Phase I, Open-Label, Dose-escalation, Multicentre Study of KW-2478 Administered as a Single Agent Intravenously in a Consecutive Dosing Schedule in Patients With Relapsed/Refractory Multiple Myeloma, Chronic Lymphocytic Leukaemia or B-cell Non-Hodgkin's Lymphoma


Phase 1
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma, Chronic Lymphocytic Leukaemia, Lymphoma, B-Cell

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Trial Information

A Phase I, Open-Label, Dose-escalation, Multicentre Study of KW-2478 Administered as a Single Agent Intravenously in a Consecutive Dosing Schedule in Patients With Relapsed/Refractory Multiple Myeloma, Chronic Lymphocytic Leukaemia or B-cell Non-Hodgkin's Lymphoma


This is a Phase I, open-label, dose-escalation study of KW-2478 in patients with
relapsed/refractory multiple myeloma, chronic lymphocytic leukaemia or B-cell Non-Hodgkin's
lymphoma who have no established therapeutic alternatives. Up to 42 patients will be
enrolled at up to six investigational sites over a period of approximately 12 months until
an MTD is reached. An additional 12 patients may be enrolled at the MTD in an expanded
cohort of one or more of the eligible conditions.


Inclusion Criteria:



1. Patients with a confirmed diagnosis of Multiple Myeloma, Chronic Lymphocytic
Leukaemia, or B-cell Non-Hodgkin's Lymphoma, who have had at least two prior standard
treatment regimens and are without established therapeutic alternatives.

2. Signed IEC-approved informed consent

3. ECOG performance status of 0, 1 or 2;

4. Life expectancy of at least 3 months;

5. Adequate haematologic status, liver function and renal function

6. Patients of reproductive potential must agree to follow accepted birth control
methods during the study

Exclusion Criteria:

1. No anti-cancer treatment for ≥ 3 weeks prior to receiving study drug

2. Any other severe, acute or chronic illness

3. No other prior or concurrent malignancy

4. Immunosuppressant therapy

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine Safety & Tolerability by adverse event rates in order to determine recommended Phase II dose

Outcome Time Frame:

At every visit and at the end of each 14-day treatment cycle

Safety Issue:

Yes

Principal Investigator

Responsible Medical Officer KHKUK

Investigator Role:

Study Director

Investigator Affiliation:

Kyowa Hakko Kirin UK

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

2478-EU-001

NCT ID:

NCT00457782

Start Date:

April 2007

Completion Date:

January 2011

Related Keywords:

  • Multiple Myeloma
  • Chronic Lymphocytic Leukaemia
  • Lymphoma, B-Cell
  • Cancer
  • Blood disorders
  • Leukaemia, Adult Chronic
  • Lymphoma
  • Multiple Myeloma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Lymphoma, B-Cell

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