A Phase I Safety, PK and PD Study of KW-2478 in Patients With Multiple Myeloma, Chronic Lymphocytic Leukaemia or B-cell Non-Hodgkin's Lymphoma

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00457782

Enrollment

Registered

2007-04-06

Start date

2007-04-30

Completion date

2011-01-31

Last updated

2024-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B-cell Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukaemia, Multiple Myeloma

Keywords

Cancer, Blood disorders, Leukaemia, Adult Chronic, Lymphoma, Multiple Myeloma

Brief summary

The aim of this study is to determine the safety, tolerability and dose-limiting toxicities of KW-2478 and to determine the Maximum Tolerated Dose and recommended Phase II dose for patients with relapsed/refractory MM, CLL or B-cell NHL.

Detailed description

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.

Interventions

DRUGKW-2478

Daily intravenous KW-2478 for 5 days in 14-day cycles, ascending dose cohorts

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To determine Safety & Tolerability by adverse event rates in order to determine recommended Phase II dose	At every visit and at the end of each 14-day treatment cycle

Secondary

Measure	Time frame
Pharmacokinetics and Pharmacodynamics	At baseline and steady state during cycle 1

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026