Multiple MyelomaPhase 1NCT00457782
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 1 study testing KW-2478 in people with Multiple Myeloma and Chronic Lymphocytic Leukaemia, run by Kyowa Kirin Co., Ltd. at 6 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Chronic Lymphocytic Leukaemia, B-cell Non-Hodgkin's Lymphoma
- What is being tested?
- KW-2478
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- Apr 2007to Jan 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Signed IEC-approved informed consent
- ECOG performance status of 0, 1 or 2;
- Life expectancy of at least 3 months;
- Adequate haematologic status, liver function and renal function
- Patients of reproductive potential must agree to follow accepted birth control methods during the study
Who cannot join
- No anti-cancer treatment for ≥ 3 weeks prior to receiving study drug
- Any other severe, acute or chronic illness
- No other prior or concurrent malignancy
- Immunosuppressant therapy
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
St Bartholomew's Hospital
London
UCLH
London
Christie Hospital
Manchester
Nottingham University NHS Trust
Nottingham
Cancer Research UK Clinical Centre
Southampton
Royal Marsden Hospital
Sutton
About this study
Official title: 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
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.
Read the 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.
- Being tested
- KW-2478
- Keywords
- Cancer, Blood disorders, Leukaemia, Adult Chronic, Lymphoma, Multiple Myeloma
- Medical subject headings
- Multiple Myeloma, Leukemia, B-Cell, Lymphoma, B-Cell, Neoplasms, Hematologic Diseases, Leukemia, Bronchiolitis Obliterans Syndrome, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KW-2478Drug
Daily intravenous KW-2478 for 5 days in 14-day cycles, ascending dose cohorts
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Intravenous KW-2478 (ascending dose cohorts) Receives: Drug: KW-2478 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine Safety & Tolerability by adverse event rates in order to determine recommended Phase II dose
Measured: At every visit and at the end of each 14-day treatment cycle
Secondary outcomes (1)
Pharmacokinetics and Pharmacodynamics
Measured: At baseline and steady state during cycle 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionAug 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Kyowa Kirin Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kyowa Hakko Kirin UK, Ltd.
- Responsible party
- Sponsor
- Investigators
- Responsible Medical Officer KHKUK, Study director, Kyowa Hakko Kirin UKJ D Cavenagh, MD. MRCP, MRCPath, Principal investigator, St Bartholomew's Hospital, London, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00457782
- Sponsor's protocol ID
- 2478-EU-001
- Status last verified
- Apr 2024
- First submitted
- 5 Apr 2007
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00457782
- Acronym / sponsor ID
- 2478-EU-001
- Keywords
- Cancer, Blood disorders, Leukaemia, Adult Chronic, Lymphoma, Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Kyowa Hakko Kirin UK, Ltd.
- Study start
- Apr 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 6 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Drug: KW-2478Intravenous KW-2478 (ascending dose cohorts) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Signed IEC-approved informed consent
- ECOG performance status of 0, 1 or 2;
- Life expectancy of at least 3 months;
- Adequate haematologic status, liver function and renal function
Key exclusion criteria (4 listed)
- No anti-cancer treatment for ≥ 3 weeks prior to receiving study drug
- Any other severe, acute or chronic illness
- No other prior or concurrent malignancy
- Immunosuppressant therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KW-2478Daily intravenous KW-2478 for 5 days in 14-day cycles, ascending dose cohorts | Drug | I |
Primary outcome
To determine Safety & Tolerability by adverse event rates in order to determine recommended Phase II dose
Time frame: At every visit and at the end of each 14-day treatment cycle
1 secondary outcome
Pharmacokinetics and Pharmacodynamics
Time frame: At baseline and steady state during cycle 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Responsible Medical Officer KHKUK study director
Kyowa Hakko Kirin UK
J D Cavenagh, MD. MRCP, MRCPath principal investigator
St Bartholomew's Hospital, London, UK
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KW-2478 in people with Multiple Myeloma and Chronic Lymphocytic Leukaemia, run by Kyowa Kirin Co., Ltd. at 6 sites in United Kingdom.
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 4 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 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. 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 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?
To determine Safety & Tolerability by adverse event rates in order to determine recommended Phase II dose (time frame: At every visit and at the end of each 14-day treatment cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2024.