Multiple MyelomaPhase 2NCT00216697
An Extension Study to Provide Bortezomib to Patients With Relapsed or Refractory Multiple Myeloma Who Previously Participated in a Bortezomib Phase I/II Study and Who May Benefit From Re-Treatment With or Continuation of Bortezomib Therapy
A Phase 2 study testing bortezomib in people with Multiple Myeloma, run by Janssen Pharmaceutical K.K..
Trial summary
One purpose of this study is to evaluate the effectiveness and safety in long term treatment for patients who completed preceding phase I/II study. The other purpose is to evaluate the effectiveness and safety of patients who are re-treated with this drug in recommended dose. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- bortezomib
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to Oct 2006
- Phase
- Phase 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Complete 6 cycles treatment in preceding phase I/II study
- response (CR, PR, MR or NC) was obtained in 6 cycles treatment during the preceding phase I/II study and investigator considers that the patient is expected to have benefit such as antitumor effect, pain relief or improvement of performance state
- Patients who did not have Grade >=3 non-hematologic toxicity or Grade 4 hematologic toxicity during the preceding phase I/II study or extension treatment of this study
- Investigator considers that the patient is expected to have benefit of this drug such as antitumor effect, pain relief or improvement of performance state.
Who cannot join
- Patient is known to be HBs antigen positive, HCV antibody positive or HIV antibody positive (check is required for patients who received blood product during phase I/II study)
- Patients who receive G-CSF product or blood transfusion within 7 days before the start of treatment
- Disease progress was observed during the phase I/II or this study when patients receive recommended dose
- Patients who suffer Grade >=2 peripheral neuropathy or Grade >=2 neuropathic pain
- Patient has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, acute ischemia or active conduction system abnormalities.
About this study
Official title: An Extension or Re-Treatment Study of Bortezomib to Patients With Relapsed or Refractory Multiple Myeloma
One purpose of this study is to evaluate the effectiveness and safety in long term treatment for patients who completed preceding phase I/II study. The other purpose is to evaluate the effectiveness and safety of patients who are re-treated with this drug in recommended dose.
Read the detailed description
Multiple myeloma is a kind of malignant disease in the organ which produce blood cells such as bone marrow. It has poor prognosis, especially in patients who are relapsed repeatedly. Effective treatment is strongly expected in such relapsed patients in Japan. This is a open label multiple center study to evaluate the effectiveness and safety of bortezomib. This study is an extension or re-treatment study for patients who were administered with bortezomib in preceding Phase I/II study. For extension treatment, the same dose of the previous study will be administered into a vein as a bolus twice weekly followed by a 10-day rest (3-week cycle). For re-treatment, a recommended dose determined in Phase I/II study will be administered in 3-week cycle.
- Conditions
- Multiple Myeloma
- Being tested
- bortezomib
- Keywords
- Multiple myeloma, Proteasome inhibitor, Ubiquitin, Boronic acids, Bortezomib
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bortezomibDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
No. of patients who had adverse events, incidence and severity of adverse events, and relationship to the study drug. Overall response rate (Complete Remission + Partial Remission). Response will be evaluated by independent review committee.
Secondary outcomes (1)
TTP (Time To Progression), survival time, time to response and duration of response. For re-treatment patients, survival time from the previous study drug treatment and response rate from the start of re-treatment will be also evaluated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMar 2005
- Study completionOct 2006
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen Pharmaceutical K.K. Clinical Trial, Study director, Janssen Pharmaceutical K.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216697
- Sponsor's protocol ID
- CR004843
- Status last verified
- Apr 2010
- First submitted
- 13 Sep 2005
- Last updated
- 17 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension or Re-Treatment Study of Bortezomib to Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00216697
- Acronym / sponsor ID
- CR004843
- Conditions
- Multiple Myeloma
- Keywords
- Multiple myeloma, Proteasome inhibitor, Ubiquitin, Boronic acids, Bortezomib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Janssen Pharmaceutical K.K.Industry (pharma, biotech, devices)
- Study start
- Mar 2005
- Study completion
- Oct 2006 (actual)
- First posted
- 22 Sep 2005 (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.
One purpose of this study is to evaluate the effectiveness and safety in long term treatment for patients who completed preceding phase I/II study. The other purpose is to evaluate the effectiveness and safety of patients who are re-treated with this drug in recommended dose.
Detailed description
Multiple myeloma is a kind of malignant disease in the organ which produce blood cells such as bone marrow. It has poor prognosis, especially in patients who are relapsed repeatedly. Effective treatment is strongly expected in such relapsed patients in Japan. This is a open label multiple center study to evaluate the effectiveness and safety of bortezomib. This study is an extension or re-treatment study for patients who were administered with bortezomib in preceding Phase I/II study. For extension treatment, the same dose of the previous study will be administered into a vein as a bolus twice weekly followed by a 10-day rest (3-week cycle). For re-treatment, a recommended dose determined in Phase I/II study will be administered in 3-week cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Complete 6 cycles treatment in preceding phase I/II study
- response (CR, PR, MR or NC) was obtained in 6 cycles treatment during the preceding phase I/II study and investigator considers that the patient is expected to have benefit such as antitumor effect, pain relief or improvement of performance state
- Patients who did not have Grade >=3 non-hematologic toxicity or Grade 4 hematologic toxicity during the preceding phase I/II study or extension treatment of this study
- Investigator considers that the patient is expected to have benefit of this drug such as antitumor effect, pain relief or improvement of performance state.
Key exclusion criteria (5 listed)
- Patient is known to be HBs antigen positive, HCV antibody positive or HIV antibody positive (check is required for patients who received blood product during phase I/II study)
- Patients who receive G-CSF product or blood transfusion within 7 days before the start of treatment
- Disease progress was observed during the phase I/II or this study when patients receive recommended dose
- Patients who suffer Grade >=2 peripheral neuropathy or Grade >=2 neuropathic pain
- Patient has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, acute ischemia or active conduction system abnormalities.
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 |
|---|---|---|
| bortezomib | Drug | – |
Primary outcome
No. of patients who had adverse events, incidence and severity of adverse events, and relationship to the study drug. Overall response rate (Complete Remission + Partial Remission). Response will be evaluated by independent review committee.
1 secondary outcome
TTP (Time To Progression), survival time, time to response and duration of response. For re-treatment patients, survival time from the previous study drug treatment and response rate from the start of re-treatment will be also evaluated.
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 17 May 2011.
- A Continuous Administration or Readministration Study JNJ-26866138 (bortezomib) in Patients with Relapsed or Refractory Multiple MyelomaLink provided by the sponsor.
Related trials for Multiple Myeloma
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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.
Janssen Pharmaceutical K.K. Clinical Trial study director
Janssen Pharmaceutical K.K.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bortezomib in people with 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 4 inclusion and 5 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 phase mean?
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?
No. of patients who had adverse events, incidence and severity of adverse events, and relationship to the study drug. Overall response rate (Complete Remission + Partial Remission). Response will be evaluated by independent review committee.. 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 17 May 2011.