Multiple MyelomaNCT00440635
Expanded Access Protocol (EAP) to Provide Bortezomib to Patients With Multiple Myeloma Who Have Received at Least 2 Previous Lines of Therapy and Are Refractory to or Have Relapsed After Their Last Therapy for Multiple Myeloma
An observational study of Multiple Myeloma, run by Janssen-Cilag International NV.
Trial summary
The purpose of this study is to provide bortezomib to patients with multiple myeloma who have received at least 2 previous lines of therapy and are refractory or have relapse after their last treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Bortezomib, tradename Velcade
- How many people
- 641 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Oct 2006
- Phase
- Observational
- 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 previous diagnosis of multiple myeloma based on standard criteria
- patient has received at least 2 previous lines of therapy for multiple myeloma and, currently requires therapy because of relapsed or progressive disease
- If female, the patient is either postmenopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide, or abstinence) from Screening through the Final Visit
- If male, the patient agrees to use an acceptable barrier method for contraception from Screening through the Final Visit
- patient has a Karnofsky performance status >= 60
- patient meets defined pretreatment laboratory criteria
Who cannot join
- If patient received bortezomib in a previous clinical trial, the patient's best response to bortezomib was progressive disease
- Patient received nitrosoureas within 6 weeks or any other chemotherapy within 3 weeks before enrollment, corticosteroids (>10 mg/day prednisone or equivalent) within 3 weeks before enrollment, immunotherapy or antibody therapy within 4 weeks before enrollment
- Patient has peripheral neuropathy of Grade 2 or greater intensity, as defined by the NCI CTC
- Patient had a myocardial infarction within 6 months of enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- Patient has cardiac amyloidosis
About this study
Official title: International Single-Arm Protocol to Provide Expanded Access to Bortezomib for Patients With Multiple Myeloma Who Have Received at Least 2 Previous Lines of Therapy and Are Refractory to or Have Relapsed After Their Last Therapy for Multiple Myeloma
The purpose of this study is to provide bortezomib to patients with multiple myeloma who have received at least 2 previous lines of therapy and are refractory or have relapse after their last treatment. Additional objectives of this study are assess the safety and tolerability of bortezomib and follow the levels of paraprotein in patients receiving bortezomib as a way to followup disease burden
Read the detailed description
Multiple myeloma is uniformly fatal. Responses achieved after multiple lines of therapy are normally of short duration. Therefore, all patients with multiple myeloma will eventually relapse, having become refractory to therapy and subsequently will die of their cancer. The rationale of this study is that bortezomib as a novel agent may allow additional periods of response due to its different mechanisms of action. This is an open-label, single-arm, multicenter, non-comparative study to provide expanded access to bortezomib to patients with multiple myeloma that have received at least two previous lines of therapy and are refractory to or have relapsed after their last treatment. Patients will receive treatment with bortezomib 1.3 mg/m2 on day 1, 4, 8 and 11 of a 3-week cycle. No treatment will be administered on the last 10 days of each cycle. Treatment may be repeated for up to 8 cycles with possible extension if patient is still responding at the end of the 8 cycle period. Bortezomib 1.3 mg/m2 will be administered as an IV bolus
- Conditions
- Multiple Myeloma
- Being tested
- Bortezomib, tradename Velcade
- Keywords
- Multiple myeloma, bortezomib, Hematology
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bortezomib, tradename VelcadeDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2007 (estimated)
- Study startJan 2004
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 641 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag International NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen-Cilag International NV Clinical Trial, Study director, Janssen-Cilag International NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00440635
- Sponsor's protocol ID
- CR002185
- Status last verified
- Apr 2013
- First submitted
- 26 Feb 2007
- Last updated
- 16 Apr 2013
- Results posted
- No
Publications
Quach H, Horvath N, Cannell P, Mikhael JR, Butcher BE, Prince HM. Safety and efficacy results from an international expanded access programme to bortezomib for patients with relapsed and/or refractory multiple myeloma: a subset analysis of the Australian and New Zealand data of 111 patients. Intern Med J. 2009 May;39(5):290-5. doi: 10.1111/j.1445-5994.2008.01738.x. Epub 2008 Jun 28.
PubMed 19371392
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Single-Arm Protocol to Provide Expanded Access to Bortezomib for Patients With Multiple Myeloma Who Have Received at Least 2 Previous Lines of Therapy and Are Refractory to or Have Relapsed After Their Last Therapy for Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00440635
- Acronym / sponsor ID
- CR002185
- Conditions
- Multiple Myeloma
- Keywords
- Multiple myeloma, bortezomib, Hematology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 641 participants (actual)
- Lead sponsor
- Janssen-Cilag International NVIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Study completion
- Oct 2006 (actual)
- First posted
- 27 Feb 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 purpose of this study is to provide bortezomib to patients with multiple myeloma who have received at least 2 previous lines of therapy and are refractory or have relapse after their last treatment. Additional objectives of this study are assess the safety and tolerability of bortezomib and follow the levels of paraprotein in patients receiving bortezomib as a way to followup disease burden
Detailed description
Multiple myeloma is uniformly fatal. Responses achieved after multiple lines of therapy are normally of short duration. Therefore, all patients with multiple myeloma will eventually relapse, having become refractory to therapy and subsequently will die of their cancer. The rationale of this study is that bortezomib as a novel agent may allow additional periods of response due to its different mechanisms of action. This is an open-label, single-arm, multicenter, non-comparative study to provide expanded access to bortezomib to patients with multiple myeloma that have received at least two previous lines of therapy and are refractory to or have relapsed after their last treatment. Patients will receive treatment with bortezomib 1.3 mg/m2 on day 1, 4, 8 and 11 of a 3-week cycle. No treatment will be administered on the last 10 days of each cycle. Treatment may be repeated for up to 8 cycles with possible extension if patient is still responding at the end of the 8 cycle period. Bortezomib 1.3 mg/m2 will be administered as an IV bolus
Study design
- Time perspective
- Prospective
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 previous diagnosis of multiple myeloma based on standard criteria
- patient has received at least 2 previous lines of therapy for multiple myeloma and, currently requires therapy because of relapsed or progressive disease
- If female, the patient is either postmenopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide, or abstinence) from Screening through the Final Visit
- If male, the patient agrees to use an acceptable barrier method for contraception from Screening through the Final Visit
- patient has a Karnofsky performance status >= 60
Key exclusion criteria (5 listed)
- If patient received bortezomib in a previous clinical trial, the patient's best response to bortezomib was progressive disease
- Patient received nitrosoureas within 6 weeks or any other chemotherapy within 3 weeks before enrollment, corticosteroids (>10 mg/day prednisone or equivalent) within 3 weeks before enrollment, immunotherapy or antibody therapy within 4 weeks before enrollment
- Patient has peripheral neuropathy of Grade 2 or greater intensity, as defined by the NCI CTC
- Patient had a myocardial infarction within 6 months of enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- Patient has cardiac amyloidosis
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, tradename Velcade | Drug | – |
Primary outcome
Not reported in the source record.
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 16 Apr 2013.
- Derived from this study: PubMed 19371392Quach H, Horvath N, Cannell P, Mikhael JR, Butcher BE, Prince HM. Safety and efficacy results from an international expanded access programme to bortezomib for patients with relapsed and/or refractory multiple myeloma: a subset analysis of the Australian and New Zealand data of 111 patients. Intern Med J. 2009 May;39(5):290-5. doi: 10.1111/j.1445-5994.2008.01738.x. Epub 2008 Jun 28.
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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-Cilag International NV Clinical Trial study director
Janssen-Cilag International NV
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Janssen-Cilag International NV.
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 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 16 Apr 2013. 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00440635, which also lists 1 linked publication.
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 16 Apr 2013.