Multiple MyelomaPhase 4NCT00257114
Evaluation of VELCADE Given as Retreatment to Multiple Myeloma Patients for Efficacy, Safety and Tolerability
A Phase 4 study testing bortezomib in people with Multiple Myeloma, run by Millennium Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
Multiple myeloma represents the second most common hematological malignancy.VELCADE is a small molecule to treat human malignancies. Its anti-neoplastic effect invovles several distinct mechanisms including inhibition of cell growth. 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
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento Mar 2007
- Phase
- Phase 4
- 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
- Voluntary written informed consent with the understanding that the consent may be w/d by the patient at any time w/o prejudice to future medical care.
- Patient previously diagnosed with Multiple Myeloma (MM).
- Patient previously tolerated 0.7, 1.0, or 1.3 mg/m2/dose of VELCADE alone or therapy combination and had at least a greater/equal 50% reduction in M-Protein upon completion of VELCADE therapy. The DOR prior to VELCADE greater/equal 4 months for the patient population.
- It has been greater/equal 2 months since the patient's last VELCADE dose and the patient meets certain Lab criteria as per protocol.
- Patient has a Karnosfsky performance status greater/equal 60%.
- Patient has a life-expectancy greater than 3 months.
- Patient has laboratory values (defined in protocol) within 14 days before enrollment.
Who cannot join
- Patients with a Hx of PD, minimal response, or stable disease (SD)on first exposure to VELCADE.
- Patient has received chemotherapy, radiotherapy, immunotherapy or experimental therapy to treat multiple myeloma since their last dose of VELCADE.
- Patients who achieved a CR or PR but relapsed while on therapy.
- Patient had major surgery w/in 2 wks before enrollment.
- Patient has a Hx of allergic reaction to compounds containing boron or mannitol.
- Patient has peripheral sensory neuropathy of Grade 2 w/pain or greater intensity.
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- Patient has cardiac amyloidosis.
- Patient has poorly controlled hypertension, diabetes mellitus, or other serious medical or pysychiatric illness.
- Patient is known to be human immunodeficiency virus (HIV)+.
- Patient is known to be hepatitis B surface antigen-positive or has known active hepatitis C infection.
- Patient has an active systemic infection requiring treatment.
- Female patient is pregnant or breast-feeding. Confirmation must be established by a negative serum B-hCG.
- Patient is currently enrolled in another clinical research study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
About this study
Official title: Evaluation of VELCADE (Botezomib) for Injection Employed as Re-Treatment for Efficacy, Safety, and Tolerability
Multiple myeloma represents the second most common hematological malignancy.VELCADE is a small molecule to treat human malignancies. Its anti-neoplastic effect invovles several distinct mechanisms including inhibition of cell growth. Patients who have relapsed or are refractory to therapy, the standard of care is now VELCADE based on the results of previous clinical trials.
- Conditions
- Multiple Myeloma
- Being tested
- bortezomib
- Keywords
- Multiple Myeloma, Retreatment, VELCADE
- 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2005 (estimated)
- Primary completionMar 2007
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ian Walters, M.D., Study director, Millennium Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00257114
- Sponsor's protocol ID
- C05004
- Status last verified
- Feb 2008
- First submitted
- 18 Nov 2005
- Last updated
- 11 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of VELCADE (Botezomib) for Injection Employed as Re-Treatment for Efficacy, Safety, and Tolerability
- ClinicalTrials.gov ID
- NCT00257114
- Acronym / sponsor ID
- C05004
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Retreatment, VELCADE
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Primary completion
- Mar 2007 (actual)
- First posted
- 22 Nov 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.
Multiple myeloma represents the second most common hematological malignancy.VELCADE is a small molecule to treat human malignancies. Its anti-neoplastic effect invovles several distinct mechanisms including inhibition of cell growth. Patients who have relapsed or are refractory to therapy, the standard of care is now VELCADE based on the results of previous clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntary written informed consent with the understanding that the consent may be w/d by the patient at any time w/o prejudice to future medical care.
- Patient previously diagnosed with Multiple Myeloma (MM).
- Patient previously tolerated 0.7, 1.0, or 1.3 mg/m2/dose of VELCADE alone or therapy combination and had at least a greater/equal 50% reduction in M-Protein upon completion of VELCADE therapy. The DOR prior to VELCADE greater/equal 4 months for the patient population.
- It has been greater/equal 2 months since the patient's last VELCADE dose and the patient meets certain Lab criteria as per protocol.
- Patient has a Karnosfsky performance status greater/equal 60%.
Key exclusion criteria (13 listed)
- Patients with a Hx of PD, minimal response, or stable disease (SD)on first exposure to VELCADE.
- Patient has received chemotherapy, radiotherapy, immunotherapy or experimental therapy to treat multiple myeloma since their last dose of VELCADE.
- Patients who achieved a CR or PR but relapsed while on therapy.
- Patient had major surgery w/in 2 wks before enrollment.
- Patient has a Hx of allergic reaction to compounds containing boron or mannitol.
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
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 11 Feb 2008.
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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.
Ian Walters, M.D. study director
Millennium Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bortezomib in people with Multiple Myeloma, run by Millennium Pharmaceuticals, Inc. at 1 site in United States.
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 7 inclusion and 13 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 11 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.
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 11 Feb 2008.