Multiple MyelomaPhase 2NCT00504634
Bortezomib (Velcade) Post Allogenic Peripheral Blood Stem Cell Transplantation for Myeloma
A Phase 2 study testing Bortezomib in people with Multiple Myeloma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objective: 1. To determine the antimyeloma effect of bortezomib after allogeneic transplantation for patients with multiple myeloma. Secondary Objective 1. To determine the toxicity profile of bortezomib in patients with multiple myeloma undergoing allogeneic progenitor cell transplantation. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Bortezomib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to May 2010
- 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 Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with multiple myeloma at least 3 months post allogeneic transplant who either failed to achieve a complete remission or are relapsing.
- Allograft performed from a related donor who is HLA-compatible (5/6 or 6/6), or class I serologic match and class II molecular matched unrelated donor).
- Zubrod Points Scale (PS) < 2, life expectancy is not severely limited by concomitant illness.
- Patient willing and able to sign informed consent.
- Patients less than 70 years of age.
Who cannot join
- Active Central Nervous System (CNS) disease.
- Uncontrolled acute or chronic Graft-versus-host disease (GVHD).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Trial of Bortezomib (Velcade) After Allogenic Peripheral Blood Stem Cell or Bone Marrow Transplantation for Patients With Multiple Myeloma
Primary Objective:
- To determine the antimyeloma effect of bortezomib after allogeneic transplantation for patients with multiple myeloma.
Secondary Objective
- To determine the toxicity profile of bortezomib in patients with multiple myeloma undergoing allogeneic progenitor cell transplantation.
Read the detailed description
Bortezomib (velcade) is a new drug that works by blocking a structure in the cells called proteasome. This proteasome acts like a system that eliminates abnormal or old proteins from the cells. Cancer cells may be sensitive to drugs like bortezomib (velcade), because tumor cells have more abnormal proteins than normal cells. Bortezomib (velcade) enters the tumor cells and affects the way they divide. When cancer cells cannot divide, they die.
You will have blood (about 2 tablespoons) and bone marrow testing done about every 2-3 months to determine your response and tolerance to treatment. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle.
You will receive bortezomib (velcade) as an infusion into a vein over 5-10 minutes twice a week for 2 weeks. You will then rest for 10 to 17 days. This 21-28 day period makes up 1 cycle. You will complete up to a total of 4 cycles. Courses 2 and 3 might be given under supervision of your local physician however the principal investigator will do necessary treatment dose adjustments and new set of treatment orders will be provided to your physician. Treatment evaluations will be under the supervision of the principal investigator.
You will have a physical exam and routine blood tests (about 2 tablespoons) before each dose of bortezomib (velcade). Blood (about 2 tablespoons) and urine tests to determine response to treatment will be performed once a month, as well as blood tests to look at side effects of treatment, will be performed at least once a week and more frequently if medically necessary.
You will be taken off study if the disease gets worse or intolerable side effects occur. You will be called every 3 months for at least 1 year after the last dose of bortezomib (velcade) to see how you are doing.
This is an investigational study. Bortezomib (velcade) is commercially available and indicated for the treatment of myeloma. A total of 28 patients will participate in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Multiple Myeloma
- Being tested
- Bortezomib
- Keywords
- Multiple Myeloma, Post Allogeneic Transplantation, Bortezomib, Velcade, PS-341
- 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
Also called Velcade, PS-341
1 mg/m^2 IV On Days 1, 4, 8, and 11.
| Study group | Role | What they receive |
|---|---|---|
| Bortezomib | Experimental | 1 mg/m^2 intravenous (IV) Days 1, 4, 8, and 11. Receives: Drug: Bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Complete Response (CR)
Response rate (CR), evaluated within 6 weeks of beginning treatment, assessed using The European Group for Blood and Bone Marrow Transplant/International Bone Marrow Transplant Registry (EBMT/IBMTR) response criteria of Complete Response (CR), Minimal Response (MR), No Change (NC), or Progressive Disease (PD).
Measured: 6 weeks from beginning treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2007 (estimated)
- Study startJan 2004
- Primary completionAug 2007
- Study completionMay 2010
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 M.D. Anderson Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sergio A. Giralt, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504634
- Sponsor's protocol ID
- 2003-0751
- Status last verified
- Sep 2011
- First submitted
- 18 Jul 2007
- Last updated
- 15 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Bortezomib (Velcade) After Allogenic Peripheral Blood Stem Cell or Bone Marrow Transplantation for Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00504634
- Acronym / sponsor ID
- 2003-0751
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Post Allogeneic Transplantation, Bortezomib, Velcade, PS-341
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Aug 2007 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 20 Jul 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.
Primary Objective:
- To determine the antimyeloma effect of bortezomib after allogeneic transplantation for patients with multiple myeloma.
Secondary Objective
- To determine the toxicity profile of bortezomib in patients with multiple myeloma undergoing allogeneic progenitor cell transplantation.
Detailed description
Bortezomib (velcade) is a new drug that works by blocking a structure in the cells called proteasome. This proteasome acts like a system that eliminates abnormal or old proteins from the cells. Cancer cells may be sensitive to drugs like bortezomib (velcade), because tumor cells have more abnormal proteins than normal cells. Bortezomib (velcade) enters the tumor cells and affects the way they divide. When cancer cells cannot divide, they die.
You will have blood (about 2 tablespoons) and bone marrow testing done about every 2-3 months to determine your response and tolerance to treatment. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle.
You will receive bortezomib (velcade) as an infusion into a vein over 5-10 minutes twice a week for 2 weeks. You will then rest for 10 to 17 days. This 21-28 day period makes up 1 cycle. You will complete up to a total of 4 cycles. Courses 2 and 3 might be given under supervision of your local physician however the principal investigator will do necessary treatment dose adjustments and new set of treatment orders will be provided to your physician. Treatment evaluations will be under the supervision of the principal investigator.
You will have a physical exam and routine blood tests (about 2 tablespoons) before each dose of bortezomib (velcade). Blood (about 2 tablespoons) and urine tests to determine response to treatment will be performed once a month, as well as blood tests to look at side effects of treatment, will be performed at least once a week and more frequently if medically necessary.
You will be taken off study if the disease gets worse or intolerable side effects occur. You will be called every 3 months for at least 1 year after the last dose of bortezomib (velcade) to see how you are doing.
This is an investigational study. Bortezomib (velcade) is commercially available and indicated for the treatment of myeloma. A total of 28 patients will participate in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bortezomib | Experimental | Drug: Bortezomib1 mg/m^2 intravenous (IV) Days 1, 4, 8, and 11. |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with multiple myeloma at least 3 months post allogeneic transplant who either failed to achieve a complete remission or are relapsing.
- Allograft performed from a related donor who is HLA-compatible (5/6 or 6/6), or class I serologic match and class II molecular matched unrelated donor).
- Zubrod Points Scale (PS) < 2, life expectancy is not severely limited by concomitant illness.
- Patient willing and able to sign informed consent.
- Patients less than 70 years of age.
Key exclusion criteria (2 listed)
- Active Central Nervous System (CNS) disease.
- Uncontrolled acute or chronic Graft-versus-host disease (GVHD).
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 |
|---|---|---|
| BortezomibAlso: Velcade, PS-3411 mg/m^2 IV On Days 1, 4, 8, and 11. | Drug | Bortezomib |
Primary outcome
Number of Participants with Complete Response (CR)
Time frame: 6 weeks from beginning treatment
Response rate (CR), evaluated within 6 weeks of beginning treatment, assessed using The European Group for Blood and Bone Marrow Transplant/International Bone Marrow Transplant Registry (EBMT/IBMTR) response criteria of Complete Response (CR), Minimal Response (MR), No Change (NC), or Progressive Disease (PD).
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 15 Sep 2011.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Sergio A. Giralt, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bortezomib in people with Multiple Myeloma, run by M.D. Anderson Cancer Center 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 5 inclusion and 2 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 15 Sep 2011. 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 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?
Number of Participants with Complete Response (CR) (time frame: 6 weeks from beginning treatment). 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 15 Sep 2011.