Multiple MyelomaPhase 2NCT01090921
Safety and Efficacy Study of Single Weekly Bortezomib in Newly Diagnosed Multiple Myeloma
A Phase 2 study testing Bortezomib in people with Multiple Myeloma, run by Boston VA Research Institute, Inc. at 11 sites in United States.
Trial summary
This is a research study to see if a new drug called bortezomib is useful to treat multiple myeloma in people who are newly diagnosed, and have not yet received treatment for their disease. VELCADE® (bortezomib) for Injection is a drug under development by Millennium Pharmaceuticals, Inc. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 11 sitesUnited States
- Study dates
- May 2007to Mar 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diagnosis of multiple myeloma based on standard criteria.
- Measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis of > 1Gm/dL and/or urine monoclonal immunoglobulin spike of > 200mg/24 hours.
- Non-secretors must have measurable protein by Freelite or measurable disease such as plasmacytoma to be eligible.
- Patient must not have been previously treated with chemotherapy. Prior treatment of hypercalcemia with corticosteroids, or bisphosphonates does not disqualify the patient.
- Patient must be ineligible for autologous stem cell transplant due to one or more of the following reasons:
- Age>65
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- Impaired renal function (creatinine≥2.0 mg/dL)
- Impaired pulmonary function (DLCO≤50%)
- Poor performance status (KPS≤80)
- Other prohibitive comorbid disorder
- 5b. Patients≥60 who decline autologous stem cell transplant are eligible for this study.
- 5c. Patients who are eligible but wish to postpone autologous stem cell transplant are eligible for this study.
- Karnofsky performance status>50
- Patients treated with local radiotherapy with or without a brief exposure to steroids are eligible. Patients who require concurrent radiotherapy should have entry to the protocol deferred until the radiotherapy is completed, followed by a four week wash out period Spot RT to ≤3 vertebrae acceptable prior to entry.
- Meets the following pretreatment laboratory criteria at Baseline (Within 14 days prior to study drug administration):
- Platelet count>50x10^9/L or, if the bone marrow is extensively infiltrated,>30x10^9/L
- Hemoglobin>8.0G/dL
- Absolute neutrophil count >1.0x10^9/L or, if the bone marrow is extensively infiltrated, >0.5x10^9/L
- Meets the following pretreatment laboratory criteria for liver function tests at the screening visit conducted within 14 days of registration
- AST (SGOT): <3 times the upper limit of institutional laboratory normal
- ALT (SGPT): <3 times the upper limit of institutional laboratory normal
- Total bilirubin: <2 times the upper limit of institutional laboratory normal, unless clearly related to the disease
- Women with child-bearing potential should be practicing an adequate form of contraception, as judged by the investigator (i.e. birth control pills, double barrier method, abstinence, etc.) or be surgically sterile or 12 months post-menopausal. Male subject agrees to use an acceptable method for contraception for the duration of the study.
- Age 18 years or older
- Has given voluntary written informed consent.
Who cannot join
- POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes)
- Plasma cell leukemia
- Impaired kidney function requiring dialysis, patients on hemodialysis are excluded
- Receiving steroids >the equivalent of 10mg prednisone daily for other medical conditions, e.g., asthma, systemic lupus erythematosis, rheumatoid arthritis
- Infection not controlled by antibiotics
- HIV infection. Patients should provide consent for HIV testing according to the institution's standard practice
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- Known active hepatitis B or C
- Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (Appendix D), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- Second malignancy requiring concurrent treatment
- Other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
- Positive pregnancy test in women of childbearing potential
- Patient has hypersensitivity to boron or mannitol.
- Patient has ≥Grade 2 peripheral neuropathy within 14 days before enrollment.
- Patient has received other investigational drugs with 14 days before enrollment
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Atlanta VA Medical Center
Atlanta, Georgia, 30033
Eastern Colorado Health Care System
Denver, Colorado, 80220
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
VA Boston Healthcare System
Jamaica Plain, Massachusetts, 02130
Kansas City VA Medical Center
Kansas City, Missouri, 64128
Little Rock VA Medical Center
Little Rock, Arkansas, 72205
West Los Angeles VA Medical Center
Los Angeles, California, 90073
Pittsburgh VA Medical Center
Pittsburgh, Pennsylvania, 15240
San Francisco VA Medical Center
San Francisco, California, 94121
Tampa VA Medical Center
Tampa, Florida, 33612
West Haven VA Medical Center
West Haven, Connecticut, 06516
About this study
Official title: Phase II Study to Evaluate Efficacy and Safety of Single Weekly Administration of Bortezomib in Newly Diagnosed Multiple Myeloma
This is a research study to see if a new drug called bortezomib is useful to treat multiple myeloma in people who are newly diagnosed, and have not yet received treatment for their disease. VELCADE® (bortezomib) for Injection is a drug under development by Millennium Pharmaceuticals, Inc.
Read the detailed description
This study is a multi-site study which will enroll up to 50 patients with multiple myeloma who have not had prior treatment.
Prior to starting treatment individuals will be evaluated to determine if they are eligible to participate in the study. There are certain prestudy test that are required: physical exam, blood tests, ECG, chest x-ray, skeletal survey, bone marrow aspirate and biopsy to confirm the diagnosis of multiple myeloma and to determine baseline health status.
Before beginning each treatment cycle and at the end of the study, patients will have protein studies (including blood and urine) to see if they are responding to the treatment. Before each weekly treatment cycle patients will also have blood tests for red and white blood cells and platelets, and blood chemistry tests for electrolytes, kidney and liver function, calcium and blood sugar.
Patients may receive up to 6 cycles of treatment. At the end of the study, individuals who have responded to treatment will be seen every two months to check for disease progression.
- Conditions
- Multiple Myeloma
- Being tested
- Bortezomib
- Keywords
- Multiple Myeloma, Bortezomib, Newly diagnosed, Newly diagnosed Multiple Myeloma
- 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
Bortezomib will be administered at a dose of 1.6 mg/m2 IV push. Treatment will be administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle.
Dexamethasone will also be administered at a dose of 40mg on the day of and day after each dose of bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone.
| Study group | Role | What they receive |
|---|---|---|
| Single-Arm | Experimental | Bortezomib is administered at a dose of 1.6mg/m2 IV push over 3 to 5 seconds. Treatment is administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle. Dexamethasone is also administered at a dose of 40mg daily on day of and day after each dose of Bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone. The study duration for a given subject will be approximately 30 weeks. Receives: Drug: Bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants at Each Response Category (Stable Disease, Minimal Response, Partial Response, Very Good Partial Response, Near Complete Response/Complete Resonse)
To evaluate the response rate for weekly administered bortezomib + dexamethasone in patients with newly diagnosed multiple myeloma who are ineligible for transplant or who are eligible but wish to postpone autologous stem cell transplant.
Measured: Data was collected for each subject for the duration of the participation in the study, which was an average of 4.8 cycles.
Secondary outcomes (1)
Number of Participants With Dose Reductions in Bortezomib, Dexamethasone or Both
To evaluate the toxicity (safety and tolerability) of weekly bortezomib + dexamethasone in patients with newly diagnosed multiple myeloma who are ineligible for transplant or who are eligible but wish to postpone autologous stem cell transplant.
Measured: Data was collected for each subject for the duration of the participation in the study, which was an average of 4.8 cycles.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2010 (estimated)
- Study startMay 2007
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston VA Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Responsible party
- Principal investigator, Nikhil Munshi, M.D., Boston VA Research Institute, Inc.
- Investigators
- Nikhil C. Munshi, M.D., Principal investigator, Boston VA Research Institute, Inc.Saem Lee, Study chair, Boston VA Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090921
- Sponsor's protocol ID
- X05153
- Status last verified
- Aug 2020
- First submitted
- 15 Mar 2010
- Last updated
- 9 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Girnius SK, Lee S, Kambhampati S, Rose MG, Mohiuddin A, Houranieh A, Zimelman A, Grady T, Mehta P, Behler C, Hayes TG, Efebera YA, Prabhala RH, Han A, Yellapragada SV, Klein CE, Roodman GD, Lichtenstein A, Munshi NC. A Phase II trial of weekly bortezomib and dexamethasone in veterans with newly diagnosed multiple myeloma not eligible for or who deferred autologous stem cell transplantation. Br J Haematol. 2015 Apr;169(1):36-43. doi: 10.1111/bjh.13243. Epub 2015 Jan 8.
PubMed 25572917
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Evaluate Efficacy and Safety of Single Weekly Administration of Bortezomib in Newly Diagnosed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01090921
- Acronym / sponsor ID
- X05153
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Bortezomib, Newly diagnosed, Newly diagnosed Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Boston VA Research Institute, Inc.University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Study start
- May 2007
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 23 Mar 2010 (estimated)
- Results
- Posted 20 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a research study to see if a new drug called bortezomib is useful to treat multiple myeloma in people who are newly diagnosed, and have not yet received treatment for their disease. VELCADE® (bortezomib) for Injection is a drug under development by Millennium Pharmaceuticals, Inc.
Detailed description
This study is a multi-site study which will enroll up to 50 patients with multiple myeloma who have not had prior treatment.
Prior to starting treatment individuals will be evaluated to determine if they are eligible to participate in the study. There are certain prestudy test that are required: physical exam, blood tests, ECG, chest x-ray, skeletal survey, bone marrow aspirate and biopsy to confirm the diagnosis of multiple myeloma and to determine baseline health status.
Before beginning each treatment cycle and at the end of the study, patients will have protein studies (including blood and urine) to see if they are responding to the treatment. Before each weekly treatment cycle patients will also have blood tests for red and white blood cells and platelets, and blood chemistry tests for electrolytes, kidney and liver function, calcium and blood sugar.
Patients may receive up to 6 cycles of treatment. At the end of the study, individuals who have responded to treatment will be seen every two months to check for disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-Arm | Experimental | Drug: BortezomibBortezomib is administered at a dose of 1.6mg/m2 IV push over 3 to 5 seconds. Treatment is administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle. Dexamethasone is also administered at a dose of 40mg daily on day of and day after each dose of Bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone. The study duration for a given subject will be approximately 30 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Diagnosis of multiple myeloma based on standard criteria.
- Measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis of > 1Gm/dL and/or urine monoclonal immunoglobulin spike of > 200mg/24 hours.
- Non-secretors must have measurable protein by Freelite or measurable disease such as plasmacytoma to be eligible.
- Patient must not have been previously treated with chemotherapy. Prior treatment of hypercalcemia with corticosteroids, or bisphosphonates does not disqualify the patient.
- Patient must be ineligible for autologous stem cell transplant due to one or more of the following reasons:
Key exclusion criteria (14 listed)
- POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes)
- Plasma cell leukemia
- Impaired kidney function requiring dialysis, patients on hemodialysis are excluded
- Receiving steroids >the equivalent of 10mg prednisone daily for other medical conditions, e.g., asthma, systemic lupus erythematosis, rheumatoid arthritis
- Infection not controlled by antibiotics
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: VelcadeBortezomib will be administered at a dose of 1.6 mg/m2 IV push. Treatment will be administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle. Dexamethasone will also be administered at a dose of 40mg on the day of and day after each dose of bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone. | Drug | Single-Arm |
Primary outcome
Number of Participants at Each Response Category (Stable Disease, Minimal Response, Partial Response, Very Good Partial Response, Near Complete Response/Complete Resonse)
Time frame: Data was collected for each subject for the duration of the participation in the study, which was an average of 4.8 cycles.
To evaluate the response rate for weekly administered bortezomib + dexamethasone in patients with newly diagnosed multiple myeloma who are ineligible for transplant or who are eligible but wish to postpone autologous stem cell transplant.
1 secondary outcome
Number of Participants With Dose Reductions in Bortezomib, Dexamethasone or Both
Time frame: Data was collected for each subject for the duration of the participation in the study, which was an average of 4.8 cycles.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25572917Girnius SK, Lee S, Kambhampati S, Rose MG, Mohiuddin A, Houranieh A, Zimelman A, Grady T, Mehta P, Behler C, Hayes TG, Efebera YA, Prabhala RH, Han A, Yellapragada SV, Klein CE, Roodman GD, Lichtenstein A, Munshi NC. A Phase II trial of weekly bortezomib and dexamethasone in veterans with newly diagnosed multiple myeloma not eligible for or who deferred autologous stem cell transplantation. Br J Haematol. 2015 Apr;169(1):36-43. doi: 10.1111/bjh.13243. Epub 2015 Jan 8.
- Individual participant dataSharing planned: No
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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.
Nikhil C. Munshi, M.D. principal investigator
Boston VA Research Institute, Inc.
Saem Lee study chair
Boston VA Research Institute, Inc.
11 sites 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 Boston VA Research Institute, Inc. at 11 sites 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 25 inclusion and 14 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 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
Yes. Results are posted in the registry (first posted 20 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 at Each Response Category (Stable Disease, Minimal Response, Partial Response, Very Good Partial Response, Near Complete Response/Complete Resonse) (time frame: Data was collected for each subject for the duration of the participation in the study, which was an average of 4.8 cycles.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01090921, 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 9 Sep 2020.