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Proteasome Inhibitor
Combination Chemotherapy for Multiple Myeloma
Phase 2
Waitlist Available
Led By William I. Bensinger, MD
Research Sponsored by Fred Hutchinson Cancer Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Symptomatic disease requiring treatment
Diagnosis of multiple myeloma meeting specified criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying bortezomib in combination with cyclophosphamide, dexamethasone, and thalidomide to see how well it works in treating patients with newly diagnosed, previously untreated multiple myeloma.
Who is the study for?
This trial is for adults with newly diagnosed, untreated multiple myeloma. Participants must have a certain level of physical ability (Karnofsky score 50-100%), no HIV or active hepatitis, and not be pregnant or nursing. They should have adequate blood counts and organ function, agree to use two forms of contraception, and cannot have severe heart conditions, uncontrolled infections, other cancers needing treatment, or significant nerve damage.Check my eligibility
What is being tested?
The study tests the combination of bortezomib with cyclophosphamide, dexamethasone, and thalidomide in treating multiple myeloma. It aims to see if this drug mix can more effectively kill cancer cells by blocking their growth pathways and cutting off their blood supply.See study design
What are the potential side effects?
Potential side effects include nerve damage (neuropathy), low blood counts leading to increased infection risk or bleeding problems, liver issues reflected in enzyme changes, allergic reactions to the drugs used including mannitol present in some formulations; fatigue; digestive disturbances; muscle weakness; and potential heart complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition causes symptoms that need treatment.
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I have been diagnosed with multiple myeloma.
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My condition has been recently diagnosed and I haven't received any treatment yet.
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I can perform most of my daily activities without assistance.
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My kidneys work well enough that I don't need dialysis.
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I do not have active hepatitis B or C.
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I do not have another cancer that needs treatment at the same time.
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I do not have significant nerve damage.
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I do not have any infections that aren't responding to treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response rate
Secondary outcome measures
Safety and tolerability
Find a Location
Who is running the clinical trial?
Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,202 Total Patients Enrolled
64 Trials studying Multiple Myeloma
2,931 Patients Enrolled for Multiple Myeloma
Fred Hutchinson Cancer CenterLead Sponsor
556 Previous Clinical Trials
1,343,225 Total Patients Enrolled
66 Trials studying Multiple Myeloma
3,752 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,110 Total Patients Enrolled
578 Trials studying Multiple Myeloma
188,687 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have heart failure that affects my daily activities.I have a heart condition.I have received treatments like chemotherapy for my myeloma before.You have recently had a heart problem or have an active issue with your heart's electrical system.You have a disease that can be measured and observed.You must have a negative pregnancy test.You are currently receiving other chemotherapy or experimental medications.You must have a certain amount of platelets in your blood.You have never had an allergic reaction to medications containing mannitol, bortezomib, or cyclophosphamide.I have been diagnosed with plasma cell leukemia.I am taking more than 10 mg of prednisone daily for another health issue.I do not have any infections that aren't responding to treatment.I experience mild to severe numbness or pain in my hands or feet.You have enough infection-fighting white blood cells in your body.Your AST and ALT levels are not more than 2 times the upper limit of normal.Your bilirubin level is not more than 1.5 times the upper limit of normal, unless it is clearly caused by the disease being studied.Your kidneys work well enough to clear out waste products from your blood.I have been diagnosed with POEMS syndrome.My condition causes symptoms that need treatment.I have had a heart attack in the last 6 months.I have severe heart rhythm problems that aren't controlled.I have a serious heart lining condition.I am on dialysis due to kidney failure.I am being treated for another cancer besides the one being studied.I have chest pain that isn't managed by medication.I am allergic to mannitol, bortezomib, or cyclophosphamide.I have been diagnosed with multiple myeloma.My cancer has spread to other organs or tissues.My condition has been recently diagnosed and I haven't received any treatment yet.I can perform most of my daily activities without assistance.I am using two forms of birth control starting 4 weeks before, during, and 4 weeks after treatment.My kidneys work well enough that I don't need dialysis.I do not have active hepatitis B or C.I do not have another cancer that needs treatment at the same time.I do not have significant nerve damage.I do not have any infections that aren't responding to treatment.Your hemoglobin level is at least 8.5 grams per deciliter.You do not have HIV.You have HIV.You have a current, ongoing hepatitis B or C infection.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the FDA sanction this medication?
"While there is some data supporting the safety of this treatment, it received a score of 2 because Phase 2 trials have not yet yielded evidence of efficacy."
Answered by AI
How many different health centers are conducting this research project in Canada?
"The trial is based in several hospitals, including Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center in Los Angeles and Sutter Cancer Center in Sacramento. Additionally, there are numerous other locations across the states of Florida, New york and Oregon."
Answered by AI
Are there still places available in this clinical trial for people who want to participate?
"According to information found on clinicaltrials.gov, this study is not currently seeking patients for participation. The trial was originally posted on 8/1/2006 and updated for the last time on 3/12/2009; however, there are many other trials (831 in total) that are still recruiting patients."
Answered by AI
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