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Proteasome Inhibitor
Bortezomib + Dexamethasone for Multiple Myeloma
Phase 2
Waitlist Available
Research Sponsored by Sparrow Regional Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of multiple myeloma
Refractory or relapsed disease meeting the specified criteria: primary refractory disease and first-line relapsing disease, or progressive disease after last therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying bortezomib and dexamethasone to see how well they work in treating patients with relapsed or refractory multiple myeloma.
Who is the study for?
This trial is for adults with multiple myeloma that hasn't improved or has come back after treatment. They should be relatively healthy, able to perform daily activities (ECOG 0-2), and have a life expectancy over 3 months. Participants need normal kidney function, no severe neuropathy, controlled heart conditions, not HIV positive, and can't be on other clinical trials or certain treatments recently.Check my eligibility
What is being tested?
The study tests the combination of Bortezomib and Dexamethasone in patients whose multiple myeloma has relapsed or is resistant to initial therapy. It aims to see if this combo can effectively kill cancer cells by blocking their growth enzymes and blood supply.See study design
What are the potential side effects?
Possible side effects include nerve damage (neuropathy), low blood counts leading to increased bleeding risk or infections, fatigue, nausea, vomiting, diarrhea; as well as potential heart complications like irregular heartbeat.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with multiple myeloma.
Select...
My condition did not improve after initial treatment or it came back.
Select...
I can take care of myself and perform daily activities.
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
Overall response rate
Secondary outcome measures
Duration of response after completion of treatment
Overall and progression-free survival
Time to progression
+2 moreFind a Location
Who is running the clinical trial?
Sparrow Regional Cancer CenterLead Sponsor
Gordan Srkalovic, MD, PhDStudy ChairSparrow Regional Cancer Center
2 Previous Clinical Trials
7 Total Patients Enrolled
1 Trials studying Multiple Myeloma
7 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken chemotherapy drugs like clarithromycin in the last 4 weeks.I have not had radiotherapy in the last 3 weeks.You have taken any experimental drugs in the last two weeks.Your hemoglobin level is at least 7.5 grams per deciliter.You have to have a test that shows you are not pregnant.I have not undergone plasmapheresis in the last 4 weeks.Your blood calcium level is lower than 14 mg/dL.Your liver enzymes (AST and ALT) are not too high.Your kidneys are working well enough to clear out waste from your body.I am HIV positive.You are expected to live for at least 3 more months.I have had moderate to severe numbness, tingling, or pain in my hands or feet in the last 2 weeks.I haven't had any cancer treatments, except for basal cell skin cancer, in the last 5 years.My chronic conditions like diabetes or high blood pressure are not well-managed.I have previously been treated with bortezomib.I haven't taken more than 10 mg/day of steroids like prednisone in the last 3 weeks.I have been diagnosed with multiple myeloma.I have not had a heart attack or severe heart issues in the last 6 months.I am currently being treated for an infection.I do not have any serious health or mental conditions that would stop me from joining the study.My condition did not improve after initial treatment or it came back.I am allowed to receive blood transfusions.I have not received any immunotherapy in the last 8 weeks.I can take care of myself and perform daily activities.I have not had major surgery in the last 4 weeks.You have enough infection-fighting white blood cells in your body.You have an active hepatitis B or C infection.You are allergic to boron or mannitol.Your platelet count needs to be at least 50,000/mm³, or at least 30,000/mm³ if your bone marrow is significantly involved.
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.
What possible risks exist with this therapeutic approach?
"This treatment has been granted a score of 2, indicating some positive safety data but no efficacy evidence. This is the standard for Phase 2 trials."
Answered by AI
Are there still openings available in this clinical trial?
"According to clinicaltrials.gov, the trial is not presently recruiting patients and its last update was in 2014. Although this study is no longer enrolling candidates, 811 other medical trials are currently welcoming participants."
Answered by AI
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