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Bisphosphonate

Combination Therapy for Bone Cancer

Phase 3
Waitlist Available
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men must use a latex condom during sexual contact with a female of childbearing potential
Radiation dose should range from 4500 cGy to 6000 cGy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 5 years
Awards & highlights

Study Summary

This trial is comparing two treatments for a type of bone cancer. One treatment is just radiation therapy, and the other is radiation therapy with drugs that may help kill cancer cells or reduce bone pain. It is not yet known which treatment is more effective.

Who is the study for?
Adults with solitary plasmacytoma of bone, measurable by specific protein levels or flow cytometry, who've had radiation therapy can join. They must have good organ function and no recent major surgery, untreated infections, or certain heart conditions. Pregnant women and those not using contraception are excluded.Check my eligibility
What is being tested?
The trial is testing if adding ixazomib citrate (which blocks cancer cell growth), lenalidomide (boosts immune system to kill cancer cells), dexamethasone (chemotherapy drug causing tumor cell death), and zoledronic acid (prevents fractures) after radiation is better than just zoledronic acid alone.See study design
What are the potential side effects?
Possible side effects include digestive issues, blood disorders, increased risk of infection due to immune system suppression from lenalidomide and dexamethasone; kidney problems from zoledronic acid; and potential nerve damage known as peripheral neuropathy from ixazomib.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I will use a latex condom during sex if my partner can have children.
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My radiation therapy dose was between 4500 and 6000 cGy.
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I am 18 years old or older.
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I can take care of myself and am up and about more than half of the day.
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My disease can be measured through blood or urine tests.
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I haven't received any treatment after radiation therapy.
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My cancer is confirmed as a single bone marrow tumor.
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I am not pregnant and use effective birth control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival rate
Secondary outcome measures
Changes in minimal residual disease from study entry to the completion of adjuvant treatment (approximately six months post-registration) and at 1 year post-registration
Clinical response rate at 12 months post-registration using whole body PET/CT

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ixazomib + lenalidomide + dexamethasone + zoledronic acidExperimental Treatment4 Interventions
Patients receive 4 mg ixazomib by mouth on days 1, 8 and 15. Patients also receive 15 mg lenalidomide by mouth on days 1-21, 12 mg dexamethasone by mouth on days 1, 8, 15, and 22 and zoledronic acid (dose based on creatinine clearance on day 1) IV infusion on day 1. Patients receive treatment every 28 days for a maximum of 6 cycles.
Group II: zoledronic acidActive Control1 Intervention
Patients receive zoledronic acid (dose based on creatinine clearance on day 1) IV on day 1. Patients receive treatment every 28 days for a maximum of 6 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ixazomib
FDA approved
Lenalidomide
FDA approved
Dexamethasone
FDA approved
Zoledronic acid
FDA approved

Find a Location

Who is running the clinical trial?

Millennium Pharmaceuticals, Inc.Industry Sponsor
404 Previous Clinical Trials
46,938 Total Patients Enrolled
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,623 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,635 Total Patients Enrolled

Media Library

Zoledronic Acid (Bisphosphonate) Clinical Trial Eligibility Overview. Trial Name: NCT02516423 — Phase 3
Osseous Plasmacytoma Research Study Groups: ixazomib + lenalidomide + dexamethasone + zoledronic acid, zoledronic acid
Osseous Plasmacytoma Clinical Trial 2023: Zoledronic Acid Highlights & Side Effects. Trial Name: NCT02516423 — Phase 3
Zoledronic Acid (Bisphosphonate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02516423 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other zoledronic acid research exists?

"zoledronic acid was first studied in 2002 by the Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. There have been a total of 1517 completed clinical trials to date. As of now, there are 784 live clinical trials, with many of these studies based in Princeton, Illinois."

Answered by AI

For what reasons is zoledronic acid commonly given to patients?

"Zoledronic acid can be used to effectively treat ophthalmia, sympathetic, and at least two prior systemic chemotherapy regimens, as well as branch retinal vein occlusion."

Answered by AI

Is zoledronic acid use associated with any health risks?

"Zoledronic acid has received a score of 3 from our team at Power. This is because it has progressed to Phase 3 clinical trials, which demonstrates some efficacy and multiple rounds of data supporting safety."

Answered by AI

If a patient meets the qualifications, can they still join the clinical trial?

"This study is not recruiting at the moment, but this may change in the future. According to the latest update on 8/16/2021, this trial was first posted on 12/1/2015. If you're interested in other studies, 40 trials for plasmacytoma and 784 for zoledronic acid are currently looking for participants."

Answered by AI

How many human participants are currently enrolled in this clinical trial?

"No, this particular clinical trial is not actively enrolling. The study was initially posted on December 1st, 2015 but was last edited on August 16th, 2021. If you are looking for other studies, 40 trials for plasmacytoma and 784 trials for zoledronic acid are still enrolling patients."

Answered by AI
~1 spots leftby Sep 2024