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Corticosteroid

Ibrutinib + Revlimid/Dexamethasone for Multiple Myeloma

Phase 1
Waitlist Available
Led By Suzanne George, MD
Research Sponsored by Alliance Foundation Trials, LLC.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 1 prior therapy with demonstrated disease progression following the most recent line of treatment
Progression of disease within 60 days of completion of last therapeutic regimen or failure to achieve minimal response while on last treatment
Must not have
Known infection with HIV, HCV, or HBV
Currently active, clinically significant hepatic impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 34 months
Awards & highlights

Summary

This trial is testing a combination of three drugs in patients whose multiple myeloma has returned or did not respond to previous treatments. The drugs work by blocking cancer cell growth, boosting the immune system, and reducing inflammation. The study aims to find the safest and most effective dose of these drugs.

Who is the study for?
This trial is for adults with relapsed/refractory multiple myeloma who have measurable disease, are in good physical condition (ECOG 0-1), and haven't progressed on high-dose lenalidomide. They must not have used ibrutinib or similar drugs before, be able to consent, follow the study plan, and provide samples for research. Pregnant women and those with certain health conditions are excluded.
What is being tested?
The study tests a combination of Ibrutinib with Lenalidomide/Dexamethasone in men and women who've had at least one prior therapy for multiple myeloma. It's an open-label phase 1 trial where all participants receive the drug combo to evaluate its safety and effectiveness.
What are the potential side effects?
Potential side effects include risk of bleeding, infections due to lowered immunity from Dexamethasone; heart issues or liver problems from Ibrutinib; and blood clots or kidney damage from Lenalidomide. Side effects vary by individual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition worsened after my last treatment.
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My condition worsened within 2 months after my last treatment.
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My blood counts are healthy without needing transfusions or medications to help.
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I am not pregnant.
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I am fully active or can carry out light work.
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I have symptoms from my multiple myeloma, which can be measured.
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My condition did not worsen while on lenalidomide doses over 10mg.
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I have not taken ibrutinib or drugs targeting B-cell signals.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an infection with HIV, HCV, or HBV.
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I have a serious liver condition that is affecting me now.
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I have a known bleeding disorder.
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I have not had major surgery in the last 4 weeks.
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My diabetes is not well-managed.
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I have a heart condition that affects my daily life.
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I have an ongoing infection that is not under control.
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I have lingering side effects from previous cancer treatments.
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I cannot swallow pills or have a major stomach condition.
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I do not have any severe illnesses or conditions that could threaten my life.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~34 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 34 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum Tolerated Dose for Combination
Objective Response Rate
Secondary study objectives
Duration of Response
Maximum Toxicity Grade
Overall Survival
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose ExpansionExperimental Treatment3 Interventions
Dosage of the combination will depend on the determine of maximum tolerated dose learned from the Dose Escalation phase. Dose Expansion (Ibrutinib, Lenalidomide, Dexamethasone Combination)
Group II: Dose EscalationExperimental Treatment3 Interventions
Dose escalation will consist of three different drug levels of Ibrutinib, Lenalidomide, and Dexamethasone. Dose Escalation (Ibrutinib, Lenalidomide, Dexamethasone Combination)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
2014
Completed Phase 4
~2060
Lenalidomide
2005
Completed Phase 3
~1340
Dexamethasone
2007
Completed Phase 4
~2650

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
BTK inhibitors, such as ibrutinib, block Bruton's tyrosine kinase, a key enzyme in the signaling pathways that promote the growth and survival of myeloma cells. Immunomodulatory drugs (IMiDs) like lenalidomide enhance the immune system's ability to attack myeloma cells, inhibit angiogenesis (formation of new blood vessels that supply the tumor), and directly induce myeloma cell death. Corticosteroids, such as dexamethasone, reduce inflammation and have direct anti-myeloma effects by inducing apoptosis (programmed cell death) in myeloma cells. These mechanisms are crucial for Multiple Myeloma patients as they target the disease through different pathways, improving treatment efficacy and potentially leading to better outcomes.

Find a Location

Who is running the clinical trial?

Pharmacyclics LLC.Industry Sponsor
113 Previous Clinical Trials
13,831 Total Patients Enrolled
7 Trials studying Multiple Myeloma
264 Patients Enrolled for Multiple Myeloma
Alliance Foundation Trials, LLC.Lead Sponsor
23 Previous Clinical Trials
25,000 Total Patients Enrolled
2 Trials studying Multiple Myeloma
79 Patients Enrolled for Multiple Myeloma
Suzanne George, MDPrincipal InvestigatorAlliance Foundation Trials, LLC.
12 Previous Clinical Trials
6,748 Total Patients Enrolled
1 Trials studying Multiple Myeloma
79 Patients Enrolled for Multiple Myeloma

Media Library

Dexamethasone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT03702725 — Phase 1
Multiple Myeloma Research Study Groups: Dose Escalation, Dose Expansion
Multiple Myeloma Clinical Trial 2023: Dexamethasone Highlights & Side Effects. Trial Name: NCT03702725 — Phase 1
Dexamethasone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03702725 — Phase 1
~1 spots leftby Mar 2025