Iberdomide Maintenance Therapy for Multiple Myeloma
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen bySarah Holstein, MD/PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Nebraska
Must not be taking: Immunosuppressants, CYP3A4/5 inducers
Disqualifiers: Pregnancy, Disease progression, Plasma cell leukemia, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial is testing a medication called iberdomide to see if it can help prevent cancer from returning in patients who have had a stem cell transplant. The medication is taken by mouth and helps the immune system fight off any leftover cancer cells. The study will check if this treatment is safe and effective for these patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you've used certain medications like strong inhibitors or inducers of CYP3A4/5, or immunosuppressive medications within 14 days before starting the trial.
What data supports the effectiveness of the drug Iberdomide for multiple myeloma?
Iberdomide has shown enhanced tumor-killing and immune-boosting effects in preclinical models of multiple myeloma, especially when combined with other treatments like dexamethasone. It is also highly specific to certain proteins involved in the disease, which may help in treating patients who have become resistant to other therapies.
12345Is Iberdomide safe for humans?
Iberdomide has been studied in combination with dexamethasone for patients with multiple myeloma, focusing on its safety and clinical activity. While specific safety data for Iberdomide alone is not detailed, it is part of a class of drugs known as immunomodulatory drugs, which have shown serious side effects in some cases, such as pneumonia and sepsis. Further research is needed to fully understand its safety profile.
24567Eligibility Criteria
This trial is for adults with Multiple Myeloma who've had a stem cell transplant and are in partial or better response. They must have good organ function, no prior progression after initial therapy, and not be on other clinical trials. Women of childbearing potential must use contraception; men must agree to abstain or use condoms.Inclusion Criteria
I am at least 18 years old, or 19 if I live in Nebraska.
I can become pregnant and agree to use two forms of birth control or practice abstinence.
I have been diagnosed with active Multiple Myeloma.
+5 more
Exclusion Criteria
I have a type of blood cancer that doesn't produce typical markers.
Within the past 14 days, you have had low levels of certain blood cells, high levels of calcium in your blood, or liver or kidney problems.
I do not have severe nerve damage, major gut issues affecting drug absorption, or trouble swallowing pills.
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Iberdomide maintenance therapy post-autologous stem cell transplant, dosed at 1.0 mg PO daily for days 1-21 of a 28-day cycle
Until disease progression or toxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment
5 years
Participant Groups
The study tests the safety and effectiveness of iberdomide as maintenance therapy post-stem cell transplant in Multiple Myeloma patients. It will continue until disease progression or unacceptable toxicity occurs, comparing its results potentially with lenalidomide maintenance.
1Treatment groups
Experimental Treatment
Group I: IberdomideExperimental Treatment1 Intervention
Iberdomide will be dosed at 1.0 mg PO daily for days 1-21 of a 28-day cycle
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Nebraska Medical CenterOmaha, NE
Roswell Park Cancer InstituteBuffalo, NY
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Who Is Running the Clinical Trial?
University of NebraskaLead Sponsor
References
Options at the time of relapse after anti-BCMA therapy. [2023]B-cell maturation antigen (BCMA)-directed therapies, including antibody-drug conjugates, bispecific antibodies (BsAbs), and chimeric antigen receptor T cells (CARTs), have shown remarkable efficacy in patients with late-line myeloma with prior exposure to immunomodulatory agents, proteasome inhibitors, and anti-CD38 antibodies. However, optimal sequencing of these agents remains to be determined, and management of these patients once they relapse has become a new unmet need. Fortunately, there are multiple options with demonstrated activity after anti-BCMA therapy, including a different BCMA-directed therapy, non-BCMA-directed CARTs and BsAbs, novel non-T-cell-engaging drugs, and standard triplet/quadruplet regimens or salvage stem cell transplant. Factors to consider when choosing a next therapy after anti-BCMA therapy include patient characteristics and preferences, prior therapies and toxicities, disease biology, timing from last anti-BCMA therapy, and, in the future, BCMA expression and immune profiling. While current data are limited to retrospective studies and small prospective cohorts, the serial use of T-cell-engaging therapies looks particularly promising, especially as BCMA-directed therapies move up earlier in the myeloma treatment course and additional CARTs and BsAbs against alternative targets (eg, G protein-coupled receptor, family C, group 5, member D and Fc receptor-homolog 5) become available. Going forward, ongoing prospective studies, large real-world data sets, and better tools to interrogate antigen expression and immune cell fitness hopefully will provide further insight into how to best individualize therapy for this difficult-to-treat population.
From the bench to the bedside: emerging new treatments in multiple myeloma. [2023]Within the last decade, several novel classes of anti-myeloma therapeutics have become available. The clinical successes achieved by thalidomide, lenalidomide, and the proteasome inhibitor bortezomib, and in particular the ability of these agents to lead to major clinical responses in patients resistant to conventional or high-dose chemotherapy, have highlighted the importance of expanding further the spectrum of classes of agents utilized for the treatment of myeloma. Herein, we review the current status for the development of novel anti-myeloma agents, with emphasis on classes of therapeutics which have already translated into clinical trials or those in advanced stages of preclinical development. These include second-generation proteasome inhibitors (NPI-0052 and PR-171), heat shock protein 90 (hsp90) inhibitors, 2-methoxyestradiol, histone deacetylase (HDAC) inhibitors (e.g. SAHA and LBH589), fibroblast growth factor receptor 3 (FGF-R3) inhibitors, insulin-like growth factor 1 receptor (IGF-1R) inhibitors, mTOR inhibitors, monoclonal antibodies, and agents specifically targeting the tumor microenvironment, such as defibrotide.
[Effect of BD Regimen Combined with Cyclophosphamide and Pirarubicin in Treatment of Relapse/Refractory Multiple Myeloma]. [2018]To compare the efficacy and safety of BD regimen combined with cyclophosphamide(CTX) and pirarubicin chemotherapy(P-CAD) for patients with relapse/refractory multiple myeloma(MM).
Iberdomide plus dexamethasone in heavily pretreated late-line relapsed or refractory multiple myeloma (CC-220-MM-001): a multicentre, multicohort, open-label, phase 1/2 trial. [2022]Iberdomide is a novel cereblon E3 ligase modulator with enhanced tumouricidal and immune-stimulatory effects compared with immunomodulatory drugs. In preclinical myeloma models, iberdomide has shown synergy with dexamethasone, proteasome inhibitors, and CD38 monoclonal antibodies. We aimed to evaluate the safety and clinical activity of iberdomide plus dexamethasone in patients with heavily pretreated relapsed or refractory multiple myeloma.
A review on the treatment of multiple myeloma with small molecular agents in the past five years. [2022]Multiple myeloma is currently incurable, and the incidence rate is increasing year by year worldwide. Although in recent years the combined treatment plan based on proteasome inhibitors and immunomodulatory drugs has greatly improved the treatment effect of multiple myeloma, most patients still relapse and become resistant to current treatments. To solve this problem, scientists are committed to developing drugs with higher specificity, such as iberdomide, which is highly specific to ikaros and aiolos. This review aims to focus on the small molecular agents that are being researched/clinically used for the treatment of multiple myeloma, including the target mechanism, structure-activity relationship and application prospects of small molecular agents.
Post-marketing safety of immunomodulatory drugs in multiple myeloma: A pharmacovigilance investigation based on the FDA adverse event reporting system. [2022]Objective: In recent years, the emergence of immunomodulatory drugs (IMiDs) has significantly improved clinical outcomes in patients with multiple myeloma (MM); however, serious adverse events (AEs) have hindered their safe clinical application. This study aimed to characterize the safety profiles and differences in IMiDs through a disproportionality analysis using the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS), a post-marketing surveillance database. Methods: This study filtered reports of thalidomide, lenalidomide, and pomalidomide as primary suspect drugs in FAERS files from January 2013 to December 2021. AEs in the reports were retrieved according to the preferred terms (PTs) of the Medical Dictionary for Regulatory Activities. Furthermore, we detected safety signals using the reporting odds ratio (ROR), proportional reporting ratio (PRR), and Bayesian belief propagation neural network (BCPNN). When all three algorithms showed an association between the target drug and the AE, a positive signal was generated. Results: We extracted 9,968 thalidomide, 231,926 lenalidomide, and 55,066 pomalidomide AE reports. AEs were more common in male patients and in those >44 years old. Important safety signals were detected based on the system organ classes (SOC), including thalidomide (cardiac disorders: ROR, 2.87; PRR, 2.79; IC 1.22), lenalidomide (gastrointestinal disorders: ROR, 2.38; PRR, 2.27; IC 0.75), and pomalidomide (respiratory, thoracic, and mediastinal disorders: ROR, 2.14; PRR, 2.09; IC 0.85). Within the PT level, we identified novel risk signals: the thalidomide-induced second primary malignancy (SPM) signal was significant; lenalidomide reduced the success rate of hematopoietic stem cell collection; and three IMiDs may cause human chorionic gonadotropin increase, but this needs to be proven by clinical data. Pneumonia, sepsis, and renal failure are common risk factors for death due to IMiDs. Compared with thalidomide and lenalidomide, pomalidomide has a lower risk of venous thromboembolism (VTE) and is beneficial to patients with renal insufficiency. Conclusion: Mining data from FAERS resulted in novel AE signals, including adenocarcinoma of colon, harvest failure of blood stem cells, and increased levels of human chorionic gonadotropin. Further investigation is required to verify the significance of these signals. Moreover, IMiDs showed differences in safety reports, which should be emphasized by clinicians.
Efficacy and safety of bortezomib plus dexamethasone therapy for refractory or relapsed multiple myeloma: once-weekly administration of bortezomib may reduce the incidence of gastrointestinal adverse events. [2015]To establish the clinical use of bortezomib with fewer adverse events, we retrospectively analyzed the efficacy and safety of bortezomib plus dexamethasone (BD) therapy for relapsed or refractory multiple myeloma.