Combination Therapies with Selinexor for Multiple Myeloma

(STOMP Trial)

Recruiting at 14 trial locations

Overseen By Karyopharm Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Karyopharm Therapeutics Inc

Must not be taking: CYP3A4 modulators

Disqualifiers: Amyloidosis, Plasma cell leukemia, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the safety and effectiveness of different combinations of the drug selinexor for people with multiple myeloma, a type of blood cancer. Researchers are testing several combinations of selinexor with other medications to treat both newly diagnosed and previously treated cases. Currently, the trial seeks participants with relapsed or refractory multiple myeloma who have undergone at least two prior treatments, including specific drug types, and who are ineligible for T-cell therapies like CAR-T. As a Phase 1 and Phase 2 trial, it focuses on understanding the treatment's mechanism and measuring its effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking strong CYP3A4 inhibitors or inducers, you may need to stop them before participating in the PK Run-in period for certain trial arms.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that selinexor, when combined with other drugs, generally maintains a known safety profile. The FDA has approved selinexor, often used with dexamethasone and other medications, for treating multiple myeloma, supporting its safety for patients.

Studies have found the combination of selinexor, dexamethasone, and pomalidomide to be generally tolerable for patients with relapsed or refractory multiple myeloma. Common side effects include nausea and fatigue, which are usually manageable.

The combination of selinexor, dexamethasone, and belantamab mafodotin also maintains a known safety profile. However, belantamab can cause eye-related side effects, so patients receive close monitoring for any vision issues.

For the combination of selinexor, dexamethasone, and mezigdomide, selinexor and dexamethasone have been used safely together in other treatments. Mezigdomide, when combined with dexamethasone, has shown promising safety data, indicating it is well-tolerated, especially in patients who have tried other treatments.

Overall, while side effects can occur, they are often manageable, and previous studies have shown a good safety profile for these treatments. Patients should discuss any concerns with their healthcare providers to understand what to expect and how to handle potential side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these combination therapies for multiple myeloma because they incorporate Selinexor, which works uniquely by blocking the protein XPO1, leading to cancer cell death. This mechanism is different from many standard treatments like proteasome inhibitors or immunomodulatory drugs. Additionally, combinations involving novel agents like Belantamab Mafodotin and Mezigdomide bring fresh approaches by targeting different pathways, potentially enhancing effectiveness and offering new hope for patients with resistant disease. Overall, these treatments aim to provide more options and improve outcomes for difficult-to-treat myeloma cases.

What evidence suggests that this trial's treatments could be effective for multiple myeloma?

Research has shown that combinations using selinexor are promising for treating multiple myeloma, especially in patients unresponsive to other treatments. In this trial, participants may receive different combinations of selinexor. For example, the combination of selinexor with pomalidomide and dexamethasone (SPd) reduced cancer in nearly 40% of patients. Another combination in this trial, selinexor with dexamethasone and daratumumab (SDd), proved very effective, benefiting 74% of patients whose cancer returned. Selinexor with carfilzomib and dexamethasone (SKd) also shows high success rates in patients who have undergone many previous treatments. While specific results for selinexor with dexamethasone and belantamab mafodotin (SBd) aren't detailed, studies suggest it could be beneficial. Lastly, the new combination of selinexor, dexamethasone, and mezigdomide (SMd) is under study for its unique effects, and early signs suggest it might help those with recurring or resistant multiple myeloma. ^{1 2 6 7 8}

Who Is on the Research Team?

Michael Kauffman, MD, Ph.D

Principal Investigator

Karyopharm Therapeutics Inc

Are You a Good Fit for This Trial?

Adults over 18 with symptomatic multiple myeloma, either newly diagnosed or relapsed/refractory, can join. They must have measurable disease and be in good enough health to swallow pills and handle treatment side effects. Pregnant women, those with severe liver/kidney issues, recent major surgery patients, or individuals with certain infections or heart problems cannot participate.

Inclusion Criteria

Written informed consent signed in accordance with federal, local, and institutional guidelines

My liver is functioning well, as tested within the last 28 days.

Any side effects from past treatments have mostly gone away.

Exclusion Criteria

I have been diagnosed with active systemic light chain amyloidosis.

I haven't had blood transfusions or growth factors in the last 14 days.

My multiple myeloma does not produce M-protein or light chains.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

PK Run-in

Selinexor pharmacokinetics run-in period to evaluate PK before and after co-administration with a strong CYP3A4 inhibitor

2 weeks

Multiple blood sample collections on Days 1 and 8

Dose-Escalation

Patients undergo dose-escalation to determine the maximum tolerated dose and recommended phase-2 dose

12 months

Regular visits for dosing and monitoring

Expansion

Phase 2 expansion to assess efficacy and safety of combination therapies

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Belantamab Mafodotin
• Bortezomib
• Carfilzomib
• Daratumumab
• Dexamethasone
• Elotuzumab
• Ixazomib
• Lenalidomide
• Pomalidomide
• Selinexor

Trial Overview The trial is testing Selinexor combined with other drugs like dexamethasone and chemotherapy agents in different mixtures across 11 groups for treating multiple myeloma. Some groups are closed to new participants. The study includes initial phases to determine safe dosages followed by expansions to assess effectiveness.

How Is the Trial Designed?

Group I: 9: Selinexor, Low-dose DEX, Pomalidomide and Elotuzumab (SPEd) Experimental Treatment 4 Interventions

PK Run-in Period: Selinexor and Clarithromycin: * For the first 9 patients enrolled into this dose escalation arm * 14 day run-in period after which patient will proceed to Dose-Escalation Phase C1D1 Selinexor 40 mg will be dosed on Days 1 and 8. Clarithromycin 500 mg will be dosed twice daily on Days 2-8. PK samples will be collected on Days 1 and 8 at 1, 1.5, 2, 3, 4, 5, 6, 8, and 24 hours post dose. Dose-Escalation Phase: * All patients enrolled into this Arm * Each cycle is of 28 days Cohort 9.1: SEL 20/40/60 mg PO once weekly; DEX 28/20 mg PO twice weekly; POM 4 mg PO QD Days 1-21; Elotuzumab (ELO) 10/20 mg/kg IV will be given once weekly on Days 1,8, 15 and 22 of Cycles 1-2. Starting on Cycle 3 and continuing for future cycles, elotuzumab will be dosed at 20 mg/kg on Day 1 of each cycle only. Cohort 9.3: Selinexor, Dexamethasone, Pomalidomide and Elotuzumab will be dosed at RP2D-9.

Group II: 8: Selinexor, Low-dose dexamethasone, and Ixazomib (SNd) Experimental Treatment 4 Interventions

PK Run-in Period: Selinexor \& Clarithromycin: * For the first 9 patients enrolled into this dose escalation arm * 14 day run-in period after which patient will proceed to Dose-Escalation Phase C1D1 Selinexor 40 mg will be dosed on Days 1 and 8. Clarithromycin 500 mg will be dosed twice daily on Days 2-8. PK samples will be collected on Days 1 and 8 at 1, 1.5, 2, 3, 4, 5, 6, 8, and 24 hours post dose. Dose-Escalation Phase: * All patients enrolled into this Arm * Each cycle is of 28 days Cohort 8.1: SEL 40/60/80/100 mg PO once weekly; DEX 20 mg PO twice weekly; IXA 3/4 mg PO once weekly. Cohort 8.3: Selinexor, Dexamethasone and Ixazomib will be dosed at RP2D-8.

Group III: 7: Selinexor, Low-dose DEX and Lenalidomide (SRd) in NDMM Experimental Treatment 3 Interventions

Each cycle is of 28 days Cohort 7.1: SEL 40/60/80 mg PO once weekly; DEX 40 mg PO once weekly; LEN 25 mg PO Days 1-21. Cohort 7.3: Selinexor, Dexamethasone and Lenalidomide will be dosed at RP2D-7.

Group IV: 6: Selinexor, Low-dose dexamethasone, and Carfilzomib (SKd) Experimental Treatment 4 Interventions

PK Run-in Period: Selinexor and Clarithromycin: * For the first 9 patients enrolled into this dose escalation arm * 14 day run-in period after which patient will proceed to Dose-Escalation Phase C1D1 Selinexor 40 mg will be dosed on Days 1 and 8. Clarithromycin 500 mg will be dosed twice daily on Days 2-8. PK samples will be collected on Days 1 and 8 at 1, 1.5, 2, 3, 4, 5, 6, 8, and 24 hours post dose. Dose-Escalation Phase: * All patients enrolled into this Arm * Each cycle is of 28 days Cohort 6.1: SEL 40/60/80/100 mg PO once weekly on days 1, 8, 15, and 22; DEX 40 mg IV or PO once weekly; Carfilzomib (CAR) 56 or 70 mg/m\^2 IV infusion once weekly on days 1, 8, and 15. Cohort 6.2: SEL 60/80/100 mg PO once weekly on days 1, 8, and 15; DEX 40 mg IV or PO once weekly; CAR 56 or 70 mg/m\^2 IV infusion once weekly on days 1, 8, and 15. Cohort 6.3: Selinexor, Dexamethasone and Carfilzomib will be dosed at RP2D-6.

Group V: 5: Selinexor, Low-dose dexamethasone, and Daratumumab (SDd) Experimental Treatment 3 Interventions

Each cycle is of 28 days Cohort 5.1: SEL 80/100 mg PO once weekly; DEX 40 mg once weekly (IV or PO); DARA: 16 mg/kg IV infusion Cycle 1-2: Once weekly, Cycle 3-6: Every other week, Cycle 6 and greater: Once a month. Cohort 5.2: SEL: 60 mg PO twice weekly; DEX: 40 mg weekly (IV or PO); DARA: 16 milligram per kilogram (mg/kg) IV infusion Cycle 1-2: Once. weekly, Cycle 3-6: Every other week, Cycle 6 and greater: Once a month. Cohort 5.3: Selinexor, Dexamethasone and Daratumumab will be dosed at RP2D-5.

Group VI: 4:Selinexor, Low-dose dexamethasone, Pomalidomide, Velcade (SPVd) Experimental Treatment 5 Interventions

PK Run-in Period: Selinexor and Clarithromycin: * For the first 9 patients enrolled into this dose escalation arm * 14 day run-in period after which patients will proceed to Dose-Escalation Phase C1D1 Selinexor 40 mg will be dosed on Days 1 and 8. Clarithromycin 500 mg will be dosed twice daily on Days 2-8. PK samples will be collected on Days 1 and 8 at 1, 1.5, 2, 3, 4, 5, 6, 8, and 24 hours post dose. Dose-escalation Phase: * All patients enrolled into this Arm * Each cycle is of 28 days. Cohort 4.1: SEL 40/60 mg PO once weekly; DEX 40 mg PO once weekly; POM 4 mg PO Days 1-21; BOR 1.3 mg/m\^2 subcutaneous (SC) once weekly. Cohort 4.3: Selinexor, Dexamethasone, Pomalidomide, Velcade (Bortezomib) will be dosed at RP2D-4.

Group VII: 3: Selinexor, Low-dose DEX, and Lenalidomide (SRd) in RRMM Experimental Treatment 3 Interventions

Each cycle is of 28 days Cohort 3.1: SEL 40/60/80/100 mg PO once weekly; DEX 40 mg PO once weekly; Lenalidomide (LEN) 15/25 mg PO Days 1-21. Cohort 3.2: SEL 40/60/80 mg PO twice weekly; DEX 20 mg PO twice weekly; LEN 15/25 mg PO Days 1-21. Cohort 3.3: Selinexor, Dexamethasone and Lenalidomide will be dosed at RP2D-3.

Group VIII: 2: Selinexor, Low-dose Dexamethasone and Bortezomib (SVd) Experimental Treatment 3 Interventions

Each cycle is of 35 days Cohort 2.1: SEL 60/80/100 mg PO once weekly; DEX 40 mg PO once weekly; Bortezomib (BOR) 1.3 milligram per meter square (mg/m\^2) subcutaneous (SC) once weekly. Cohort 2.2: SEL 40/60/80 mg PO twice weekly; DEX 20 mg PO twice weekly; BOR 1.3 mg/m\^2 subcutaneous (SC) once weekly. Cohort 2.3: Selinexor, Dexamethasone and Bortezomib will be dosed at RP2D-2.

Group IX: 1: Selinexor, Low-dose Dexamethasone and Pomalidomide (SPd) Experimental Treatment 3 Interventions

Each cycle is of 28 days Cohort 1.1: Selinexor (SEL) 60/80/100 mg orally (PO) once weekly (QW); Dexamethasone (DEX) 40 mg PO once weekly; Pomalidomide (POM) 2/3/4 mg PO Days 1-21. Cohort 1.2: SEL 40/60/80 mg PO twice weekly (BIW); DEX 20 mg PO twice weekly; POM 3/4 mg PO Days 1-21. Cohort 1.3: Selinexor, Dexamethasone and Pomalidomide will be dosed at RP2D-1. Cohort 1.4: SEL 40 mg PO QW; DEX 40 mg PO QW; POM 4mg PO once daily (QD) Days 1-21.

Group X: 12. Selinexor + dexamethasone + mezigdomide (SMd) Experimental Treatment 3 Interventions

The dose of selinexor will be formally escalated from 40 mg QW to 60 mg QW in combination with mezigdomide 0.6 mg daily. Mezigdomide dosing may be de-escalated as per 3+3 criteria to 0.3 mg or escalated to 1.0 mg. The dose level that passes DLT evaluation will be considered the MTD for the cohort.

Group XI: 11. Selinexor, Dexamethasone, Pomalidomide, and Daratumumab (SDPd) Experimental Treatment 4 Interventions

Each Cycle is of 28 days Cohort 11.1 SEL 40/60 mg PO once weekly on Days 1, 8, and 15; DEX total 40 mg weekly (IV or PO) single or divided doses on Days 1, 8, 15, and 22; POM 4 mg PO QW Days 1-21; DARA 16 mg/kg IV or SC QW on Days 1, 8, 15 and 22 of Cycles 1-2 and on Days 1 and 15 of Cycles 3-6, Day 1 of every Cycle greater than (\>6). Cohort 11.3 Selinexor, Dexamethasone, Pomalidomide, and Daratumumab will be dosed at RP2D-11.

Group XII: 10. Selinexor, Dexamethasone, and Belantamab Mafodotin (SBd) Experimental Treatment 3 Interventions

Each cycle is of 21 days Cohort 10.1: SEL 40/60/80 mg PO once weekly on Days 1, 8, and 15; DEX 40 mg PO QW on Days 1, 8, and 15; Belantamab Mafodotin (BEL) 2.5 mg/kg IV infusion every 3 weeks (Q3W) Day 1 of each cycle. Cohort 10.3: Selinexor, Dexamethasone, and Belantamab Mafodotin will be dosed at RP2D-10.

Belantamab Mafodotin is already approved in European Union, United States for the following indications:

Approved in European Union as Blenrep for:

• Relapsed or refractory multiple myeloma

Approved in United States as Blenrep for:

• Relapsed or refractory multiple myeloma

Who Is Running the Clinical Trial?

Karyopharm Therapeutics Inc

Lead Sponsor

Trials

89

Recruited

7,200+

Richard Paulson

Karyopharm Therapeutics Inc

Chief Executive Officer since 2021

MBA from the University of Toronto's Rotman School of Management

Reshma Rangwala

Karyopharm Therapeutics Inc

Chief Medical Officer since 2023

MD, PhD

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Published Research Related to This Trial

In a phase I trial involving 21 patients with relapsed/refractory multiple myeloma, the combination of selinexor, carfilzomib, and dexamethasone was found to be tolerable, with a recommended phase II dose established at selinexor 60 mg, carfilzomib 20/27 mg/m2, and dexamethasone 20 mg.

The treatment resulted in significant response rates, with 71% of patients achieving at least a minimal response and a median overall survival of 22.4 months, demonstrating its efficacy even in patients who were refractory to carfilzomib.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1 study of selinexor plus carfilzomib and dexamethasone for the treatment of relapsed/refractory multiple myeloma. Jakubowiak, AJ., Jasielec, JK., Rosenbaum, CA., et al.[2023]

Belantamab mafodotin (belamaf) is an effective treatment for relapsed or refractory multiple myeloma, showing a 32% overall response rate in the phase II DREAMM-2 study with 95 patients.

While most patients experienced microcyst-like epithelial changes (MECs) as a side effect, these were generally manageable, with a high resolution rate and no permanent vision loss reported, indicating a need for careful monitoring and collaboration between eye care and oncology professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Corneal Epithelial Findings in Patients with Multiple Myeloma Treated with Antibody-Drug Conjugate Belantamab Mafodotin in the Pivotal, Randomized, DREAMM-2 Study. Farooq, AV., Degli Esposti, S., Popat, R., et al.[2020]

In a real-world study of 28 multiple myeloma patients who had undergone a median of six prior treatments, belantamab-mafodotin demonstrated an overall response rate of 40%, with some patients achieving complete remission and a median overall survival of 8 months.

The treatment was generally well-tolerated, with keratopathy being the most common side effect in 32% of patients, but only leading to discontinuation in 11%, indicating a favorable safety profile in this challenging patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of belantamab-mafodotin in triple-refractory multiple myeloma patients: A multicentric real-life experience. Iula, R., De Novellis, D., Trastulli, F., et al.[2022]

Selinexor is a first-in-class oral medication that works by inhibiting nuclear export, leading to the retention of oncogene mRNAs and reactivation of tumor suppressor proteins, which triggers cell death in multiple myeloma (MM) cells.

In clinical studies, selinexor has shown manageable side effects and promising effectiveness in treating relapsed and refractory MM, indicating its potential to improve outcomes for patients with limited treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selinexor for the treatment of patients with previously treated multiple myeloma. Mo, CC., Jagannath, S., Chari, A., et al.[2022]

Belantamab mafodotin (BLENREP) received accelerated FDA approval for treating relapsed or refractory multiple myeloma in adults who have undergone at least four prior therapies, showing an overall response rate of 31% to 34% in the DREAMM-2 trial with 2.5 or 3.4 mg/kg doses.

The most common side effect was keratopathy, affecting 71% to 77% of patients, leading to a boxed warning for ocular toxicity, indicating the need for careful monitoring and a restricted distribution program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Belantamab Mafodotin for Patients with Relapsed or Refractory Multiple Myeloma. Baines, AC., Ershler, R., Kanapuru, B., et al.[2023]

Selinexor and belantamab mafodotin are FDA-approved treatments for patients with relapsed/refractory multiple myeloma, but they come with significant toxicity concerns, particularly thrombocytopenia and other hematological issues.

Management of side effects often requires treatment modifications, and ongoing monitoring is essential due to the limited data on these newer drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Profile and Management of Toxicity of Selinexor and Belantamab Mafodotin for the Treatment of Triple Class Refractory Multiple Myeloma. Neupane, K., Wahab, A., Masood, A., et al.[2021]

Selinexor, when used in combination with dexamethasone or bortezomib and dexamethasone, showed an overall response rate of 29.5% in 44 patients with relapsed or refractory myeloma, indicating its efficacy as a treatment option.

The most common side effects included fatigue and thrombocytopenia, with 56% of patients requiring dose reductions; however, these adjustments did not negatively impact progression-free survival, suggesting that selinexor can be managed safely in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real World Efficacy and Toxicity of Selinexor: Importance of Patient Characteristics, Dose Intensity and Post Progression Outcomes. Kastritis, E., Gavriatopoulou, M., Solia, E., et al.[2023]

Selinexor, a first-in-class oral medication that inhibits the nuclear export protein XPO-1, has been granted accelerated FDA approval for treating patients with penta-refractory multiple myeloma, showing promise in a challenging patient population.

Clinical data indicates that selinexor, particularly in combination with dexamethasone, represents a significant advancement in treatment options for heavily pretreated multiple myeloma patients, with ongoing studies exploring its use in earlier treatment lines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selinexor for the treatment of multiple myeloma. Podar, K., Shah, J., Chari, A., et al.[2023]

In the phase 3 BOSTON trial, the combination of selinexor, bortezomib, and dexamethasone significantly improved progression-free survival in adults with previously treated multiple myeloma compared to the standard bortezomib-dexamethasone regimen.

This triplet therapy demonstrated a manageable safety profile, with a lower incidence of peripheral neuropathy compared to the standard treatment, making it a promising option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selinexor-Bortezomib-Dexamethasone: A Review in Previously Treated Multiple Myeloma. Syed, YY.[2023]

The combination of selinexor, carfilzomib, and dexamethasone (XKd) demonstrated a high overall response rate of 78% in patients with relapsed refractory multiple myeloma, indicating strong efficacy.

The treatment was well-tolerated, with manageable side effects such as thrombocytopenia and nausea, and the maximum-tolerated dose was established as selinexor 80 mg, carfilzomib 56 mg/m2, and dexamethasone 40 mg, all administered weekly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Once weekly selinexor, carfilzomib and dexamethasone in carfilzomib non-refractory multiple myeloma patients. Gasparetto, C., Schiller, GJ., Tuchman, SA., et al.[2022]

Selinexor, when combined with low-dose bortezomib and dexamethasone, showed a 63% overall response rate in treating relapsed or refractory multiple myeloma, with particularly high efficacy in patients not previously resistant to proteasome inhibitors (84% response rate).

The treatment was generally well-tolerated, with the most common severe side effects being thrombocytopenia (45%) and neutropenia (24%), while the recommended phase 2 dose was established as selinexor 100 mg once weekly, bortezomib 1.3 mg/m2 once weekly, and dexamethasone 40 mg once weekly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selinexor plus low-dose bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma. Bahlis, NJ., Sutherland, H., White, D., et al.[2021]

In a study of 156 patients with relapsed and refractory multiple myeloma, belantamab-mafodotin (belamaf) demonstrated an overall response rate of 41.8%, with significant improvements in progression-free survival for those achieving at least minimal response (MR).

The safety profile of belamaf was manageable, with corneal events being the most common adverse effects, affecting 87.9% of patients, though only 1.3% discontinued treatment due to ocular toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Belantamab Mafodotin in Patients with Relapsed/Refractory Multiple Myeloma: Results of the Compassionate Use or the Expanded Access Program in Spain. de la Rubia, J., Alonso, R., Clavero, ME., et al.[2023]

Selinexor, an exportin-1 inhibitor, has received regulatory approval for treating multiple myeloma and non-Hodgkin lymphomas based on pivotal trials, including the SADAL and BOSTON trials, demonstrating its potential as a monotherapy or in combination regimens.

While selinexor shows promise in overcoming treatment resistance and may have synergistic effects with other therapies, it has consistent tolerability issues, necessitating improved management strategies to enhance its efficacy compared to newer cellular and immunotherapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selinexor therapy for multiple myeloma and non-Hodgkin lymphomas. Goldsmith, SR., Liu, L., Shiah, K.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8523001/

DREAMM-2: Indirect Comparisons of Belantamab Mafodotin ... Single-agent belantamab mafodotin (belamaf; BLENREP) demonstrated deep and durable responses in patients with relapsed/refractory multiple myeloma and ≥ 3 prior ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02343042

Study Details | NCT02343042 | Selinexor and Backbone ... This study will independently assess the efficacy and safety of 11 combination therapies in 12 arms, in dose-escalation/-evaluation and expansion phases.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2152265025042302

Treatment of Myeloma Early Relapse –Non CAR-T Cell DREAMM-7 demonstrated the superior efficacy of the combination of belantamab mafodotin, bortezomib and dexamethasone (BelaVd) compared to DaraVd ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.36_suppl.439572

Results from the randomized phase III DREAMM-7 study of ... DREAMM-2: Assessing efficacy via indirect comparison of single-agent belantamab mafodotin versus selinexor plus dexamethasone combination in ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/jha2.913

Selinexor in combination with dexamethasone with or ... This report describes the characteristics and outcomes of 18 heavily pretreated patients with multiple myeloma (MM) who were subsequently treated with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8257048/

Profile and Management of Toxicity of Selinexor and ... Selinexor (Sel) and belantamab mafodotin (belamaf) were recently approved by the US FDA for treatment of RRMM. The toxicity profile of these ...

7. annalsofoncology.org annalsofoncology.org/article/S0923-7534(20)40015-8/fulltext

901P Matching-adjusted indirect comparisons (MAIC) of ... 901P Matching-adjusted indirect comparisons (MAIC) of safety between single-agent belantamab mafodotin versus selinexor plus dexamethasone in relapsed/ ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S295032802500038X

Belantamab mafodotin in patients with relapsed/refractory ... In summary, belantamab mafodotin showed significant ORR, including those of patients with prior BCMA exposure. Ocular toxicity was similar to that in previous ...