Selinexor for Smoldering Multiple Myeloma

Overseen By Jodi Lipof

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Rochester

Must not be taking: Systemic corticosteroids

Disqualifiers: Symptomatic MM, Amyloidosis, Active malignancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

15 Participants Needed

Trial Summary

What is the purpose of this trial?

Selinexor is a drug that has been approved in the treatment of patients with symptomatic multiple myeloma. The standard of care for patients with Smoldering Multiple Myeloma remains observation, but there are numerous clinical trials investigating interventions to delay progression to multiple myeloma and prevent or delay disease related outcomes. A subset of patients with intermediate or high risk smoldering multiple myeloma have a much higher risk of progressive to multiple myeloma, while the low risk smoldering myeloma patient population has a much lower risk. This is a clinical trial investigating the use of low-dose selinexor in patients with intermediate to high-risk smoldering multiple myeloma. The investigators hypothesize that the use of selinexor in intermediate to high risk smoldering myeloma patients will help to delay progression of disease to symptomatic multiple myeloma.

Research Team

Jodi Lipof

Principal Investigator

University of Rochester

Eligibility Criteria

This trial is for adults over 18 with intermediate to high-risk Smoldering Multiple Myeloma (SMM), which hasn't progressed to full-blown multiple myeloma. Participants need proper liver and kidney function, no severe bone damage from the disease, and a life expectancy of more than a year. They must not have other active cancers or infections, be pregnant, or refuse effective contraception.

Inclusion Criteria

You must have certain levels of specific substances in your blood, healthy liver and kidney function, and good blood cell counts. You must also have a good life expectancy, be in good overall health, and use effective birth control during the study.

I have been diagnosed with smoldering multiple myeloma as per IMWG standards.

I don't have high calcium, anemia, bone damage, or kidney issues due to my blood disorder.

Exclusion Criteria

You have certain symptoms related to a plasma cell disorder, such as high calcium levels, kidney problems, anemia, bone lesions, or specific levels of plasma cells and proteins in your blood. You also have other medical conditions or treatments that may interfere with the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Selinexor 40mg weekly for up to 12 cycles, with each cycle being 28 days in length

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

• Selinexor

Trial Overview The study tests low-dose Selinexor in patients with SMM at intermediate or high risk of developing symptomatic multiple myeloma. The goal is to see if Selinexor can delay the progression of SMM to an active form of cancer.

Participant Groups

Group I: Experimental: Treatment Experimental Treatment 1 Intervention

Selinexor 40mg weekly for up to 12 cycles. Each cycle will be 28 days in length.

Selinexor is already approved in United States, Canada for the following indications:

Approved in United States as Xpovio for:

• Multiple myeloma
• Diffuse large B-cell lymphoma

Approved in Canada as Xpovio for:

• Multiple myeloma

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Karyopharm Therapeutics Inc

Industry 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