Selvigaltin for Multiple Myeloma

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Roswell Park Cancer Institute

Must be taking: Daratumumab, Carfilzomib, Dexamethasone

Must not be taking: CYP3A4 inhibitors, QT prolonging

Disqualifiers: Heart failure, HIV, others

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

Compensation: Varies

Number of Visits: 4

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best dose and side effects of a new drug, selvigaltin, when combined with standard treatment for multiple myeloma, a type of blood cancer that recurs or resists previous treatments. Selvigaltin blocks a protein that can worsen cancer. The trial seeks individuals previously treated for multiple myeloma who plan to start treatment with a specific drug combination: daratumumab, carfilzomib, and dexamethasone. Participants should exhibit certain measurable signs of the disease, such as specific protein levels in blood or urine, or a certain percentage of cancer cells in the bone marrow. As a Phase 1 trial, this research focuses on understanding how selvigaltin works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but you cannot take certain drugs that strongly affect liver enzymes or heart rhythm unless they are essential for your care. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that selvigaltin is likely to be safe for humans?

Previous research indicates that selvigaltin, when combined with standard treatments, is safe and manageable for people with relapsed or hard-to-treat multiple myeloma. So far, selvigaltin hasn't shown major safety issues. Some studies found that even when the liver processes the drug, it doesn't cause serious problems. This is encouraging for those considering joining the trial, as early tests suggest selvigaltin is well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for multiple myeloma?

Selvigaltin is unique because it introduces a novel mechanism of action for treating multiple myeloma. Unlike traditional treatments like proteasome inhibitors or immunomodulatory drugs, Selvigaltin targets a specific pathway that cancer cells rely on for survival, potentially offering a more precise attack on the disease. Researchers are particularly excited about its potential to overcome resistance seen with existing therapies, opening up new possibilities for patients who have exhausted other options.

What evidence suggests that selvigaltin might be an effective treatment for multiple myeloma?

Research has shown that selvigaltin blocks a protein called galectin-3, linked to cancer-related inflammation and tissue scarring. This action may reduce harmful effects in multiple myeloma, a type of blood cancer. Although solid evidence on selvigaltin's effectiveness in humans remains limited, studies suggest it could be promising when combined with standard treatments for multiple myeloma. In this trial, participants will receive selvigaltin alongside daratumumab, carfilzomib, and dexamethasone, which are already effective for many patients. Selvigaltin might enhance these effects by reducing inflammation and tissue scarring, potentially improving outcomes for those whose multiple myeloma has returned or is not responding to treatment. ^{1 2 3 5 6}

Who Is on the Research Team?

Hamza Hassan

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 with relapsed or refractory multiple myeloma, who have had at least one prior therapy. They must have a certain level of M-protein in their blood or urine, more than 10% bone marrow plasma cells, and meet specific blood cell count criteria. Participants should be able to undergo standard treatment with daratumumab, carfilzomib, and dexamethasone.

Inclusion Criteria

My white blood cell count is above 1,000.

My blood test shows M-protein levels above 0.5 g/dL.

My urine M-protein level is over 200 mg/24h.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive selvigaltin with standard of care treatment for up to 6 cycles

24 weeks

Weekly visits for drug administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Monthly visits for the first year, then every 3 months

Extension

Participants may continue treatment beyond 6 cycles if responding well

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Selvigaltin

Trial Overview The trial is testing the safety and optimal dose of selvigaltin combined with standard care (daratumumab-hyaluronidase, carfilzomib, dexamethasone) for treating multiple myeloma that has returned or isn't responding to treatment. Selvigaltin aims to block galectin-3 protein activity which may reduce inflammation and tissue scarring associated with cancer progression.

How Is the Trial Designed?

Group I: Treatment (selvigaltin, Dara-KD) Experimental Treatment 13 Interventions

See Detailed Description.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07082270

Study Details | NCT07082270 | Selvigaltin With Standard of ... Giving selvigaltin with standard of care treatment may be safe, tolerable, and/or effective in treating patients with relapsed or refractory multiple myeloma.

2. myeloma.org myeloma.org/sparkcures/trial/2147

GB1211 (Selvigaltin) Combination Therapy Giving selvigaltin with standard of care treatment may be safe, tolerable, and/or effective in treating patients with relapsed or refractory multiple myeloma.

3. withpower.com withpower.com/trial/phase-1-multiple-myeloma-8-2025-4fd15

Selvigaltin for Multiple Myeloma · Info for Participants It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving selvigaltin with standard ...

4. sparkcures.com sparkcures.com/clinical-trials/multiple-myeloma

Multiple Myeloma Clinical Trials We help myeloma patients find, understand and connect with their clinical trial options at centers around the US.

5. clinicaltrials.eu clinicaltrials.eu/inn/gb1211/

Gb1211 – Application in Therapy and Current Clinical ... This article will provide an overview of the ongoing research on GB1211, including its safety, efficacy, and potential applications in diseases such as non- ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39358661/

Single‑Dose Pharmacokinetics and Safety of the Oral ... Conclusion: Hepatic impairment increased selvigaltin exposure without safety concerns. These data ... Associated data. ClinicalTrials.gov ...