NMS-03597812 + Dexamethasone for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Nerviano Medical Sciences

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a Phase I, first-in-human (FIH), open-label, non-randomized, multi-center study to explore the safety, tolerability, pharmacokinetics and preliminary antitumor activity of NMS-03597812 in adult patients with RRMM who have exhausted standard treatment options that are expected to provide meaningful clinical benefit or for whom standard therapy is considered unsuitable.

Eligibility Criteria

Adults over 18 with relapsed or refractory multiple myeloma, who've tried at least three prior treatments including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 antibody. They must have measurable disease and be able to swallow capsules. Excluded are those with certain heart conditions, recent major surgery, active infections like HIV/HBV/HCV, uncontrolled diabetes or other serious medical issues.

Inclusion Criteria

Patients must use effective contraception or abstinence

I am a woman who can have children and have a negative pregnancy test before starting the study drug.

All side effects from my previous treatments, except for hair loss, are mild or gone.

Exclusion Criteria

I am taking medication that cannot be replaced and is sensitive to certain enzymes.

I do not have any uncontrolled infections and am not HIV, HBV, or HCV positive.

I haven't taken cancer drugs in the last 3 weeks, or immunotherapy in the last 6 weeks.

Treatment Details

Interventions

• Dexamethasone (Corticosteroid)
• NMS-03597812 (Other)

Trial Overview The trial is testing NMS-03597812 alone or combined with dexamethasone in patients whose multiple myeloma has not responded to standard treatments. It's an early-phase study focusing on safety and how the body processes the drugs.

Participant Groups

Group I: Dose Expansion Part - NMS-03597812 single agent Experimental Treatment 1 Intervention

Patients with a confirmed diagnosis of relapsed or relapsed and refractory multiple myeloma (as per IMWG criteria) who have exhausted standard treatment options that are expected to provide meaningful clinical benefit or for whom standard therapy is considered unsuitable

Group II: Dose Expansion Part - NMS-03597812 in combination with dexamethasone Experimental Treatment 1 Intervention

Patients with a confirmed diagnosis of relapsed or relapsed and refractory multiple myeloma (as per IMWG criteria) who have exhausted standard treatment options that are expected to provide meaningful clinical benefit or for whom standard therapy is considered unsuitable

Group III: Dose Escalation Part Experimental Treatment 1 Intervention

Patients with a confirmed diagnosis of relapsed or relapsed and refractory multiple myeloma (as per IMWG criteria) who have exhausted standard treatment options that are expected to provide meaningful clinical benefit or for whom standard therapy is considered unsuitable

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Chicago Medical Center Chicago, IL

Levine Cancer Institute Charlotte, NC

Sylvester Comprehensive Cancer Center Miami, FL

Dana- Farber Cancer Institute Boston, MA

Who Is Running the Clinical Trial?

Nerviano Medical Sciences Lead Sponsor

References