Assessing a new treatment for relapsed and refractory multiple myeloma
A Phase 1b, Dose Escalation/Dose Expansion, Multicenter, Open-Label Study to Assess the Safety and Tolerability of OPN-6602 Monotherapy and in Combination With Dexamethasone in Subjects With Relapsed and/or Refractory Multiple Myeloma
This study is testing a new treatment called OPN-6602, alone and with another medication, to see if it can help people with relapsed or hard-to-treat multiple myeloma feel better and stay safe during the process.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Opna Bio LLC Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 11 sites (Gilbert, Arizona and 10 other locations) |
| Trial ID | NCT06433947 on ClinicalTrials.gov |
What this trial studies
This Phase 1b open-label study evaluates the safety and tolerability of OPN-6602, both as a standalone treatment and in combination with dexamethasone, for patients with relapsed and/or refractory multiple myeloma. The study will also assess the pharmacokinetics, preliminary antitumor activity, and pharmacodynamics of the treatment. Participants will be closely monitored to determine the effectiveness and safety of the drug regimen over the course of the trial.
Who should consider this trial
Good fit: Ideal candidates are individuals with a confirmed diagnosis of relapsed or refractory multiple myeloma who have not responded to multiple prior therapies.
Not a fit: Patients with conditions such as monoclonal gammopathy of undetermined significance or those who have had recent stem cell transplants may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat multiple myeloma.
How similar studies have performed: Other studies exploring similar treatment approaches have shown promise, but this specific combination is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed diagnosis of multiple myeloma (MM) * Relapsed or refractory to 3 or more different prior lines of therapy for MM that included immunomodulatory agents, proteosome inhibitors, and anti-CD38 antibody and not a candidate for or intolerant to established therapy known to provide clinical benefit * Adequate hematologic, renal, liver, cardiac function Exclusion Criteria: * Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, Waldenström's macroglobulinemia, or IgM myeloma * Active plasma cell leukemia * Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS syndrome) * Prior Stevens Johnson syndrome * Localized radiation therapy to disease site(s) within 2 weeks of the first dose * Prior autologous peripheral stem cell transplant or prior autologous bone marrow transplantation within \<90 days of the first dose of study drug * Prior allogeneic stem cell transplantation or solid organ transplantation within 12 months of first dose of study drug; subjects receiving immunosuppressive medication for active graft vs host disease will be excluded. * Prior chemotherapy, targeted anticancer or radiation therapy within 2 weeks prior to first dose of study drug * Concomitant high-dose corticosteroids (except subjects on chronic steroids given for disorders other than myeloma) * Known central nervous system involvement by multiple myeloma * Active known second malignancy with exception of adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer; adequately treated Stage 1 cancer from which the subject is currently in remission and has been in remission for ≥2 years; low-risk prostate cancer with a Gleason score \<7 and a PSA level \<10 ng/mL; any other cancer from which the subject has been disease-free for ≥3 years * Ongoing systemic infection requiring parenteral treatment * Poorly controlled Type 2 diabetes
Where this trial is running
Gilbert, Arizona and 10 other locations
- Banner MD Anderson — Gilbert, Arizona, United States (Recruiting)
- Stanford Cancer Institute — Stanford, California, United States (Recruiting)
- Emory Winchip Cancer Center — Atlanta, Georgia, United States (Recruiting)
- University of Kansas Clinical Research Center — Westwood, Kansas, United States (Recruiting)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Karmanos Cancer Institute — Detroit, Michigan, United States (Recruiting)
- START Midwest — Grand Rapids, Michigan, United States (Recruiting)
- University of Rochester Medical Center — Rochester, New York, United States (Recruiting)
- University of North Carolina Hospitals at Hillsborough — Chapel Hill, North Carolina, United States (Recruiting)
- Huntsman Cancer Center Institute University of Utah — Salt Lake City, Utah, United States (Recruiting)
- Fred Hutchinson Cancer Center — Seattle, Washington, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.