Assessing a new treatment for relapsed and refractory multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Banner MD Anderson
  Gilbert, Arizona, United States Recruiting
• UC San Diego Moores Cancer Center
  La Jolla, California, 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Talquetamab combined with iberdomide and dexamethasone for relapsed or refractory multiple myeloma

  This phase 1 trial will test whether adding iberdomide and dexamethasone to talquetamab helps people with relapsed or refractory multiple myeloma who have already received proteasome inhibitors, immunomodulatory drugs, and CD38 antibodies.

  Recruiting Phase 1 University of California, San Francisco · San Francisco, California · NCT06348108

• IDP-023 treatment for advanced blood cancers

  This study is testing a new treatment called IDP-023, which uses special immune cells alone and with other medications to see if it can help people with advanced blood cancers like multiple myeloma and non-Hodgkin lymphoma.

  Recruiting at 9 sites Phase 1/2 Indapta Therapeutics, INC. · Los Angeles, California and 11 other locations · NCT06119685

• Combination therapy for relapsed or refractory multiple myeloma

  This study is testing a new combination of medications to see if it can help people with relapsed or refractory multiple myeloma feel better and improve their treatment results.

  Recruiting Phase 2 University of Miami · Miami, Florida · NCT05896228

• Infliximab to Help Prevent CRS During Teclistamab or Talquetamab Therapy in Relapsed/Refractory Myeloma

  This phase 2 trial tests whether infliximab can prevent cytokine release syndrome in patients with relapsed or refractory multiple myeloma who are being treated with teclistamab or talquetamab.

  Recruiting Phase 2 Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT07657312

• Cognitive training to help brain function in people getting CAR-T therapy for relapsed or refractory blood cancers

  A brain-training program given before and after CAR-T therapy is tested to see if it helps cognitive and neurological outcomes for adults with relapsed or refractory multiple myeloma or B-cell non-Hodgkin lymphoma.

  Recruiting Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT07609030

• Selinexor with Carfilzomib, Isatuximab and Dexamethasone for relapsed or refractory multiple myeloma

  This trial tests whether a four-drug combination can help adults with relapsed or refractory multiple myeloma when they've had at least one prior treatment.

  Recruiting Phase 1/2 Hoosier Cancer Research Network · Madison, Wisconsin · NCT07479979

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.