Relapsed Multiple Myeloma study: OPN-6602 vs Dexamethasone
Official title Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT06433947
What this study is testing
What is OPN-6602?
OPN-6602 is an investigational oral medicine being studied for relapsed multiple myeloma.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will look at how safe and well tolerated OPN-6602 is, how it behaves in the body, and whether it shows any early signs of fighting the cancer.
- Who it's for
- Adults with relapsed or refractory multiple myeloma who have already tried other treatments.
- What's involved
- Participants will receive OPN-6602 alone or with dexamethasone, and will have blood tests and other safety checks during the study.
- Time commitment
- The study lasts several months, with regular clinic visits for medication, blood draws, and safety monitoring.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Adequate hematologic, renal, liver, cardiac function
You likely can't join if
- 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
See the full eligibility 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...
- Adequate hematologic, renal, liver, cardiac function
- 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; people 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 people 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
- Ongoing systemic infection requiring parenteral treatment
- Poorly controlled Type 2 diabetes
The study team makes the final eligibility decision.
Where it is enrolling
- Gilbert, Arizona, United States
- La Jolla, California, United States
- Stanford, California, United States
- Atlanta, Georgia, United States
- Westwood, Kansas, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Grand Rapids, Michigan, United States
- Rochester, New York, United States
- Chapel Hill, North Carolina, United States
- Salt Lake City, Utah, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Gilbert, Arizona, United States; La Jolla, California, United States; Stanford, California, United States; Atlanta, Georgia, United States; Westwood, Kansas, United States; Boston, Massachusetts, United States and 6 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.