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Tests treatment safety and results for Multiple Myeloma
Official title A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT07284758
What this study is testing
What is Cemsidomide?
Cemsidomide is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for 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
- This is a Phase 2, open-label, single-arm, multicenter study to assess the antimyeloma activity and further characterize the safety, tolerability, PK, and PD of cemsidomide in combination with dexamethasone in participants with relapsed/refractory multiple myeloma (r/r MM).
- Phase 2: a mid-size study of how well it works
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
- Be willing and able to provide signed informed consent for the study.
- Age ≥ 18 years at the time of signed consent.
- people must have a documented diagnosis of MM and measurable disease at enrollment.
- Received at least 3 prior anti-myeloma regimens (for a minimum of 2 or more consecutive cycles) that must have included an immunomodulatory drug...
- people need to have adequate organ function.
You likely can't join if
- Presence of myeloma in the central nervous system (CNS).
- people with any of the following:
- Systemic light chain amyloidosis
- Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin changes (POEMS) Syndrome
- Myelodysplastic syndrome (MDS).
- Previously treated with cemsidomide.
See the full eligibility criteria
- Be willing and able to provide signed informed consent for the study.
- Age ≥ 18 years at the time of signed consent.
- people must have a documented diagnosis of MM and measurable disease at enrollment.
- Received at least 3 prior anti-myeloma regimens (for a minimum of 2 or more consecutive cycles) that must have included an immunomodulatory drug (i.e., IKZF 1/3 degrader), a proteasome inhibitor, an anti-CD38 antibody...
- people need to have adequate organ function.
- Toxicities from prior anticancer therapies must have resolved to baseline severity or CTCAE ≤ Grade 1.
- Female people may not be pregnant or intend to become pregnant, may not breastfeed or intend to breastfeed, or donate ova during their participation in this study until 30 days after the last dose of study treatment.
- Male people must agree to use a condom when having intercourse with a person of childbearing potential during the Treatment Period and for at least 30 days after the last dose of study treatment.
- Male people must refrain from donating sperm during the Treatment Period and for 30 days after discontinuation.
- people must refrain from donating blood during study treatment and for 30 days after discontinuation.
- Presence of myeloma in the central nervous system (CNS).
- people with any of the following:
- Systemic light chain amyloidosis
- Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin changes (POEMS) Syndrome
- Myelodysplastic syndrome (MDS).
- Previously treated with cemsidomide.
- Clinically significant impaired cardiac function or cardiac disease.
- Thromboembolic event within 3 months prior to enrollment.
- Known malignancy other than study indication that has progressed or required treatment within the past 3 years.
- Uncontrolled active bacterial, fungal, or viral infection.
- Inability or difficulty swallowing tablets. NOTE: Other inclusion/exclusion criteria may apply, per protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- West Hollywood, California, United States
- Atlanta, Georgia, United States
- Indianapolis, Indiana, United States
- Grand Rapids, Michigan, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- San Antonio, Texas, United States
- Madison, Wisconsin, 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 - 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?
Study sites include Scottsdale, Arizona, United States; West Hollywood, California, United States; Atlanta, Georgia, United States; Indianapolis, Indiana, United States; Grand Rapids, Michigan, United States; St Louis, Missouri, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.