Recruiting NCT07284758
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cemsidomide, Dexamethasone.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma, Relapsed/Refractory Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma
Overview
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).
Interventions
- Drug Cemsidomide
dosed orally (PO) once a day (QD) 14 days on/14 days off for each 28-day cycle - Drug Dexamethasone
dosed PO once a week (QW) on Days 1, 8, 15, and 22 for each 28-day cycle
Primary outcome measures
- Overall response rate (ORR) per International Myeloma Working Group (IMWG) Response Criteria by an Independent Review Committee (IRC) [Time frame: up to approximately 43 months]
Secondary outcome measures (7)
- Duration of response (DoR; IRC assessed) [Time frame: up to approximately 43 months]
- Complete response (CR) rate (IRC assessed) [Time frame: up to approximately 43 months]
- Time to response (IRC assessed) [Time frame: up to approximately 43 months]
- Progression free survival (PFS; IRC assessed) [Time frame: up to approximately 43 months]
- Overall survival (OS) [Time frame: up to approximately 43 months]
- Adverse events (AEs); serious AEs (SAEs); AEs leading to treatment interruption, reduction, or discontinuation; and deaths [Time frame: within 30 to 35 days of the last dose of study treatment]
- Plasma concentrations of cemsidomide [Time frame: up to approximately 4 months]
Eligibility criteria
Inclusion criteria
- Be willing and able to provide signed informed consent for the study.
- Age ≥ 18 years at the time of signed consent.
- Subjects 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, and a T-cell engager (TCE) or chimeric antigen receptor T-cell (CAR-T) therapy, unless not available per local standard of care.
- Subjects need to have adequate organ function.
- Toxicities from prior anticancer therapies must have resolved to baseline severity or CTCAE ≤ Grade 1.
- Female subjects 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 subjects 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 subjects must refrain from donating sperm during the Treatment Period and for 30 days after discontinuation.
- Subjects must refrain from donating blood during study treatment and for 30 days after discontinuation.
Exclusion criteria
- Presence of myeloma in the central nervous system (CNS).
- Subjects 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 20 centers
- Clearview Cancer Institute — Huntsville
- Mayo Clinic - Arizona — Phoenix
- HonorHealth — Scottsdale
- Berenson Cancer Center — West Hollywood
- Mayo Clinic - Florida — Jacksonville
- Winship Cancer Institute, Emory University — Atlanta
- Indiana University Health — Indianapolis
- University of Iowa — Iowa City
- … and 12 more centers
United Kingdom · 1 center
- Imperial College Healthcare NHS Foundation Trust - Hammersmith Hospital — London
Identifiers
NCT: NCT07284758 · CFT7455-2101