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New treatment option for Multiple Myeloma
Official title Mezigdomide (CC-92480) Post Idecabtagene Vicleucel in Treating Patients With Relapsed Multiple Myeloma
ClinicalTrials.gov ID: NCT06048250
What this study is testing
What is Mezigdomide?
Mezigdomide is an investigational medicine, given as a monthly infusion into a vein, being studied as a potential treatment for multiple myeloma.
Also referred to as BMS 986348, BMS-986348.
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 phase I trial studies the safety, side effects, best dose and effectiveness of mezigdomide (CC-92480) when given after idecabtagene vicleucel (Abecma chimeric antigen receptor [CAR] T-cell therapy) in patients with multiple myeloma that has come back after a period of improvement (relapsed). CC-92480 works by binding to a protein called CRBN that triggers the breakdown of proteins: Ikaros and Aiolos, leading to cell death in multiple myeloma cells.
- Phase 1: an early, usually small safety study
- Time commitment: about 2 years
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
- Documented informed consent of the participant and/or legally authorized representative.
- Assent, when appropriate, will be obtained per institutional guidelines
- Age: \>= 18 years
- Eastern Cooperative Oncology Group (ECOG) =\< 2
- Diagnosis of multiple myeloma
You likely can't join if
- Prior exposure to mezigdomide (CC-92480)
- Current or planned use of other therapies other than mezigdomide (CC-92480)
- Patients who are currently receiving or likely to require systemic immunosuppressive therapy. Physiologic replacement of steroids (=\< 5.0 mg/day...
- Concomitant use of CYP3A4/5 inhibitors and inducers
- Concomitant use of proton pump inhibitors
- Evidence of relapse as evaluated by the treating physician or study investigator
See the full eligibility criteria
- Documented informed consent of the participant and/or legally authorized representative.
- Assent, when appropriate, will be obtained per institutional guidelines
- Age: \>= 18 years
- Eastern Cooperative Oncology Group (ECOG) =\< 2
- Diagnosis of multiple myeloma
- Subject must have received at least 4 prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody
- Receipt of commercially available idecabtagene vicleucel (Abecma) according to FDA approved US Prescribing Information. Note: Patients who received non-conforming Abecma who were originally prescribed Abecma according...
- Subject must have experienced at least a stable disease in response to idecabtagene vicleucel
- Fully recovered from the acute toxic effects (except alopecia) to =\< grade 1 to prior anti-cancer therapy, including idecabtagene vicleucel
- Absolute neutrophil count (ANC) \>= 1,500/mm\^3 without the use of filgrastim in the previous 3 days (To be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)
- Two repeat tests are allowed. If the repeat test satisfies criteria, the participant may enroll provided all other criteria are met
- Platelets \>= 75,000/mm\^3 without platelet transfusion in the previous 3 days. (To be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)
- Two repeat tests are allowed. If the repeat test satisfies criteria, the participant may enroll provided all other criteria are met
- Total bilirubin =\< 1.5 X upper limit of normal (ULN) (unless has known Gilbert's disease) (To be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated).
- Two repeat tests are allowed. If the repeat test satisfies criteria, the participant may enroll provided all other criteria are met
- Aspartate aminotransferase (AST) =\< 3 x ULN (To be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated).
- Two repeat tests are allowed. If the repeat test satisfies criteria, the participant may enroll provided all other criteria are met
- Alanine transaminase (ALT) =\< 3 x ULN (To be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated).
- Two repeat tests are allowed. If the repeat test satisfies criteria, the participant may enroll provided all other criteria are met
- Alkaline phosphatase =\< 5 x ULN (To be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)
- Creatinine clearance of \>= 50 mL/min per 24 hour urine test or the Cockcroft-Gault formula (To be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated).
- Two repeat tests are allowed. If the repeat test satisfies criteria, the participant may enroll provided all other criteria are met
- Oxygen saturation \> 92% on room air (To be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)
- Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required (To be performed within 14 days...
- Agreement by females of childbearing potential and males to follow the guidelines of the mezigdomide (CC-92480) pregnancy prevention plan
- Prior exposure to mezigdomide (CC-92480)
- Current or planned use of other therapies other than mezigdomide (CC-92480)
- Patients who are currently receiving or likely to require systemic immunosuppressive therapy. Physiologic replacement of steroids (=\< 5.0 mg/day prednisone or equivalent) is allowed
- Concomitant use of CYP3A4/5 inhibitors and inducers
- Concomitant use of proton pump inhibitors
- Evidence of relapse as evaluated by the treating physician or study investigator
- Active central nervous system involvement
- Ongoing toxicities associated with cytokine release syndrome (CRS) or Immune effector cell-associated neurotoxicity syndrome (ICANS) from CAR T cell therapy
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
- Coronavirus disease 2019 (COVID-19) positive, as assessed by a polymerase chain reaction (PCR) test or active uncontrolled infections (defined as active antibiotic use within 7 days of starting the investigational drug)
- If human immunodeficiency virus (HIV) positive: CD4+ T cell count \< 200
- Females only: Pregnant or breastfeeding
- Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, 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 study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Duarte, California, United States. 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.