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New treatment option for Relapsed Refractory Multiple Myeloma (RRMM)
Official title Mezigdomide and Elranatamab for Relapsed and/or Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT06645678
What this study is testing
What is Elranatamab?
Elranatamab is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for relapsed refractory multiple myeloma (rrmm).
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 goal of this clinical trial is to find out how well a combination of two medicines (mezigdomide and elranatamab) works in treating patients with refractory/relapsed multiple myeloma.
- 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 19 and older
You may be able to join if
- people must satisfy the following criteria to be enrolled in the study:
- Subject is ≥ 19 years of age at the time of signing the informed consent form (ICF). ② Subject must understand and voluntarily sign an ICF prior to...
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements. ④ Subject has documented diagnosis of MM and...
- Subject must have documented disease progression during or after their last antimyeloma regimen. ⑨ Subject has an Eastern Cooperative Oncology Group...
- True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (e.g., calendar...
You likely can't join if
- The presence of any of the following will exclude a subject from enrollment:
- 1 Subject who has had prior treatment with mezigdomide. 2 Patients with gastrointestinal disease or surgery (eg, gastric bypass surgery) that may...
See the full eligibility criteria
- people must satisfy the following criteria to be enrolled in the study:
- Subject is ≥ 19 years of age at the time of signing the informed consent form (ICF). ② Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements. ④ Subject has documented diagnosis of MM and measurable disease, defined as any of the following: A. M-protein ≥ 0.5...
- Subject must have documented disease progression during or after their last antimyeloma regimen. ⑨ Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2. ⑩ Individual of...
- True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (e.g., calendar, ovulation, post-ovulation methods) and withdrawal are not acceptable...
- Male people must agree to refrain from donating sperm while on study treatment, during dose interruptions and for at least 28 days following last dose of mezigdomide,
- Females must agree to refrain from donating eggs while on study treatment and for at least 28 days after last dose of mezigdomide.
- people must agree to refrain from donating blood while on study treatment, during dose interruptions and for at least 28 days following the last dose of mezigdomide.
- people must agree to refrain from receiving live vaccines while on study treatment, during dose interruptions and for at least 90 days following the last dose of the study treatment.
- The presence of any of the following will exclude a subject from enrollment:
- 1 Subject who has had prior treatment with mezigdomide. 2 Patients with gastrointestinal disease or surgery (eg, gastric bypass surgery) that may significantly alter the absorption of mezigdomide and/or other oral study...
The study team makes the final eligibility decision.
Where it's taking place
- Singapore, Singapore
- Hwasun, South Korea
- Seoul, South Korea
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, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore, Singapore; Hwasun, South Korea; Seoul, South Korea. 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.