BCMA/CD3 BsAb in the Treatment of High-risk Smoldering Multiple Myeloma (NCT06745687) | Clinical Trial Compass
RecruitingNot Applicable
BCMA/CD3 BsAb in the Treatment of High-risk Smoldering Multiple Myeloma
China20 participantsStarted 2024-12-30
Plain-language summary
The purpose of this study is to evaluate the safety and efficacy of CM-336, which is a BCMA/CD3 BiTE, in the treatment of high risk smoldering multiple myeloma.
Who can participate
Age range
18 Years – 78 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Know and voluntarily sign an informed consent form (ICF).
. Age ≥18 years.
. Definite diagnosis of SMM: According to IMWG Criteria 10, the patient must have histologically or cytologically confirmed smoldering multiple myeloma (SMM), including:
. Serum M protein ≥3 g /dL and/or BMPCs≥10%(but not more than 60%)
. No anemia: hemoglobin ≥10 g /dL
. No renal failure: serum creatinine ≥2.0 mg/dL
. No hypercalcemia: calcium ≥10.5 mg/dL
. dissolving bone lesions without radiographic indications: X-ray, CT, or positron emission tomography (PET)/CT without dissolving bone lesions, with no more than 1 lesion on whole-body MRI (Note: In the investigator's judgment, whole-body CT or PET/CT may replace MRI for patients with contraindications or for whom MRI is not available).
Exclusion criteria
. Diagnosis of symptomatic multiple myeloma: refer to the Chinese Guidelines for Diagnosis and Treatment of multiple myeloma (revised in 2022);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Previously received immunotherapy against BCMA targets.
. The researchers judged that BCMA/CD 3 dual antibody therapy is not suitable, such as severe cardiopulmonary disease and other conditions that are not suitable for BCMA/CD 3 dual antibody therapy.
. Received SMM treatment within six months.
. Known intolerance, allergy or contraindications to BCMA/CD 3 dual anti-active ingredients.
. Patients with unstable or active cardiovascular and cerebrovascular diseases meet any of the following criteria:
. Unstable angina pectoris, symptomatic myocardial ischemia, myocardial infarction, or coronary artery reconstruction had occurred within 180 days prior to initial administration.