TerminatedPhase 1/2

A Ph1/2 Study of EMB-06 in Participants With Relapsed or Refractory Myeloma

Stopped: Company's resource optimization and product's development change

Australia, China40 participantsStarted 2021-05-20

Plain-language summary

The primary purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for EMB-06 and to characterize the safety and tolerability of EMB-06 at the RP2Ds. Pharmacokinetics (PK), immunogenicity, and the anti-multiple myeloma activity of EMB-06 will also be assessed.

Who can participate

Age range

18 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.

Exclusion criteria

. Treated with monoclonal antibody for multiple myeloma within 28 days
. Treated with proteasome inhibitors within 14 days
. Treated with immunomodulatory agents within 14 days
. Treated with cytotoxic therapy within 14 days
. Received investigational drug within 28 days or at least 5 half-lives, whichever is shorter (if a, b, c, d not applicable)
. Received radiotherapy within 21 days. Except that the radiation portal covered ≤ 5% of the bone marrow reserve, the patient will be eligible to participate in the study regardless of the end date of radiation therapy
. Plasmapheresis within 7 days

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.

What they're measuring

Incidence and severity of adverse events

Timeframe: Screening up to follow-up (30 days after the last dose)

Incidence of serious adverse events (SAE)

Timeframe: Screening up to follow-up (30 days after the last dose)

Incidence of dose interruptions.

Timeframe: Screening up to follow-up (30 days after the last dose)

Dose intensity

Timeframe: Screening up to follow-up (30 days after the last dose)

The incidence of DLTs during treatment.

Timeframe: First infusion to the end of Cycle 1 (each cycle is 28 days)

Overall Response Rate (ORR)

Timeframe: From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months

Trial details

NCT IDNCT04735575

SponsorShanghai EpimAb Biotherapeutics Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-20

View on ClinicalTrials.gov More Relapsed or Refractory Multiple Myeloma trials

Plain-language summary

Who can participate

Age range

18 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.

Exclusion criteria

. Treated with monoclonal antibody for multiple myeloma within 28 days
. Treated with proteasome inhibitors within 14 days
. Treated with immunomodulatory agents within 14 days
. Treated with cytotoxic therapy within 14 days
. Received investigational drug within 28 days or at least 5 half-lives, whichever is shorter (if a, b, c, d not applicable)
. Received radiotherapy within 21 days. Except that the radiation portal covered ≤ 5% of the bone marrow reserve, the patient will be eligible to participate in the study regardless of the end date of radiation therapy
. Plasmapheresis within 7 days

What they're measuring

Incidence and severity of adverse events

Timeframe: Screening up to follow-up (30 days after the last dose)

Incidence of serious adverse events (SAE)

Timeframe: Screening up to follow-up (30 days after the last dose)

Incidence of dose interruptions.

Timeframe: Screening up to follow-up (30 days after the last dose)

Dose intensity

Timeframe: Screening up to follow-up (30 days after the last dose)

The incidence of DLTs during treatment.

Timeframe: First infusion to the end of Cycle 1 (each cycle is 28 days)

Overall Response Rate (ORR)

Timeframe: From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months