Safety and Efficacy of Elranatamab Plus Isatuximab, Bortezomib, and Lenalidomide in Ultra-High-Risk Multiple Myeloma

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

This is a prospective, single-arm, single-center interventional study designed to evaluate the safety and efficacy of Elra-Isa-VR in patients with newly diagnosed ultra-high-risk multiple myeloma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The subject voluntarily signs the informed consent form (ICF).

Aged 18-70 years.

Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

Serum M-protein ≥1.0 g/dL

Disqualifiers

Concurrent plasma cell leukemia, central nervous system involvement, or amyloidosis.

Peripheral neuropathy of Grade >1, or Grade 1 peripheral neuropathy with pain. Prior or ongoing systemic therapy or stem cell transplantation for symptomatic multiple myeloma, except for the emergency use of a short course of corticosteroids equivalent to dexamethasone 40 mg/day for 4 days, provided that the course is completed within 14 days before randomization.

Any contraindication to, or a history of life-threatening allergy, hypersensitivity, or intolerance to, any study drug or its excipients.

Pregnant or breastfeeding, or planning to become pregnant during participation in the study or within 6 months after the last dose of any study treatment.

Trial design

Design model

Single group

Treatments tested in this trial

  • anti-BCMA/CD3 bispecific antibody

    Drug

    Anti-BCMA/CD3 bispecific antibody (Elranatamab) will be administered via a subcutaneous injection (SC).

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: BsAbs-treatment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Minimal residual disease (MRD) negativity rate

Time frame
9 months

Secondary outcomes

1

Adverse events and serious adverse events

Time frame
Up to 2 year
2

Sustained MRD negativity rate

Time frame
Up to 2 year
3

Overall response rate (ORR)

Time frame
Up to 2 year
4

Complete response rate (CR)

Time frame
Up to 2 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: