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

NCT07789522 | Not Yet Recruiting Phase 2

• 1 other identifier: IIT2026074
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Multiple Myeloma (MM)

Keywords

BCMA/CD3 bispecific antibody; Elranatamab

Outcome Measures

Primary Outcomes (1)

• Minimal residual disease (MRD) negativity rate

  9 months

Secondary Outcomes (6)

• Adverse events and serious adverse events

  Up to 2 year

• Sustained MRD negativity rate

  Up to 2 year

• Overall response rate (ORR)

  Up to 2 year

• Complete response rate (CR)

  Up to 2 year

• Progression-free survival (PFS)

  Up to 2 year

Study Arms (1)

BsAbs-treatment group

EXPERIMENTAL

Drug: anti-BCMA/CD3 bispecific antibody

Interventions

anti-BCMA/CD3 bispecific antibody DRUG

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

BsAbs-treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject voluntarily signs the informed consent form (ICF).
• Aged 18-70 years.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Newly diagnosed multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria, with measurable disease meeting at least one of the following criteria:
• Serum M-protein ≥1.0 g/dL
• Urine M-protein ≥200 mg/24 hours
• Serum involved free light chain ≥10 mg/dL with an abnormal serum free light-chain ratio 4.High-risk multiple myeloma according to the Consensus Genomic Staging (CGS) system published by the International Myeloma Society-International Myeloma Working Group (IMS-IMWG), or peripheral blood plasma cells ≥2%, or an extramedullary soft-tissue mass (EME). High-risk CGS is defined by at least one of the following criteria:
• （1）del(17p) with a clonal fraction \>20% and/or a TP53 mutation （2）An IGH translocation \[t(4;14), t(14;16), or t(14;20)\] combined with 1q+ or del(1p32) （3）del(1p32), defined as monoallelic deletion combined with 1q+ or biallelic deletion （5）β2-microglobulin ≥5.5 mg/L with a normal serum creatinine level

You may not qualify if:

• 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.
• Planning to father a child during participation in the study or within 100 days after the last dose of any component of the study treatment regimen.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Gang An

CONTACT

86-022-23909171; angang@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 9, 2027
• Study Completion (Estimated): October 30, 2028
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share