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NCT07789522Not yet recruitingPhase 2

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

A Clinical Study Evaluating the Safety and Efficacy of Elranatamab in Combination With Isatuximab, Bortezomib, and Lenalidomide in Patients With Ultra-High-Risk Multiple Myeloma.

Source: ClinicalTrials.gov · Last updated 27 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
15 (estimated)
First submitted
24 Aug 2026
Start date
1 Oct 2026
Primary completion date
9 Oct 2027
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
NCT number
NCT07789522

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 15
  • From 1 Oct 2026 to the primary completion date, 9 Oct 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

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

Other

  • 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.

Who the study is looking for

  • 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

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.