Etenta-Isa-VRd in Newly Diagnosed High-Risk Multiple Myeloma

NCT07600151 | Not Yet Recruiting Phase 1 DMC

• 2 other identifiers: CONQUISTADOR trial2025-523049-83-00
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

This study is researching an experimental five-drug combination called etentamig, isatuximab, bortezomib, lenalidomide, and dexamethasone. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) and high-risk disease who are eligible for autologous stem cell transplantation.

Conditions

Myeloma Multiple; Myeloma

Outcome Measures

Primary Outcomes (3)

• Safety and tolerability (Phase I)

  Number of dose-limiting toxicities (DLTs) in participants and rates of adverse events (AEs) of grade ≥2 and of severe AEs in participants

  through induction treatment, on average 4 months

• MRD negativity (Phase II)

  MRD-negativity rate after 12 cycles (with a sensitivity of \<10-5)

  through consolidation phase completion, an average of 1 year

• PFS

  Progression-free survival

  up to 10 years

Secondary Outcomes (11)

• ORR

  up to 10 years

• CR rate

  up to 10 years

• VGPR Rate

  up to 10 years

• DoR

  up to 10 years

• TTR

  up to 10 years

Study Arms (3)

Dose level 1 (Phase I)

EXPERIMENTAL

First dose level of etentamig to be explored in combination with Isa-VRd

Drug: Etentamig; Drug: Isatuximab; Drug: Bortezomib + Lenalidomide + Dexamethasone

Dose Level 2 (Phase I)

EXPERIMENTAL

Second dose level of etentamig to be explored in combination with Isa-VRd

Drug: Etentamig; Drug: Isatuximab; Drug: Bortezomib + Lenalidomide + Dexamethasone

RP2D in Phase II

EXPERIMENTAL

RP2D of etentamig to be explored in combination with Isa-VRd

Drug: Etentamig; Drug: Isatuximab; Drug: Bortezomib + Lenalidomide + Dexamethasone

Interventions

Etentamig DRUG

Administered per the protocol

Dose Level 2 (Phase I); Dose level 1 (Phase I); RP2D in Phase II

Isatuximab DRUG

Administered per the protocol

Dose Level 2 (Phase I); Dose level 1 (Phase I); RP2D in Phase II

Bortezomib + Lenalidomide + Dexamethasone DRUG

Administered per the protocol

Dose Level 2 (Phase I); Dose level 1 (Phase I); RP2D in Phase II

Eligibility Criteria

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

You may qualify if:

• Participants must have confirmed diagnosis of symptomatic MM per IMWG criteria.
• Participants must have High-risk myeloma according to IMS/IMWG CGS
• Participants must be considered a candidate for high-dose chemotherapy and ASCT, as described in the protocol.
• Participants must have measurable disease as defined in the protocol. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (WHO=3 is allowed only if caused by MM and not by co-morbid conditions).
• Participants must have clinical laboratory values within a prespecified range.

You may not qualify if:

• Known contraindications to the use of any IMP or axMP or required concomitant drugs or supportive treatment.
• known systemic amyloidosis (except for AL amyloidosis of the skin or the bone marrow), POEMS syndrome, Waldenstrom's macroglobulinemia; primary plasma cell leukemia
• Administration of systemic therapy for multiple myeloma except osteoprotective therapy. Emergency myeloma treatment with dexamethasone is allowed according to specifications in the protocol. It is allowed to include patients after 1 cycle of any anti-myeloma first-line treatment within the specifications of the protocol
• known central nervous system involvement by MM.

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• AbbVie: collaborator
• Sanofi: collaborator

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

isatuximab; Bortezomib; Lenalidomide; Dexamethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Katja Weisel

CONTACT

+4940-7410-0; k.weisel@uke.de

Lisa Leypoldt

CONTACT

+4940-7410-0; l.leypoldt@uke.de

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): September 30, 2036
• Study Completion (Estimated): December 31, 2036
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

DE (1)