NCT06158841|RecruitingPhase 3DMCFDA Drug

Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma

CERVINO

A Phase 3, Multicenter, Randomized, Open Label Study of Etentamig Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (3L+ RRMM Monotherapy Study)

AbbVie ClinicalTrials.gov

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2 other identifiers

M22-5742023-506668-15-00

Study Type

interventional

Target

380

Locations

24 countries

Sites

159

Timeline

RegisteredDec 2023

StartedMay 2024

CompletionDec 2027

Brief Summary

Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine change in disease symptoms of etentamig compared to standard available therapies in adult participants with relapsed/refractory (R/R) MM. Etentamig is an investigational drug being developed for the treatment of R/R MM. This study is broken into 2 Arms; Arm A and Arm B. In Arm A, participants will receive etentamig as a monotherapy. In Arm B, participants will receive the standard available therapy (SAT) identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. Around 380 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 140 sites across the world. In Arm A participants will receive etentamig as an infusion into the vein in 28 day cycles, during the 3.5 year study duration. In Arm B, participants will receive the SAT identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable, during the 3.5 year study duration. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

380

participants targeted

Target at P50-P75 for phase_3 multiple-myeloma

Timeline

19mo left

Started May 2024

Shorter than P25 for phase_3 multiple-myeloma

Geographic Reach

24 countries

159 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.5 years study duration

Study Progress56%

May 2024Dec 2027

First Submitted

Initial submission to the registry

November 28, 2023

Completed

8 days until next milestone

First Posted

Study publicly available on registry

December 6, 2023

Completed

6 months until next milestone

Study Start

First participant enrolled

May 19, 2024

Completed

3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

3.5 years

First QC Date

November 28, 2023

Last Update Submit

March 11, 2026

Conditions

Multiple Myeloma

Keywords

CervinoMultiple MyelomaEtentamigCarfilzomibPomalidomideElotuzumabSelinexorBortezomibDexamethasone

Outcome Measures

Primary Outcomes (2)

Progression Free Survival (PFS)
PFS is defined as the duration from the date of randomization to the date of confirmed disease progression (PD) determined by independent review committee (IRC) per international myeloma working group (IMWG) (2016) response criteria, or death, whichever occurs first.
Up to Approximately 5 Years
Objective Response Rate (ORR)
ORR is defined as the percentage of participants who achieve confirmed partial response (PR) + VGPR + complete response (CR) + stringent complete response (sCR) or per IRC assessment.
Up to Approximately 5 Years

Secondary Outcomes (19)

Overall Survival (OS)
Up to Approximately 5 Years
Change in Rate of Very Good Partial Response (VGPR) or Better (>= VGPR)
Up to Approximately 5 Years
Change in Rate of CR or Better (>=CR)
Up to Approximately 5 Years
Change in Rate of Minimum Residual Disease (MRD) negativity with >= CR
Up to Approximately 5 Years
Change from Baseline in Disease Symptoms as Measured by the Disease Symptoms Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Multiple Myeloma Module (EORTC QLQ-MY20)
Up to 6 Months
+14 more secondary outcomes

Study Arms (2)

Standard Available Therapy (SAT)

EXPERIMENTAL

Participants will receive SAT, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. SAT choices are carfilzomib + dexamethasone (Kd), elotuzumab + pomalidomide + dexamethasone (EloPd), selinexor + bortezomib + dexamethasone (SVd).

Drug: CarfilzomibDrug: PomalidomideDrug: ElotuzumabDrug: SelinexorDrug: BortezomibDrug: Dexamethasone

Etentamig

EXPERIMENTAL

Participants will receive etentamig as a monotherapy.

Drug: Etentamig

Interventions

EtentamigDRUG

Intravenous (IV) Infusion

Also known as: ABBV-383

Etentamig

CarfilzomibDRUG

IV Infusion