Recruiting NCT06158841

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

Phase III Interventional Multiple Myeloma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Etentamig, Carfilzomib, Pomalidomide, Elotuzumab.
Who it may be relevant to: Registry conditions: Multiple Myeloma. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Austria, Belgium, Canada +20
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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.

Interventions

Drug Etentamig
Intravenous (IV) Infusion
Drug Carfilzomib
IV Infusion
Drug Pomalidomide
Oral Capsule
Drug Elotuzumab
IV Infusion
Drug Selinexor
Oral Tablet
Drug Bortezomib
Subcutaneous or IV Injection
Drug Dexamethasone
Oral Tablet or IV Infusion

Primary outcome measures

Progression Free Survival (PFS) [Time frame: Up to Approximately 5 Years]
Objective Response Rate (ORR) [Time frame: Up to Approximately 5 Years]

Secondary outcome measures (12)

Overall Survival (OS) [Time frame: Up to Approximately 5 Years]
Change in Rate of Very Good Partial Response (VGPR) or Better (>= VGPR) [Time frame: Up to Approximately 5 Years]
Change in Rate of CR or Better (>=CR) [Time frame: Up to Approximately 5 Years]
Change in Rate of Minimum Residual Disease (MRD) negativity with >= CR [Time frame: 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) [Time frame: Up to 6 Months]
Change from Baseline in Physical Functioning as Measured by the Physical Functioning Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) [Time frame: Up to 6 Months]
Time to Response (TTR) [Time frame: Up to Approximately 5 Years]
Duration of Response (DOR) [Time frame: Up to Approximately 5 Years]
Time-to-Progression (TTP) [Time frame: Up to Approximately 5 Years]
Time to Next Anti-lymphoma Therapy (TTNT) [Time frame: Up to Approximately 5 Years]
Number of Participants with Event-free Survival (EFS) [Time frame: Up to Approximately 5 Years]
Change from Baseline in Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a (PROMIS Fatigue SF 7a) [Time frame: Up to Approximately 6 Months]

Eligibility criteria

Inclusion criteria

Eastern Cooperative Oncology Group (ECOG) performance of <= 2.
Diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) during or after the participant's last treatment as stated in the protocol.
Must have measurable disease with at least 1 of the following assessed within 28 days of enrollment:

Serum M-protein >= 0.5 g/dL (>= 5 g/L).
Urine M-protein >= 200 mg/24 hours.
In participants without measurable serum or urine M protein, serum free light chain (FLC) >= 100 mg/L (10 mg/dL) (involved light chain)and an abnormal serum kappa lambda ratio.
Must have received at least 2 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide (IMiD), and an anti-CD38 monoclonal antibody (mAb).

\-- US and Puerto Rico only: Participant must have received at least 1 or more line of therapy, including exposure to a PI, an IMiD, and an anti-CD38 mAb.

Must be eligible to receive the Investigator's choice standard available therapy (SAT) based on approved prescribing information, previous MM treatment history, and institutional guidelines.

Exclusion criteria

Clinically significant (per Investigator's judgment) drug or alcohol abuse within the last 6 months.
Clinically significant conditions such as but not limited to the following: neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months that would adversely affect the participant's participation in the study.
Central nervous system involvement of MM.
Has received B-cell maturation antigen (BCMA)-targeted therapy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment

Study locations

United States · 46 centers

University of Alabama at Birmingham - Main /ID# 261434 — Birmingham
Mayo Clinic Hospital - Phoenix /ID# 263326 — Phoenix
Alta Bates Summit Medical Center for Research /ID# 261438 — Berkeley
Providence - St. Jude Medical Center /ID# 262031 — Fullerton
VA Loma Linda Healthcare System /ID# 261015 — Loma Linda
Cedars-Sinai Medical Center /ID# 261008 — Los Angeles
Rocky Mountain Cancer Centers - Lone Tree /ID# 278320 — Lone Tree
Mayo Clinic Hospital Jacksonville /ID# 263324 — Jacksonville
… and 38 more centers

China · 18 centers

Beijing Chaoyang Hospital,Capital Medical University /ID# 245533 — Beijing
Peking Union Medical College Hospital East - Dongdan Campus /ID# 245545 — Beijing
Fujian Medical University Union Hospital /ID# 245558 — Fuzhou
Sun Yat-Sen University Cancer Center /ID# 245542 — Guangzhou
People's Hospital of Henan Province /ID# 260918 — Zhengzhou
Henan Cancer Hospital /ID# 245536 — Zhengzhou
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 2455 — Wuhan
Zhongda Hospital Southeast University /ID# 245563 — Nanjing
… and 10 more centers

Japan · 17 centers