Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Disease Progression

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Real-world (RW) patients with RRMM who have either at least three prior lines of therapy (LOT) and are triple-class exposed (3L+/TCE), or are triple-class refractory (TCR), meet similar inclusion/exclusion criteria used to establish phase 2 cohort 2 of the R5458-ONC-1826 trial, and are initiating currently available therapies.

No study treatment will be administered on this study.

Non-Interventional

Clinical Trial Management

Primary Objective:

1. To describe the distribution of treatment regimens and objective response rate (ORR) in a Benchmark Cohort of real-world patients with relapsed/refractory multiple myeloma (RRMM) who initiate treatment after meeting the following criteria: (1) have either (a) at least three prior lines (3L) and are triple-class exposed (TCE), or (b) are triple-class refractory (TCR), and (2) meet similar inclusion/exclusion criteria to patients in phase 2 cohort 2 of the R5458-ONC-1826 (NCT03761108) trial.

Secondary Objectives:

1. To describe additional outcomes (duration of response \[DOR\], progression-free survival \[PFS\], overall survival \[OS\], and time to next treatment \[TTNT\]) in the same Benchmark Cohort population described in the primary objective.
2. To describe distribution of treatment regimens, ORR, DOR, PFS, OS, and to compare ORR, PFS, OS, and TTNT in an Analysis Cohort consisting of real-world patients derived from the Benchmark Cohort described above who are weighted to align with the characteristics of patients in phase 2 cohort 2 of the R5458-ONC-1826 (NCT03761108) trial. Comparative analyses of PFS and OS will be performed conditional on sufficient maturity of survival data in the R5458-ONC-1826 (NCT03761108) trial at the time of analysis.

Real-World Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma

A Study to Characterize Treatment Patterns and Real-World Outcomes in Heavily Pretreated Patients With Relapsed and Refractory Multiple Myeloma (RRMM) and Similar Clinical Characteristics to Patients in the Phase 2 Cohort 2 of the R5458-ONC-1826 Trial

Defined as stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR)

Defined as time from the date of the first documented response (best overall response of sCR, CR, VGPR, PR) until the first date of progressive disease (PD) by International Myeloma Working Group (IMWG) or death due to any cause, whichever occurs first.

Defined as time from the start of study treatment until the first date of PD by IMWG, or death due to any cause, whichever occurs first.

OS is measured from the start of study treatment until death due to any cause.

Defined as time from the start of study treatment until the initiation of the subsequent LOT.

Regeneron Pharmaceuticals

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Lenvatinib

Chlorotrianisene

Protein Kinase Inhibitors

Enzyme Inhibitors

Envafolimab, Lenvatinib Combined With TACE

TACE lays a theoretical foundation for synergistic enhancement in combination with PD-1/PD-L1 immunosuppressive agents by reducing tumor burden and peripheral blood treg, improving the immune status of patients, reducing immune tolerance, and enhancing anti-tumor effects. TACE then causes locally treated tumor cell death and releases tumor-specific antigens, which further induce tumor-associated antigen-specific responses due to this immunogenic cell death (ICD), thereby activating the immune system to attack tumor cells.

This is a single-arm, open-label, exploratory clinical study to evaluate the efficacy and safety of Envafolimab, Lenvatinib combined with TACE in the treatment of unresectable locally advanced hepatocellular carcinoma.

Envafolimab, Lenvatinib Combined With TACE in the Treatment of Unresectable Locally Advanced Hepatocellular Carcinoma

A Single-arm, Open-label, Prospective, Phase II Clinical Study of Envafolimab, Lenvatinib Combined With TACE in the Treatment of Unresectable Locally Advanced Hepatocellular Carcinoma

Refers to the proportion of patients who achieve a pre-specified reduction in tumor size and maintain the minimum time limit

Time from randomization to death from any cause (for subjects who were lost to follow-up prior to death, the time of last follow-up was generally calculated as the time of death)

Time to first occurrence of disease progression or death from any cause at randomization

Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Real-World Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma	NCT05673967	Relapsed and Re...	Non-Interventio...	18 Years -	Regeneron Pharmaceuticals
Envafolimab, Lenvatinib Combined With TACE in the Treatment of Unresectable Locally Advanced Hepatocellular Carcinoma	NCT05582109	Objective Respo...	Envafolimab, Le...	18 Years -	Tianjin Medical University Cancer Institute and Hospital

Spots Global Cancer Trial Database for objective response rate (orr)