Trials Sponsors Conditions Drugs Pricing

Conditions

Amyloidosis Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

Dose limiting toxicity
DLT will be defined based on the rate of drug-related grade 3-5 adverse events experienced within the first 6 weeks (2 cycles) of study treatment. These will be assessed via CTCAE version 5.0
28 days

Study Arms (2)

APG-2575 +Pd or LD

EXPERIMENTAL

APG-2575+ Pomalidomide 4mg QD x 21 days + dexamethasone

Drug: APG-2575+ Pd

APG-2575+LD

EXPERIMENTAL

APG-2575+ Lenalidomide +Dexa Days 1 through 21 of each 28-day cycle,

Drug: APG-2575 + DRd

Interventions

APG-2575+ PdDrug

APG-2575 + Pomalidomide 4mg QD x 21 days + dexamethasone (40 mg for patients ≤ 75 years old or 20 mg for patients \> 75 years old) on Days 1, 8, 15, and 22 of a repeated 28-day cycle

Also known as: APG-2575+ Pomalidomide + Dexamethasone

APG-2575 +Pd or LD

APG-2575 + DRdDrug

APG-2575+ Lenalidomide administered at a dose of 25 mg orally (PO) on Days 1 through 21 of each 28-day cycle, dexamethasone will be administered at a dose of 40 mg (or 20 mg for patients \> 75 years old) once weekly, and daratumumab will be administered intravenously at a dose of 16 mg/kg (or 1800 mg administered subcutaneously if commercially available) weekly in cycles 1 and 2 and then every 2 weeks in cycles 3 to 6 and every 4 weeks thereafter.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

≥ 18 years of age
MM patients (for Arm A and Arm B): Patients with Relapsed/Refractory MM per 2016 IMWG criteria, previously treated with at least 1 but not more than 4 prior lines of therapy for MM. Refractory MM, meanwhile, is defined as disease that progresses on salvage therapy or progresses within 60 days of the last treatment.

Sponsors & Collaborators

Ascentage Pharma Group Inc.
Industrylead

Study Sites (3)

Mayo Clinic

Jacksonville, Florida, 32224, United States

RECRUITING

Weil Cornell Medical Center

New York, New York, 10065, United States

RECRUITING

Cleveland Clinic Hosptials

Cleveland, Ohio, 44103, United States

RECRUITING

MeSH Terms

Conditions

Multiple MyelomaAmyloidosis

Interventions

DexamethasoneLisaftoclaxGTP Cyclohydrolase

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic Diseases

Study Officials

Yifan Zhai, MD, PhD
Ascentage Pharma Group Inc.
STUDY CHAIR

Central Study Contacts

Angela Kaiser

CONTACT

301-509-0357 angela.kaiser@ascentage.com

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 29, 2020

First Posted

June 28, 2021

Study Start

December 23, 2021

Actual (reported)

Primary Completion

September 1, 2024

You may not qualify if:

MM patients with newly diagnosed MM, previously untreated for MM or only had been treated with localized palliative treatment or steroids less than equivalent of dexamethasone 40 mg daily for 4 days). AL amyloidosis patients with AL amyloidosis have not been treated with any systemic therapy, or AL amyloidosis clinically overt multiple myeloma i.e. original CRAB criteria. Extent of marrow plasmacytosis is not prohibitive.
Subject has received antineoplastic therapy within 2 weeks before the date of initiating study treatment
Subject has previously received an allogenic stem cell transplant (regardless of timing)
Subjects planning to undergo a stem cell transplant prior to progression of disease on this study, i.e., these subjects should not be enrolled in order to reduce disease burden prior to transplant.
BCL-2-directed therapy within 4 weeks of initiating study treatment. (BCL-2 directed therapy more than 4 weeks before initiation of study treatment is allowed).
For Arm A/C only: The subjects show evidence of intolerance to pomalidomide, which is defined as subjects discontinued due to any AEs related to prior pomalidomide treatment
For Arm B only: The subjects show evidence of intolerance to daratumumab or lenalidomide, which is defined as subjects discontinued due to any AEs related to prior daratumumab or lenalidomide treatment
Patients with any uncontrolled active systemic infection, including but not limited to active hepatitis B or C virus infection, known human immunodeficiency virus (HIV) positive
Subject has peripheral neuropathy ≥grade 3 except caused by AL amyloidosis
Subject has plasma cell leukemia (\>2.0\*10\^9/L circulating plasma cells by standard differential) or Waldenström's macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
Plasmapheresis \<35 days prior to the initiation of study drug
Failure to have fully recovered (i.e., ≤ Grade 1 toxicity) from the reversible effects of prior treatment for MM or AL amyloidosis
Unable to swallow tablets or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction
Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia (including Frederica corrected QT interval (QTc) ≥470 msec ) or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to initiating study treatment
Major surgical procedure within ≤14 days prior to initiating study treatment, or anticipation of the need for major surgery during the course of the study treatment, radiotherapy ≤14 days prior to initiating study treatment, systemic treatment within 14 days before the first dose of APG-2575
+7 more criteria

APG-2575 in Combination With Novel Therapeutic Regimens in Subjects With Relapsed or Refractory Multiple Myeloma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

APG-2575 +Pd or LD

APG-2575+LD

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

APG-2575 +Pd or LD

APG-2575+LD

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations