A Study of Evaluating the Safety and Efficacy of ATG-010 in Relapsed Refractory Multiple Myeloma (MARCH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03944057|
Recruitment Status : Completed
First Posted : May 9, 2019
Last Update Posted : July 28, 2022
- Study Details
- Tabular View
- Results Submitted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Relapse/Refractory Multiple Myeloma||Drug: ATG-010||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Single-Arm Study of ATG-010 Plus Dexamethasone in Patients With Multiple Myeloma Refractory to Prior Treatment With Immunomodulatory Agents and Proteasome Inhibitor|
|Actual Study Start Date :||September 2, 2019|
|Actual Primary Completion Date :||February 25, 2022|
|Actual Study Completion Date :||February 25, 2022|
Experimental: ATG-010 + Dexamethasone
Open-label ATG-010 80mg plus Dexamethasone 20 mg
ATG-010 (Selinexor) will be given at an oral fixed milligram (mg) dose of 80 mg twice weekly each week for four-week cycles (total of 8 ATG-010 doses per cycle).
Dexamethasone 20 mg will be given with each dose of ATG-010 (Selinexor)
Other Name: Selinexor
- Overall Response Rate (ORR) [ Time Frame: 12 months ]To determine the overall response rate according to IMWG 2016 criteria
- Survival Rate (SR) [ Time Frame: 12 months ]To evaluate survival rate at 6 months, 9 months, 12 months
- Time To Progression (TTP) [ Time Frame: 12 months ]To evaluate duration from initiation of treatment to disease progression
- Progression-Free Survival (PFS) [ Time Frame: 12 months ]To evaluate progression-free survival
- Duration of Response (DOR) [ Time Frame: 12 months ]To evaluate duration of response
- Clinical Benefit Rate (CBR) [ Time Frame: 12 months ]Clinical Benefit Rate (CBR=ORR+Minor Response [MR])
- Disease Control Rate (DCR) [ Time Frame: 12 months ]Disease Control Rate (DCR=CBR+Stable Disease[SD])
- Overall Survival (OS) [ Time Frame: 12 months ]The estimates of Kaplan-Meier
- Minimal Residual Disease (MRD) [ Time Frame: 12 months ]To evaluate the minimal residual disease in CR and sCR patients
- The incidence of treatment emergent adverse events (TEAEs) & SAE assessed by CTCAE v4.03 [ Time Frame: 12 months ]The treatment emergent adverse events (TEAEs) & SAE case No. in total subject No.
- Peak Plasma Concentration (Cmax) [ Time Frame: 12 months ]To evaluate the maximum plasma concentration (Cmax) of ATG-010 in Chinese patient population
- Peak Plasma Concentration（Tmax） [ Time Frame: 12 months ]To evaluate the time to reach Cmax of ATG-010 in Chinese patient population
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Written informed consent in accordance with federal, local, and institutional guidelines.
- Age ≥ 18 years at the time of signing informed consent.
- Patients must have previously received including proteasome inhibitors (PI) (i.e., lenalidomide) and immunomodulatory drugs (i.e., bortezomib) and were refractory to both drugs.
- Any clinically significant non-hematological toxicities (except for peripheral neuropathy as described in exclusion criterion #17) that patients experienced from treatments in previous clinical studies must have resolved to Grade ≤ 2 by Cycle 1 Day 1.
- Adequate hepatic function within 21 days prior to Cycle 1 Day 1: total bilirubin < 2x upper limit of normal (ULN) (except patients with Gilbert's syndrome who must have a total bilirubin of < 3x ULN), AST < 2.5x ULN and ALT < 2.5x ULN.
- Adequate renal function within 21 days prior to Cycle 1 Day 1: estimated creatinine clearance of ≥ 20 mL/min, calculated using the formula of cockroft and gault.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
- Measurable MM based on IMWG guidelines.
Adequate hematopoietic function within 21 days prior to Cycle 1 Day 1 (See Exclusion Criterion #20 for transfusion washout periods for RBCs and platelets):
- Hemoglobin level ≥ 8.5 g/dL
- ANC ≥ 1000/mm3
- Platelet count ≥ 75,000/mm3 (patients in whom < 50% of bone marrow nucleated cells are plasma cells) or ≥ 50,000/mm3 (patients in whom ≥ 50% of bone marrow nucleated cells are plasma cells. [Platelet transfusions < 1 week prior to Cycle 1 Day 1 are prohibited (see below).]
Female subjects of child-bearing potential must have both of the following:
- Agree to the use of two study physician-approved contraceptive methods simultaneously, or practice complete abstinence starting at the time of ICF signature, while on study medication, and 3 months following the last dose of study drug.
- Have negative serum pregnancy test result at screening.
The presence of any of the following will exclude a subject from enrollment:
- Active smoldering MM.
- Active plasma cell leukemia.
- Documented systemic amyloid light chain amyloidosis.
- Active central nervous system (CNS) MM.
- Pregnancy or breastfeeding.
- Chemotherapy ≤ 4 week, radiation and immunotherapy ≤ 4 weeks prior to Cycle 1 Day 1, and radio-immunotherapy 6 weeks prior to Cycle 1 Day 1.
- Active graft vs. host disease (after allogeneic stem cell transplantation) at Cycle 1 Day 1
- Life expectancy of < 4 months.
- Major surgery within four weeks prior to Cycle 1 Day 1.
Active, unstable cardiovascular function:
- Symptomatic ischemia, or
- Uncontrolled clinically-significant conduction abnormalities (e.g., patients with ventricular tachycardia on antiarrhythmics are excluded; patients with 1st degree atrioventricular (AV) block or asymptomatic left anterior fascicular block/right bundle branch block (LAFB/RBBB) will not be excluded), or
- Congestive heart failure (CHF) of New York Heart Association (NYHA) Class ≥ 3, or
- Myocardial infarction (MI) within 3 months prior to Cycle 1 Day 1.
- Prior exposure to a SINE compound, including ATG-010.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03944057
|Study Director:||Ying Jiao, MD||Medical Monitor|
|Responsible Party:||Antengene Corporation|
|Other Study ID Numbers:||
|First Posted:||May 9, 2019 Key Record Dates|
|Last Update Posted:||July 28, 2022|
|Last Verified:||July 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases