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Relapse/Refractory Multiple MyelomaPhase 2MARCHNCT03944057

A Study of Evaluating the Safety and Efficacy of ATG-010 in Relapsed Refractory Multiple Myeloma

A Phase 2 study testing ATG-010 in people with Relapse/Refractory Multiple Myeloma, run by Antengene Corporation at 17 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open-label, single-arm study of ATG-010 (selinexor) plus low-dose Dexamethasone (Sd) in patients with multiple myeloma previously treated with lenalidomide and bortezomib refractory to prior treatment with immunomodulatory agents and proteasome Inhibitors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapse/Refractory Multiple Myeloma
What is being tested?
ATG-010
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
17 sitesChina
Study dates
2 Sep 2019to 25 Feb 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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/mm^3
  • Platelet count ≥ 75,000/mm^3 (patients in whom < 50% of bone marrow nucleated cells are plasma cells) or ≥ 50,000/mm^3 (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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

China17 sites

  • Beijing Chao-Yang Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100020

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin, 130021

  • The Third Xiangya Hospital of Central Suoth University

    Changsha, Hunan, 410013

  • Guangdong Provincial Peoples Hospital

    Guangzhou, Guangdong, 510000

  • Nanfang Hospital

    Guangzhou, Guangdong, 510515

  • Sun Yat-Sen University Cancer Center

    Guanzhou, Guangdong, 510060

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • The First Affilate Hospital with Nanjing Medical University

    Nanjing, Jiangsu, 210029

  • Shanghai Changzheng Hospital

    Shanghai, Shanghai Municipality, 200003

  • Shanghai Sixth People's Hospital Affiliate Shanghai JiaoTong University

    Shanghai, Shanghai Municipality, 200233

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

  • Tianjin blood research institute

    Tianjin, Tianjin Municipality, 300020

  • Xijing Hospital

    Xi’an, Shanxi, 710032

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

Other trials in China

About this study

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

This is an open-label, single-arm study of ATG-010 (selinexor) plus low-dose Dexamethasone (Sd) in patients with multiple myeloma previously treated with lenalidomide and bortezomib refractory to prior treatment with immunomodulatory agents and proteasome Inhibitors.

Read the detailed description

This is a single-arm, open-label, multicenter study of ATG-010 (Selinexor) plus low dose Dexamethasone dosed twice weekly each week in four-week cycles, in patients with triple-refractory MM. The population refractory for the primary efficacy analysis will contain only patients with triple-MM enrolled. PK analysis would be performed which would contain approximately 30% of the patients enrolled. Safety analyses will be performed on the overall population of patients who received at least one dose of study drug among triple-refractory patient populations. Patients will receive treatment until progressive disease (PD), death, toxicity that cannot be managed by standard care, or withdrawal, whichever occurs first.

Being tested
ATG-010
Medical subject headings
Recurrence, Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ATG-010Drug

    Also called Selinexor

    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)

Study groups in NCT03944057
Study groupRoleWhat they receive
ATG-010 + DexamethasoneExperimentalOpen-label ATG-010 80mg plus Dexamethasone 20 mg
Receives: Drug: ATG-010

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (ORR)

    The primary efficacy endpoint of ORR consists of proportion of patients who achieve PR, VGPR, CR, or sCR according to IMWG 2016 criteria:

    • CR means Negative IFE of serum and urine, disappearance of any soft tissue plasmacytomas (SPD), and <5% plasma cells in bone marrow aspirates;
    • sCR means CR as defined above plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry (κ/λ ratio ≤ 4:1 or ≥ 1:2 for κ and λ patients, respectively, after counting ≥ 100 plasma cells);
    • VGPR means Serum and urine M-protein detectable by IFE but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours;
    • PR means ≥50% reduction of serum M-protein plus reduction in 24-hour urine M-protein by ≥90% or to <200 mg per 24 hours. If the serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria.

    Measured: 12 months

Secondary outcomes (1)

  1. Progression-Free Survival (PFS)

    To evaluate progression-free survival

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2019
  2. Study start2 Sep 2019
  3. Primary completion25 Feb 2022
  4. Study completion25 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03944057
Sponsor's protocol ID
ATG-010-MM-001
Acronym
MARCH
Status last verified
May 2023
First submitted
30 Apr 2019
Last updated
15 Jun 2023
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Qiu L, Xia Z, Fu C, Chen W, Chang C, Fang B, An G, Wei Y, Cai Z, Gao S, Weng J, Chen L, Jing H, Li F, Liu Z, Chen X, Liu J, Wang A, Yu Y, Xiang W, Lynch K, Yu Z, Fu W. Selinexor plus low-dose dexamethasone in Chinese patients with relapsed/refractory multiple myeloma previously treated with an immunomodulatory agent and a proteasome inhibitor (MARCH): a phase II, single-arm study. BMC Med. 2022 Apr 5;20(1):108. doi: 10.1186/s12916-022-02305-4.

    PubMed 35379237

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ATG-010 in people with Relapse/Refractory Multiple Myeloma, run by Antengene Corporation at 17 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03944057, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.

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