Trial Outcomes & Findings for A Study of Evaluating the Safety and Efficacy of ATG-010 in Relapsed Refractory Multiple Myeloma (NCT NCT03944057)

Last Updated: 2023-06-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

82 participants

Primary outcome timeframe

12 months

Results posted on

2023-06-15

Participant Flow

Participant milestones

Participant milestones
Measure	ATG-010 + Dexamethasone Open-label ATG-010 80mg plus Dexamethasone 20 mg ATG-010: 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)
Overall Study STARTED	82
Overall Study COMPLETED	82
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ATG-010 + Dexamethasone n=82 Participants Open-label ATG-010 80mg plus Dexamethasone 20 mg ATG-010: 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)
Age, Continuous	61 years STANDARD_DEVIATION 8.85 • n=99 Participants
Sex: Female, Male Female	39 Participants n=99 Participants
Sex: Female, Male Male	43 Participants n=99 Participants
Race/Ethnicity, Customized Asian	82 Participants n=99 Participants
Body Mass Index (BMI)	23 kg/m^2 STANDARD_DEVIATION 3.29 • n=99 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	ATG-010 + Dexamethasone n=82 Participants Open-label ATG-010 80mg plus Dexamethasone 20 mg ATG-010: 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)
Overall Response Rate (ORR)	24 Participants

SECONDARY outcome

Timeframe: 12 months

To evaluate progression-free survival

Outcome measures

Outcome measures
Measure	ATG-010 + Dexamethasone n=82 Participants Open-label ATG-010 80mg plus Dexamethasone 20 mg ATG-010: 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)
Progression-Free Survival (PFS)	3.7 month Interval 2.02 to 4.66

Adverse Events

ATG-010 + Dexamethasone

Serious events: 45 serious events

Other events: 82 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	ATG-010 + Dexamethasone n=82 participants at risk Open-label ATG-010 80mg plus Dexamethasone 20 mg ATG-010: 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)
Infections and infestations Peumonia	14.6% 12/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Investigations Platelet count dicreased	14.6% 12/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Infections and infestations Upper respiratory infection	4.9% 4/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Blood and lymphatic system disorders Anemia	4.9% 4/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Investigations White blood cell count decreased	2.4% 2/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Investigations Neutrophil count decreased	2.4% 2/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Metabolism and nutrition disorders Hyponatremia	2.4% 2/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Metabolism and nutrition disorders Hypokalemia	2.4% 2/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Gastrointestinal disorders Vomiting	2.4% 2/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.7% 3/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.

Other adverse events

Other adverse events
Measure	ATG-010 + Dexamethasone n=82 participants at risk Open-label ATG-010 80mg plus Dexamethasone 20 mg ATG-010: 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)
Investigations Decreased platelet count	87.8% 72/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Investigations Decreased white-cell count	82.9% 68/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Investigations Lymphocyte count decreased	76.8% 63/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Investigations Neutrophil count decreased	72.0% 59/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Investigations Weight loss	65.9% 54/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Investigations Aspartate aminotransferase increased	24.4% 20/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Investigations Alanine aminotransferase increased	23.2% 19/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Investigations Blood lactate dehydrogenase increased	19.5% 16/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Investigations γ-glutamyltransferase increased	18.3% 15/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Investigations Serum creatinine increased	13.4% 11/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Investigations C-reactive protein increased	12.2% 10/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Investigations Total protein decreased	11.0% 9/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Investigations Blood Urea increased	9.8% 8/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Investigations Blood bilirubin increased	9.8% 8/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Investigations Amylase Increased	7.3% 6/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Investigations Lipase increased	7.3% 6/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Investigations β2-microglobulin increased	7.3% 6/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Investigations α-hydroxybutyrate dehydrogenase increased	6.1% 5/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Investigations Glucose increased	6.1% 5/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Metabolism and nutrition disorders Hyponatremia	68.3% 56/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Metabolism and nutrition disorders Decreased appetite	62.2% 51/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Metabolism and nutrition disorders Hyperglycemia	57.3% 47/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Metabolism and nutrition disorders Hypocalcemia	43.9% 36/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Metabolism and nutrition disorders Hypokalaemia	37.8% 31/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Metabolism and nutrition disorders Hypoalbuminaemia	31.7% 26/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Metabolism and nutrition disorders Hypophosphatemia	23.2% 19/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Metabolism and nutrition disorders Hyperuricemia	19.5% 16/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Metabolism and nutrition disorders Hypertriglyceridemia	15.9% 13/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Metabolism and nutrition disorders Hypochloridemia	11.0% 9/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Metabolism and nutrition disorders Hypomagnesemia	7.3% 6/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Metabolism and nutrition disorders Hyperkalemia	6.1% 5/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Metabolism and nutrition disorders Hypoproteinemia	6.1% 5/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Metabolism and nutrition disorders Hypermagnesemia	6.1% 5/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Gastrointestinal disorders Nausea	78.0% 64/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Gastrointestinal disorders Vomiting	51.2% 42/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Gastrointestinal disorders Diarrhea	30.5% 25/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Gastrointestinal disorders Constipation	17.1% 14/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Gastrointestinal disorders Month ulcer	8.5% 7/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Blood and lymphatic system disorders Anemia	86.6% 71/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
General disorders Adynamia	59.8% 49/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
General disorders Fatigue	15.9% 13/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
General disorders Oedema peripheral	11.0% 9/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
General disorders Fever	9.8% 8/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Infections and infestations Lung infection	30.5% 25/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Infections and infestations Infection upper respiratory	22.0% 18/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Infections and infestations Urinary tract infection	6.1% 5/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Nervous system disorders Dizzy	18.3% 15/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Nervous system disorders Hypaesthesia	8.5% 7/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Respiratory, thoracic and mediastinal disorders Cough	12.2% 10/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.3% 6/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Psychiatric disorders Sleeplessness	22.0% 18/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Cardiac disorders Tachycardia sinus	11.0% 9/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Musculoskeletal and connective tissue disorders Back pain	8.5% 7/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Eye disorders Vision blurred	12.2% 10/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Eye disorders Cataracts	6.1% 5/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Vascular disorders Hypertension	7.3% 6/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Skin and subcutaneous tissue disorders Pruritis	7.3% 6/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.
Skin and subcutaneous tissue disorders Alopecia	6.1% 5/82 • From study drug dosed to 30 days after last study drug dose. SAE was collected from consent. The period is at least no less than 12 months.

Additional Information

Shimin Sun

Antengene Corporation

Phone: +8613701803117

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place