Trial Outcomes & Findings for A Study of Evaluating the Safety and Efficacy of ATG-010, Bortezomib, and Dexamethasone (SVd) Versus Bortezomib and Dexamethasone (Vd) in Patients With Relapsed or Refractory Multiple Myeloma (RRMM) (NCT NCT04939142)
NCT ID: NCT04939142
Last Updated: 2026-08-10
Results Overview
To evaluate progression-free survival
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
154 participants
Primary outcome timeframe
From date of randomization until the date of first documented PD (per IMWG criteria) or date of death, whichever occurs first. Participants without PD or death at the time of analysis are censored at the date of their last adequate disease assessment.
Results posted on
2026-08-10
Participant Flow
Participant milestones
| Measure |
SVd (Selinexor+Bortezomib+Dexamethasone)
Enrolled patients will be treated with ATG-010( 100 mg/QW, oral ) with Bortezomib( 1.3 mg/QW, hypodermic injection ) +dexamethasone ( 20 mg/QW, oral ) about 13.5cycles.
SVd (Selinexor+Bortezomib+dexamethasone): Randomized into two treatment Arms in a 2:1 allocation (SVd Arm or Vd Arm): (1) SVd Arm (\~100): ATG-010 + (Once a week, QW) + bortezomib (QW) + dexamethasone (BIW)
|
Vd (Bortezomib+Dexamethasone)
Enrolled patients will be treated with Bortezomib( 1.3 mg/QW, hypodermic injection ) +dexamethasone ( 20 mg/QW, oral ) about 13.5 cycles.
Vd (Bortezomib+dexamethasone): Vd Arm (\~50): Bortezomib (Cycles 1-8 \[BIW\], Cycles ≥ 9 \[QW\]) + dexamethasone (Cycles 1-8 \[Four times a week\], Cycles ≥ 9 \[BIW\])
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
53
|
|
Overall Study
COMPLETED
|
100
|
52
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Evaluating the Safety and Efficacy of ATG-010, Bortezomib, and Dexamethasone (SVd) Versus Bortezomib and Dexamethasone (Vd) in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)
Baseline characteristics by cohort
| Measure |
SVd (Selinexor+Bortezomib+Dexamethasone)
n=101 Participants
Enrolled patients will be treated with ATG-010( 100 mg/QW, oral ) with Bortezomib( 1.3 mg/QW, hypodermic injection ) +dexamethasone ( 20 mg/QW, oral ) about 13.5cycles.
SVd (Selinexor+Bortezomib+dexamethasone): Randomized into two treatment Arms in a 2:1 allocation (SVd Arm or Vd Arm): (1) SVd Arm (\~100): ATG-010 + (Once a week, QW) + bortezomib (QW) + dexamethasone (BIW)
|
Vd (Bortezomib+Dexamethasone)
n=53 Participants
Enrolled patients will be treated with Bortezomib( 1.3 mg/QW, hypodermic injection ) +dexamethasone ( 20 mg/QW, oral ) about 13.5 cycles.
Vd (Bortezomib+dexamethasone): Vd Arm (\~50): Bortezomib (Cycles 1-8 \[BIW\], Cycles ≥ 9 \[QW\]) + dexamethasone (Cycles 1-8 \[Four times a week\], Cycles ≥ 9 \[BIW\])
|
Total
n=154 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.1 years
STANDARD_DEVIATION 8.45 • n=54 Participants
|
63 years
STANDARD_DEVIATION 7.23 • n=54 Participants
|
61.8 years
STANDARD_DEVIATION 8.07 • n=27 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=54 Participants
|
25 Participants
n=54 Participants
|
67 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=54 Participants
|
28 Participants
n=54 Participants
|
87 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
101 Participants
n=54 Participants
|
53 Participants
n=54 Participants
|
154 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
|
Body Mass Index (BMI)
|
24.3 kg/m^2
STANDARD_DEVIATION 2.96 • n=54 Participants
|
24.07 kg/m^2
STANDARD_DEVIATION 3.461 • n=54 Participants
|
24.22 kg/m^2
STANDARD_DEVIATION 3.132 • n=27 Participants
|
PRIMARY outcome
Timeframe: From date of randomization until the date of first documented PD (per IMWG criteria) or date of death, whichever occurs first. Participants without PD or death at the time of analysis are censored at the date of their last adequate disease assessment.To evaluate progression-free survival
Outcome measures
| Measure |
SVd (Selinexor+Bortezomib+Dexamethasone)
n=100 Participants
Enrolled patients will be treated with ATG-010( 100 mg/QW, oral ) with Bortezomib( 1.3 mg/QW, hypodermic injection ) +dexamethasone ( 20 mg/QW, oral ) about 13.5cycles.
SVd (Selinexor+Bortezomib+dexamethasone): Randomized into two treatment Arms in a 2:1 allocation (SVd Arm or Vd Arm): (1) SVd Arm (\~100): ATG-010 + (Once a week, QW) + bortezomib (QW) + dexamethasone (BIW)
|
Vd (Bortezomib+Dexamethasone)
n=52 Participants
Enrolled patients will be treated with Bortezomib( 1.3 mg/QW, hypodermic injection ) +dexamethasone ( 20 mg/QW, oral ) about 13.5 cycles.
Vd (Bortezomib+dexamethasone): Vd Arm (\~50): Bortezomib (Cycles 1-8 \[BIW\], Cycles ≥ 9 \[QW\]) + dexamethasone (Cycles 1-8 \[Four times a week\], Cycles ≥ 9 \[BIW\])
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
8.11 month
Interval 6.28 to 11.99
|
6.34 month
Interval 5.55 to 11.79
|
SECONDARY outcome
Timeframe: From randomization until the earlier of IRC-confirmed PD or start of subsequent anti-myeloma therapy, assessed up to 2 years.evaluated by IRC (PR + VGPR + CR + sCR)
Outcome measures
| Measure |
SVd (Selinexor+Bortezomib+Dexamethasone)
n=101 Participants
Enrolled patients will be treated with ATG-010( 100 mg/QW, oral ) with Bortezomib( 1.3 mg/QW, hypodermic injection ) +dexamethasone ( 20 mg/QW, oral ) about 13.5cycles.
SVd (Selinexor+Bortezomib+dexamethasone): Randomized into two treatment Arms in a 2:1 allocation (SVd Arm or Vd Arm): (1) SVd Arm (\~100): ATG-010 + (Once a week, QW) + bortezomib (QW) + dexamethasone (BIW)
|
Vd (Bortezomib+Dexamethasone)
n=53 Participants
Enrolled patients will be treated with Bortezomib( 1.3 mg/QW, hypodermic injection ) +dexamethasone ( 20 mg/QW, oral ) about 13.5 cycles.
Vd (Bortezomib+dexamethasone): Vd Arm (\~50): Bortezomib (Cycles 1-8 \[BIW\], Cycles ≥ 9 \[QW\]) + dexamethasone (Cycles 1-8 \[Four times a week\], Cycles ≥ 9 \[BIW\])
|
|---|---|---|
|
Objective Response Rate (ORR)
|
73 Participants
|
33 Participants
|
Adverse Events
SVd (Selinexor+Bortezomib+Dexamethasone)
Serious events: 51 serious events
Other events: 100 other events
Deaths: 6 deaths
Vd(Bortezomib+Dexamethasone)
Serious events: 24 serious events
Other events: 51 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
SVd (Selinexor+Bortezomib+Dexamethasone)
n=100 participants at risk
Enrolled patients will be treated with ATG-010( 100 mg/QW, oral ) with Bortezomib( 1.3 mg/QW, hypodermic injection ) +dexamethasone ( 20 mg/QW, oral ) about 13.5cycles.
|
Vd(Bortezomib+Dexamethasone)
n=52 participants at risk
Enrolled patients will be treated with Bortezomib( 1.3 mg/QW, hypodermic injection ) +dexamethasone ( 20 mg/QW, oral ) about 13.5 cycles.
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal system diseases
|
4.0%
4/100 • AEs: from first dose to 30 days post-last dose; SAEs: from consent to 30 days post-last dose. Total collection period: up to 2 years.
|
7.7%
4/52 • AEs: from first dose to 30 days post-last dose; SAEs: from consent to 30 days post-last dose. Total collection period: up to 2 years.
|
|
Cardiac disorders
Heart diseases
|
5.0%
5/100 • AEs: from first dose to 30 days post-last dose; SAEs: from consent to 30 days post-last dose. Total collection period: up to 2 years.
|
3.8%
2/52 • AEs: from first dose to 30 days post-last dose; SAEs: from consent to 30 days post-last dose. Total collection period: up to 2 years.
|
|
General disorders
General disorders and administration site conditions
|
4.0%
4/100 • AEs: from first dose to 30 days post-last dose; SAEs: from consent to 30 days post-last dose. Total collection period: up to 2 years.
|
1.9%
1/52 • AEs: from first dose to 30 days post-last dose; SAEs: from consent to 30 days post-last dose. Total collection period: up to 2 years.
|
|
Infections and infestations
Infectious pneumonia
|
29.0%
29/100 • AEs: from first dose to 30 days post-last dose; SAEs: from consent to 30 days post-last dose. Total collection period: up to 2 years.
|
21.2%
11/52 • AEs: from first dose to 30 days post-last dose; SAEs: from consent to 30 days post-last dose. Total collection period: up to 2 years.
|
|
Eye disorders
Cataract
|
19.0%
19/100 • AEs: from first dose to 30 days post-last dose; SAEs: from consent to 30 days post-last dose. Total collection period: up to 2 years.
|
1.9%
1/52 • AEs: from first dose to 30 days post-last dose; SAEs: from consent to 30 days post-last dose. Total collection period: up to 2 years.
|
|
Blood and lymphatic system disorders
Decreased platelet count
|
10.0%
10/100 • AEs: from first dose to 30 days post-last dose; SAEs: from consent to 30 days post-last dose. Total collection period: up to 2 years.
|
7.7%
4/52 • AEs: from first dose to 30 days post-last dose; SAEs: from consent to 30 days post-last dose. Total collection period: up to 2 years.
|
|
Nervous system disorders
Nervous system disease
|
6.0%
6/100 • AEs: from first dose to 30 days post-last dose; SAEs: from consent to 30 days post-last dose. Total collection period: up to 2 years.
|
5.8%
3/52 • AEs: from first dose to 30 days post-last dose; SAEs: from consent to 30 days post-last dose. Total collection period: up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory system, thoracic and mediastinal diseases
|
6.0%
6/100 • AEs: from first dose to 30 days post-last dose; SAEs: from consent to 30 days post-last dose. Total collection period: up to 2 years.
|
3.8%
2/52 • AEs: from first dose to 30 days post-last dose; SAEs: from consent to 30 days post-last dose. Total collection period: up to 2 years.
|
Other adverse events
| Measure |
SVd (Selinexor+Bortezomib+Dexamethasone)
n=100 participants at risk
Enrolled patients will be treated with ATG-010( 100 mg/QW, oral ) with Bortezomib( 1.3 mg/QW, hypodermic injection ) +dexamethasone ( 20 mg/QW, oral ) about 13.5cycles.
|
Vd(Bortezomib+Dexamethasone)
n=52 participants at risk
Enrolled patients will be treated with Bortezomib( 1.3 mg/QW, hypodermic injection ) +dexamethasone ( 20 mg/QW, oral ) about 13.5 cycles.
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
98.0%
98/100 • AEs: from first dose to 30 days post-last dose; SAEs: from consent to 30 days post-last dose. Total collection period: up to 2 years.
|
90.4%
47/52 • AEs: from first dose to 30 days post-last dose; SAEs: from consent to 30 days post-last dose. Total collection period: up to 2 years.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
90.0%
90/100 • AEs: from first dose to 30 days post-last dose; SAEs: from consent to 30 days post-last dose. Total collection period: up to 2 years.
|
76.9%
40/52 • AEs: from first dose to 30 days post-last dose; SAEs: from consent to 30 days post-last dose. Total collection period: up to 2 years.
|
|
Gastrointestinal disorders
Gastrointestinal system diseases
|
82.0%
82/100 • AEs: from first dose to 30 days post-last dose; SAEs: from consent to 30 days post-last dose. Total collection period: up to 2 years.
|
73.1%
38/52 • AEs: from first dose to 30 days post-last dose; SAEs: from consent to 30 days post-last dose. Total collection period: up to 2 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place