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This is a Phase III Randomized, Controlled, Multicenter, Open-label Study of ATG-010, Bortezomib, and Dexamethasone (SVd) Versus Bortezomib and Dexamethasone (Vd) in Patients with Relapsed or Refractory Multiple Myeloma (RRMM).
This is a Phase III Randomized, Controlled, Multicenter, Open-label Study of ATG-010, Bortezomib, and Dexamethasone (SVd) Versus Bortezomib and Dexamethasone (Vd) in Patients with Relapsed or Refractory Multiple Myeloma (RRMM). About 150 subjects are planned to be enrolled in this study, and be randomized into two treatment Arms in a 2:1 allocation (SVd Arm or Vd Arm).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SVd (Selinexor+Bortezomib+dexamethasone) | Experimental | 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) | Experimental | Enrolled patients will be treated with Bortezomib( 1.3 mg/QW, hypodermic injection ) +dexamethasone ( 20 mg/QW, oral ) about 13.5 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SVd (Selinexor+Bortezomib+dexamethasone) | Combination Product | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | To evaluate progression-free survival | Three years after last patient first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | The estimates of Kaplan-Meier | Three years after last patient first dose |
| Duration of Response (DOR) | To evaluate duration of response |
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Inclusion Criteria:
Understand and voluntarily sign an informed consent form (ICF).
Age ≥ 18 years.
Confirmed MM with measurable disease per IMWG guidelines, and meet at least 1 of the following:
Had at least 1 prior anti-MM regimen and no more than 3 prior anti-MM regimens. Induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as 1 anti-MM regimen.
Valid evidence of progressive MM (based on the Investigator's determination according to the IMWG response criteria) on or after their last regimen.
Must have an ECOG Status score of 0, 1, or 2.
Renal function should meet the following criteria: creatinine clearance [CrCl] rates ≥ 20 mL/min (Calculated using the formula of Cockroft and Gault).
Resolution of any clinically significant non-hematological toxicities (If any) from previous treatments to Grade ≤1 or baseline by C1D1. Subject with chronic, stable Grade 2 non hematological toxicities may be included following approval from the Medical Monitor.
Female subjects of childbearing potential must have a negative serum pregnancy test at Screening. Female subjects of childbearing potential and fertile male subjects must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin Lu, PhD | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | 230022 | China | ||
| The First Affiliated Hospital OF USTC |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 31, 2026 | |
| Reset | Apr 17, 2026 | |
| Release | May 28, 2026 |
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| Vd (Bortezomib+dexamethasone) | Combination Product | Vd Arm (~50): Bortezomib (Cycles 1-8 [BIW], Cycles ≥ 9 [QW]) + dexamethasone (Cycles 1-8 [Four times a week], Cycles ≥ 9 [BIW]) |
|
| Three years after last patient first dose |
| Objective response rate (ORR) | evaluated by IRC (PR + VGPR + CR + sCR) | Three years after last patient first dose |
| Progression-free survival(PFS2) | PFS after further treatment followed by treatment with SVd/Vd | Three years after last patient first dose |
| Time to remission(TTR) | To compare the efficacy of treatment with SVd and Vd | Three years after last patient first dose |
| VGPR+CR+sCR | Proportion of subjects of VGPR + CR + sCR | Three years after last patient first dose |
| Safety Endpoints | Incidence of any Grade ≥ 2 peripheral neuropathy events | Three years after last patient first dose |
| Hefei |
| Anhui |
| 230031 |
| China |
| The First Affiliated Hospital of Wannan Medical College | Wuhu | Anhui | 241001 | China |
| Beijing Chao-Yang Hospital | Beijing | Beijing Municipality | 100043 | China |
| Peking University People'S Hospital | Beijing | Beijing Municipality | 100044 | China |
| Xinqiao Hospital Army Medical University | Chongqing | Chongqing Municipality | 400037 | China |
| Guangdong Provincial People'S Hospital | Guangzhou | Guangdong | 510000 | China |
| Sun Yat-Sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| Nanfang Hospital | Guangzhou | Guangdong | 510515 | China |
| Shenzhen Second People'S Hospital | Shenzhen | Guangdong | 518035 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450008 | China |
| Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology | Wuhan | Hubei | 430030 | China |
| Xiangya Hospital Central South University | Changsha | Hunan | 410008 | China |
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | 410013 | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China |
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | 221000 | China |
| Affiliated Hospital of Nantong University | Nanchang | Jiangxi | 330006 | China |
| The First Hospital of Nanchang | Nanchang | Jiangxi | 330006 | China |
| Shengjing Hospital China Medical University | Shenyang | Liaoning | 110004 | China |
| Shandong Provincial Hospital | Jinan | Shandong | 250021 | China |
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | 266000 | China |
| Qingdao Municipal Hospital | Qingdao | Shandong | v | China |
| Qilu Hospital of Shangdong University | Jinan | Shangdong | 250012 | China |
| Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 09022836 | China |
| Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
| Zhongshan Hospital Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University | Shanghai | Shanghai Municipality | 200233 | China |
| Sichuan Provincial People's Hospital | Chengdu | Sichuan | 610072 | China |
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300052 | China |
| Tianjin Medical University Cancer Institute & Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| Sir Run Run Shaw Hospital Zhejiang University of Medicine | Hangzhou | Zhejiang | 310016 | China |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hanzhou | Zhejiang | 310003 | China |
| Ningbo First Hospital | Ningbo | Zhejiang | 315010 | China |
| Reset | Jun 23, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 31, 2026 | Apr 17, 2026 | |||
| May 28, 2026 | Jun 23, 2026 |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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