Can adding selinexor to standard therapy extend remission in Hard-to-Treat myeloma?
NCT ID NCT04939142
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This phase III trial is testing whether adding selinexor to a standard two-drug regimen (bortezomib and dexamethasone) can help people with relapsed or refractory multiple myeloma—a blood cancer that has returned or stopped responding to treatment. About 154 adults with measurable disease will be randomly assigned to receive either the three-drug combination or the standard two-drug regimen. The main goal is to see if the triple therapy improves progression-free survival, meaning how long patients live without their cancer worsening.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Selinexor combined with bortezomib and dexamethasone
- What this could lead to
- If successful, this combination could offer a new treatment option that helps people with relapsed or refractory multiple myeloma live longer without their cancer progressing.
- What could go wrong
- This is an early-stage phase III trial, so results are not guaranteed. The addition of selinexor may increase side effects, and the benefit over standard care is still uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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154 people
The number who actually took part.
- Started
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Jul 2021
- Finished
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Oct 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Understand and voluntarily sign an informed consent form (ICF). 2. Age ≥ 18 years. 3. Confirmed MM with measurable disease per IMWG guidelines, and meet at least 1 of the following: 1. Serum M-protein ≥ 0.5 g/dL (\> 5 g/L) by serum protein electrophoresis (SPEP) or for immunoglobulin IgA, IgD myeloma, replaced by quantitative serum IgA, IgD levels; or 2. Urinary M-protein level ≥ 200 mg/24 hours; or 3. Serum FLC ≥ 100 mg/L, provided that the serum FLC ratio is abnormal (Normal FLC ratio: 0.26 to 1.65). 4. 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. 5. Valid evidence of progressive MM (based on the Investigator's determination according to the IMWG response criteria) on or after their last regimen. 6. Must have an ECOG Status score of 0, 1, or 2. 7. Renal function should meet the following criteria: creatinine clearance \[CrCl\] rates ≥ 20 mL/min (Calculated using the formula of Cockroft and Gault). 8. 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. 9. 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: 1. Prior exposure to SINE compounds (Including ATG-010), or suspected allergy to SINE or similar drugs. 2. Active plasma cell leukemia. 3. Documented systemic light chain amyloidosis. 4. MM involving the central nervous system. 5. POEMS syndrome (Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes). 6. Spinal cord compression related to MM. 7. Greater than Grade 2 peripheral neuropathy or Grade ≥ 2 peripheral neuropathy with pain at baseline, regardless of whether the subject is currently receiving medication. 8. Known intolerance, hypersensitivity, or contraindication to glucocorticoids. 9. Active graft versus host disease (After allogeneic stem cell transplantation) at screening. 10. Uncontrolled active infections requiring intravenous antibiotics, antivirals, or antifungal therapy in 2 weeks prior to C1D1. 11. Major surgery within 4 weeks prior to C1D1. 12. Known active human immunodeficiency virus (HIV) infection or HIV seropositivity. 13. Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C virus ribonucleic acid (RNA) or hepatitis B virus deoxyribonucleic acid (HBV-DNA). 14. Pregnant or lactating women. 15. Life expectancy of \< 4 months. 16. Any active gastrointestinal dysfunction interfering with the subject's ability to swallow tablets, or any active gastrointestinal dysfunction that could interfere with absorption of study treatment. 17. Any active, serious psychiatric, medical, or other conditions/situations that, in the opinion of the Investigator, could interfere with treatment, compliance, or the ability to give informed consent. 18. Contraindication to any of the required concomitant drugs or supportive treatments. 19. Any diseases or complications which may interfere with the study procedures. 20. Subject unwilling or unable to comply with the protocol.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Affiliated Hospital of Nantong University
Nanchang, Jiangxi, 330006, China
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Beijing Chao-Yang Hospital
Beijing, Beijing Municipality, 100043, China
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Guangdong Provincial People'S Hospital
Guangzhou, Guangdong, 510000, China
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Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
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Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
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Nanfang Hospital
Guangzhou, Guangdong, 510515, China
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Ningbo First Hospital
Ningbo, Zhejiang, 315010, China
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Peking University People'S Hospital
Beijing, Beijing Municipality, 100044, China
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Qilu Hospital of Shangdong University
Jinan, Shangdong, 250012, China
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Qingdao Municipal Hospital
Qingdao, Shandong, v, China
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Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 09022836, China
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Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
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Shandong Provincial Hospital
Jinan, Shandong, 250021, China
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Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University
Shanghai, Shanghai Municipality, 200233, China
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Shengjing Hospital China Medical University
Shenyang, Liaoning, 110004, China
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Shenzhen Second People'S Hospital
Shenzhen, Guangdong, 518035, China
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Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
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Sir Run Run Shaw Hospital Zhejiang University of Medicine
Hangzhou, Zhejiang, 310016, China
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Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060, China
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The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000, China
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The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000, China
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The First Affiliated Hospital OF USTC
Hefei, Anhui, 230031, China
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The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
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The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, 241001, China
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The First Affiliated Hospital, Zhejiang University School of Medicine
Hanzhou, Zhejiang, 310003, China
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The First Hospital of Nanchang
Nanchang, Jiangxi, 330006, China
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The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
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Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060, China
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Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
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Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, 430030, China
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Xiangya Hospital Central South University
Changsha, Hunan, 410008, China
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Xinqiao Hospital Army Medical University
Chongqing, Chongqing Municipality, 400037, China
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Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new drug combo outsmart Hard-to-Treat myeloma?
- Engineered immune cells take on Hard-to-Treat myeloma
- Home infusion for myeloma drug passes early safety check
- New hope for multiple myeloma: phase 3 trial launches
- New CAR T-Cell therapy targets Hard-to-Treat myeloma
- New 'Off-the-Shelf' CAR-T therapy takes on Hard-to-Treat myeloma