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| Name | Class |
|---|---|
| Qingdao Municipal Hospital | OTHER |
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This is a single-arm, open-label, multicenter, exploratory study initiated by investigator to evaluate the efficacy and safety of Selinexor (S) combined with pomalidomide (P) and dexamethasone (D) in the treatment of multiple myeloma with CNS involvement.
This is a single-arm, open-label, multicenter, exploratory study. The study plans to enroll patients diagnosed with multiple myeloma with CNS involvement to receive Selinexor (60 mg QW), pomalidomide (4 mg/day, on Days 1-21), and dexamethasone (40 mg/day, on Days 1, 8, 15, 22), with all agents dosed 28 days per cycle.
If patients reach maximum efficacy and have received SPD treatment for 8-12 cycles, maintenance treatment of Selinexor (20-60mg QW, optimal dose determined by the investigator) will be started and continued until disease progression or intolerable adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selinexor, pomalidomide and dexamethasone | Experimental | Patients diagnosed with multiple myeloma with CNS involvement to receive SPD treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPD:Selinexor Oral Tablet, Pomalidomide, Dexamethasone | Drug | Patients diagnosed with multiple myeloma with CNS involvement to receive Selinexor (60 mg QW), pomalidomide (4 mg/day, on Days 1-21), and dexamethasone (40 mg/day, on Days 1, 8, 15, 22), with all agents dosed 28 days per cycle. If patients reach maximum efficacy and have received SPD treatment for 8-12 cycles, maintenance treatment of Selinexor (20-60mg QW, optimal dose determined by the investigator) will be started and continued until disease progression or intolerable adverse events. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Assessed using the updated International Myeloma Working Group Response Criteria | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Assessed using the updated International Myeloma Working Group Response Criteria | From date of enrollment until date of death from any cause, assessed up to 24 months. |
| Overall response rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuelin Dou, M.D. | Contact | +86-010-82816999 | 7003 | dxldw@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jin Lu, M.D. | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C467566 | pomalidomide |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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Patients diagnosed with multiple myeloma with CNS involvement to receive Selinexor (60 mg QW), pomalidomide (4 mg/day, on Days 1-21), and dexamethasone (40 mg/day, on Days 1, 8, 15, 22), with all agents dosed 28 days per cycle.
If patients reach maximum efficacy and have received SPD treatment for 8-12 cycles, maintenance treatment of Selinexor (20-60mg QW, optimal dose determined by the investigator) will be started and continued until disease progression or intolerable adverse events.
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|
Assessed using the updated International Myeloma Working Group Response Criteria
| From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months. |
| Adverse Events | Assessed using the CTCAE criteria. | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months. |
| Qingdao Municipal Hospital | Recruiting | Qingdao | Shandong | China |
|
| 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 |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |