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This is a single - arm, multi - cohort, open - label, multi - center Phase II clinical study. It aims to evaluate the efficacy and safety of F182112 combined with different administration regimens in patients with relapsed or refractory multiple myeloma.
The study plans to enroll approximately 90 patients with relapsed or refractory multiple myeloma at around 20 study centers.
Primary objective:
The objective response rate (ORR) of F182112 combined with different administration regimens in patients with relapsed or refractory multiple myeloma.
Secondary objective:
The efficacy of F182112 combined with different administration regimens in patients with relapsed or refractory multiple myeloma (complete response rate [CRR], progression - free survival [PFS], overall survival [OS], duration of response [DOR], time to response [TTR], time to progression [TTP], minimal residual disease - negative rate); The incidence and grade of adverse events (AE), serious adverse events (SAE), abnormal laboratory test indicators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| F182112 combined with different administration regimens | Experimental | F182112 combined with different administration regimens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F182112+P | Drug | F182112 + P |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression - Free Survival(PFS) | Up to 2 years | |
| Minimal Residual Disease - negative rate | Up to 2 years | |
| Number of Participants With Adverse Events and Serious Adverse Events |
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Inclusion Criteria:
Be diagnosed with multiple myeloma according to the IMWG 2016 criteria.
The previous treatment regimen must contain lenalidomide (lenalidomide must be used continuously for at least 2 cycles) and a proteasome inhibitor.
Participants whose previous treatment regimen contained pomalidomide or who were intolerant to pomalidomide cannot be enrolled.
Have an ECOG performance status score of 0 - 2.
Meet at least one of the following measurable disease indicators:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lu gui Qiu Doctor | Contact | (+86)13821266636 | Qiulg@ihcams.ac.cn | |
| Shaohong Yin | Contact | 15764210553 | yinshaohong@vip.lunan.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital | Recruiting | Tianjin | China |
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| 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 |
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| ID | Term |
|---|---|
| C467566 | pomalidomide |
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| F182112+CD38 | Drug | F182112+CD38 |
|
|
| Up to 2 years |
| Overall Survival(OS) | Up to 2 years |
| Duration of Response(DOR) | up to 2 years |
| 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 |