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The purpose of the study is to compare the efficacy of QLS32105 (SC) in combination with Pomalidomide, and QLS32105 (SC) in combination with QL2109 or Daratumumab, and QLS32105 (SC) in combination with QL2109 or Daratumumab and Pomalidomide, and QLS32105(SC) in combination with Bortezomib and Lenalidomide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLS32015(SC) in combination with Pomalidomide | Experimental | Participants will receive QLS32015 as SC injections; Pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug. |
|
| QLS32015(SC) in combination with QL2109 or Daratumumab. | Experimental | Participants will receive QLS32015 and QL2109 or Daratumumab as SC injections; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug. |
|
| QLS32015(SC) in combination with QL2109 or Daratumumab and Pomalidomide | Experimental | Participants will receive QLS32015 and QL2109 or Daratumumab as SC injections; Pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug |
|
| QLS32015(SC) in combination with Bortezomib for injection and Lenalidomide | Experimental | Participants will receive QLS32015 and Bortezomib as SC injections; Lenalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLS32015 | Drug | QLS32015 will be administered subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR (Partial Response [PR] or Better) | Overall response (PR or better) is defined as percentage of participants who have a PR or better per International Myeloma Working Group (IMWG) criteria | Up to 2 years |
| Overall Minimal Residual Disease (MRD) | MRD-negative is defined as proportion of participants who achieve MRD negativity at a threshold of 10^-5 at any timepoint after the first dose of study drug and before disease progression or start of subsequent antimyeloma therapy | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS is defined as time from the date of randomization to the first documentation of disease progression, or death due to any cause, whichever is reported first | Up to 2 years |
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Inclusion Criteria:
Diagnosis of multiple myeloma confirmed according to the 2016 International Myeloma Working Group (IMWG) diagnostic criteria;
Prior therapy: Relapsed, progressed, or intolerant to ≥1 prior line of anti-multiple myeloma therapy;
Measurable disease at screening, defined by at least one of the following:
Exclusion Criteria:
History of Grade 3 or higher cytokine release syndrome (CRS) associated with any T-cell redirecting therapy (e.g., CD3-redirecting technologies or CAR-T cell therapy);
Prior anti-myeloma therapies within the specified timeframes before enrollment:
Radiotherapy within 14 days (except low-dose palliative radiation [10-30 Gy]);
Prior intolerance to Pomalidomide (applies to treatment cohorts containing Pomalidomide);
Prior intolerance to Bortezomib (applies to treatment cohorts containing bortezomid);
Prior intolerance to Lenalidomide (applies to treatment cohorts containing Lenalidomide);
Prior intolerance to Daratumumab (applies to treatment cohorts containing Daratumumab).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gang An, Professor | Contact | 008613502181109 | angang@ihcams.ac.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 |
| D003907 | Dexamethasone |
| C556306 | daratumumab |
| D000069286 | Bortezomib |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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|
| Pomalidomide | Drug | Pomalidomide will be self-administered as a single dose orally |
|
| Dexamethasone | Drug | Dexamethasone will be administered orally or intravenously |
|
| QL2109 or Daratumumab | Drug | QL2109 or Daratumumab will be administered subcutaneously. |
|
| Bortezomib | Drug | Bortezomib will be administered subcutaneously |
|
| Lenalidomide | Drug | Lenalidomide will be self-administered as a single dose orally |
|
| 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 |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |