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The purpose of this study is to evaluate the efficacy and safety of SCTC21C plus cyclophosphamide, bortezomib and dexamethasone (VCd) compared with VCd alone in treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.
This study comprises two phases: Part 1 is the safety run in, while Part 2 is a randomized, controlled, open-label, multicenter study. Both parts are divided into three stages: the screening period (up to 28 days before first dose/randomization), the treatment period (from Cycle 1 [28 days] Day 1 and continues until disease progression or unacceptable toxicity), and the follow-up period (Postintervention). Safety endpoints include treatment-emergent adverse events , treatment-related adverse events, serious adverse events, clinical laboratory tests, vital signs, physical examinations, electrocardiograms , etc. Efficacy endpoints include Overall Complete Hematologic Response (CHR)，objective response rate (ORR), Hematologic Very Good Partial Response (VGPR) or Better Rate, Overall Survival (OS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCTC21C + VCd (S-VCd) | Experimental |
| |
| VCd | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCTC21C | Drug | Pharmaceutical form: Solution for infusion； Route of administration: Subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Overall Complete Hematologic Response (CHR) | Overall CHR rate was defined as percentage of participants who achieved CHR, according to the International Amyloidosis Consensus Criteria. | Up to approximately 50 months after the First Participant In (FPI) |
| Measure | Description | Time Frame |
|---|---|---|
| Major Organ Deterioration Progression-Free Survival (MOD-PFS) | MOD-PFS was defined as duration from the date of randomization to either hematologic progression, or major organ deterioration (clinical manifestation of cardiac failure or renal failure), or death, whichever occurred first. | Up to approximately 50 months after the FPI |
| Measure | Description | Time Frame |
|---|---|---|
| PRO: EQ-5D-5L | Health state utility and health status will be assessed using the European Quality of Life Group questionnaire with 5 dimensions and 5 levels per dimension (EQ-5D-5L) | Up to approximately 50 months after the FPI |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
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| Bortezomib | Drug | Pharmaceutical form: Lyophilized powder for injection； Route of administration: Subcutaneous |
|
| Dexamethasone | Drug | Pharmaceutical form: Tablets, ampoules or vials for injection； Route of administration: Oral/Intravenous |
|
| Cyclophosphamide | Drug | Pharmaceutical form: Tablets, ampoules or vials for injection； Route of administration: Oral/Intravenous |
|
| Percentage of Participants Who Achieved Complete Hematologic Response (CHR) at 6 Months |
CHR rate was defined as percentage of participants who achieved CHR, according to the International Amyloidosis Consensus Criteria. |
| Month 6 |
| Duration of Complete Hematologic Response (CHR) | Duration of CHR was defined as the time between the date of initial documentation of CHR to the date of first documented evidence of hematologic progressive diseased. | Up to approximately 50 months after the FPI |
| Hematologic Very Good Partial Response (VGPR) or Better Rate | Hematologic VGPR or Better Rate was defined as percentage of participants who achieved hematologic Complete response (CR) or VGPR. | Up to approximately 50 months after the FPI |
| Overall Survival (OS) | Overall survival (OS) was measured from the date of randomization to the date of the participant's death. | Up to approximately 50 months after the FPI |
| Adverse Events | Treatment-emergent adverse events/serious adverse events | Up to approximately 50 months after the FPI |
| ID | Term |
|---|---|
| D000686 | Amyloidosis |
| ID | Term |
|---|---|
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| D003907 | Dexamethasone |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| 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 |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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