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The investigators will conduct randomized and controlled clinical studies in order to preliminarily explore the efficacy and safety of low-dose cyclophosphamide and lenalidomide in maintenance therapy for MM that is not suitable for transplantation in the standard-risk group.
The investigators will conduct randomized and controlled clinical studies to preliminarily explore the efficacy and safety of low-dose cyclophosphamide in maintenance therapy for MM that is not suitable for transplantation in the standard -risk group. Standard risk group MM patients who achieve VGPR or above after initial induction and consolidation therapy will use cyclophosphamide or lenalidomide as maintain therapy for 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| arm CTX | Experimental | Cyclophosphamide monotherapy: CTX, 0.1g×7days,1/every other week, 28 days per course of treatment,total two years |
|
| arm Len | Placebo Comparator | Lenalidomide monotherapy:Len,10mg/day×21days, 28 days per course of treatment,total two years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide | Drug | Standard risk group MM patients who achieve VGPR or above after initial induction and consolidation therapy and are not suitable transplantation, are maintained with Cyclophosphamide monotherapy for 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| PFS1 | Progression-free Survival 1 | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Efficacy as assessed by IMWG | Efficacy assessed by IMWG | 3 years |
| Incidence of Safety as assessed by CTCAE 4.0 | Safety assessed by CTCAE 4.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhao Qian | Contact | 18251835035 | 540598707@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Li Feng, Doctor | Department of Hematology of Jinling Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinling Hospital | Recruiting | Nanjing | Jiangsu | China |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D000077269 | Lenalidomide |
| C015575 | vicilin protein, plant |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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|
| Lenalidomide | Drug | Standard risk group MM patients who achieve VGPR or above after initial induction and consolidation therapy and are not suitable transplantation, are maintained with Lenalidomide monotherapy for 2 years. |
|
|
| 3 years |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |