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This study evaluates the maintenance strategy based on risk stratification and MRD status after stem cell transplantation.
This is a single-arm, multicenter, prospective study. Participants who are R2-ISS 1,2 and MRD negative receive the single drug lenalidomide maintenance. In other circumstances, for example, patients who are R2-ISS 3 or 4 will receive daratumumab combined with lenalidomide regardless of MRD status, while patients with MRD positivity will also receive daratumumab plus lenalidomide maintenance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lenalidomide | Other | For patients with low-risk or intermediate-low risk and minimal residual disease negativity before maintenance |
|
| Daratumumab and Lenalidomide | Other | For patients with high-risk or intermediate-high risk OR minimal residual disease posivitity before maintenance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daratumumab | Drug | Patients who are R2-ISS 3 or 4 OR MRD (Minimal Residual Disease) positivity will receive daratumumab plus lenalidomide maintenance. |
|
| Measure | Description | Time Frame |
|---|---|---|
| MRD (Minimal Residual Disease) status at 12 months after maintenance | Bone marrow minimal residual disease status at 12 months after maintenance | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| CR+VGPR | complete response plus very good partial response at 12 months from maintenance | 12 months |
| Estimated 3 year-PFS | Estimated 3 year progression free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Dr, M.D. | Contact | +86-10-88326542 | pkuphliuyang@bjmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuxing Hospital | Recruiting | Beijing | Beijing Municipality | 100038 | China |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D018365 | Neoplasm, Residual |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C556306 | daratumumab |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| Lenalidomide | Drug | Patients are R2-ISS 1,2 and MRD (Minimal Residual Disease) negative after autologous stem cell transplantation. Patients will receive the single drug lenalidomide maintenance. |
|
| 3 years |
| Estimated 3 year OS | Estimated 3 year overall survival | 3 years |
| TRAEs | Treatment related adverse events | 3 years |
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
|
| The First Affiliated Hospital of Harbin Medical University | Recruiting | Harbin | Heilongjiang | 150001 | 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 |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |