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We propose to conduct an ancillary prospective evaluation of the impact of Dara-Len-Dex discontinuation after 2 years, on the persistence of MRD negativity in patients that were MRD negative at 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult patients who are included in the CONFIRM phase III trial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assessment of MRD | Other | Bone marrow aspirate for assessment of MRD will be performed at 2 years (+/- 3 month) after randomization in patients still under treatment and in complete response. Thereafter, bone marrow aspirate for assessment of MRD will be repeated at 3 and 4 years in patients that maintain complete response, irrespective of the randomization arm and therefore of treatment administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients that maintain MRD negativity | Rate of patients that maintain MRD negativity at 3 and 4 years after inclusion in the current protocol in the continuous Dara-Len-Dex therapy group versus fixed duration Dara-Len-Dex therapy (2 years) group. | 3 and 4 years after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| PFS at 2 years | PFS at 2 years after initial assessment of MRD negativity, which is defined as the duration from the date of MRD measurement to either progressive disease, according to the IMWG criteria, or death. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients who are included in the CONFIRM phase III trial
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamad MOHTY, PUPH | Contact | + 33 149 28 26 20 | mohamad.mohty@inserm.fr | |
| Florent MALARD, MD | Contact | +33 149 28 09 68 | malardf@yahoo.fr |
| Name | Affiliation | Role |
|---|---|---|
| Mohamad MOHTY, PUPH | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hematology, Hospital Saint Antoine | Recruiting | Paris | 75012 | France |
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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 |
| 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 |
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