Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Janssen, LP | INDUSTRY |
| Baystate Health | OTHER |
| Boston Medical Center | OTHER |
| Dana-Farber Cancer Institute |
Not provided
Not provided
Not provided
Objective 1: To test whether treatment with plasma exchange improves renal recovery in patients with light chain cast nephropathy Objective 2: To compare renal outcomes among patients treated with plasma exchange versus daratumumab-based regimens versus non-daratumumab based-regimens.
Objective 1:
We will collect data from patients treated with plasma exchange from major centers across the United States to investigate whether plasma exchange improves renal outcomes.
Specifically, we will collect data on at least 150 patients treated with plasma exchange along with 300 control patients not treated with plasma exchange.
Objective 2:
We will compare renal outcomes among patients with light chain cast nephropathy and AKI treated with plasma exchange (n=150) versus daratumumab based regimen (eg Dara-CyborD) (n=150) versus other novel regimens (e.g., CyborD or another non-daratumumab-based regimen) (n=150). We will examine whether patients who receive dara-based regimens are more likely to have renal recovery compared to patients who do not receive dara-based regimens and to patients who receive plasma exchange. Given the infrequency with which plasma exchange is performed on a single-center level, we will compare outcomes among patients treated with plasma exchange, utilizing data from the multicenter study to those patients who were treated with daratumumab-based regimens without plasma exchange versus non- daratumumab-based regimen.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated with plasma exchange | Treated with plasma exchange ithin 30 days of diagnosis of light chain cast nephropathy |
| |
| Patients not treated with plasma exchange | Patients not treated with plasma exchange within 30 days of diagnosis of light chain cast nephropathy | ||
| Patients treated with daratumumab | Patients treated with daratumumab within 30 days of diagnosis of light chain cast nephropathy |
| |
| Patients not treated with daratumumab | Patients treated with daratumumab within 30 days of diagnosis of light chain cast nephropathy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasma exchange | Procedure | Patients treated with plasma exchange within 30 days of diagnosis of light chain cast nephropathy Patients not treated with daratumumab within 30 days of diagnosis of light chain cast nephropathy |
| Measure | Description | Time Frame |
|---|---|---|
| The primary composite outcome is the rate of survival with renal recovery within 90 days from the diagnosis of light chain cast nephropathy. | To meet the primary outcome, patients must be alive, not RRT-dependent (e.g., were never on dialysis/no longer on dialysis), and have a decline of at least one stage of AKI severity compared to their highest AKI stage achieved at the time of light chain cast nephropathy-associated AKI. AKI staging will be based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria, where stage 1 is a 1.5-1.9-fold rise in SCr from baseline; stage 2 is a 2-2.9-fold rise from baseline; and stage 3 is a 3-fold rise in SCr from baseline or initiation of RRT. Baseline SCr is defined as the lowest SCr in the 365 days preceding the diagnosis of light chain cast nephropathy. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with Receipt of RRT within 30 days, 60 days, and 90 days following diagnosis of light chain cast nephropathy | The proportion of patients with Receipt of RRT within 30 days, 60 days, and 90 days following diagnsosis of LCCN | 30, 60, 90 days |
| The proportion of patients with Progressive AKI |
Not provided
Inclusion Criteria for Plasma Exchange-Treated Patients:
Inclusion Criteria for Control Patients:
Exclusion Criteria for Both Plasma Exchange-Treated Patients and Control Patients:
Not provided
Not provided
Not provided
Patients with multiple myeloma and clinically-suspected or biopsy-proven light chain cast nephropathy
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shruti Gupta, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02130 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D010951 | Plasma Exchange |
| C556306 | daratumumab |
| ID | Term |
|---|---|
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D010956 | Plasmapheresis |
Not provided
Not provided
| OTHER |
| Massachusetts General Hospital | OTHER |
| Mayo Clinic | OTHER |
| M.D. Anderson Cancer Center | OTHER |
| Medical University of South Carolina | OTHER |
| H. Lee Moffitt Cancer Center and Research Institute | OTHER |
| Icahn School of Medicine at Mount Sinai | OTHER |
| Northwell Health | OTHER |
| Ochsner Health System | OTHER |
| Ohio State University | OTHER |
| Stanford University | OTHER |
| Texas Medical Center | UNKNOWN |
| Thomas Jefferson University | OTHER |
| University of Alabama at Birmingham | OTHER |
| University of California, Los Angeles | OTHER |
| University of Chicago | OTHER |
| University of Colorado Health | OTHER |
| University of Minnesota | OTHER |
| University of New Mexico | OTHER |
| University of Pennsylvania | OTHER |
| University of Pittsburgh | OTHER |
| University of Virginia | OTHER |
| University of Washington | OTHER |
Not provided
Not provided
Not provided
| Daratumumab | Drug | Patients treated with daratumumab within 30 days of diagnosis of light chain cast nephropathy |
|
Defined as progression from existing AKI (stage 2) to a higher stage (stage 3 or receipt of RRT) within 30, 60, and 90 days following diagnosis of light chain cast nephropathy. AKI staging at each of these time points will be defined based on KDIGO criteria outlined above. |
| 30, 60, 90 days |
| Survival to hospital discharge | Survival to hospital discharge and KRT-independent among patients admitted within 30 days of the diagnosis of light chain cast nephropathy. | 30 days |
| Renal function (SCr) at hospital discharge | Renal function (SCr) at hospital discharge (% increase compared to baseline) among patients who are admitted within 30 days of their diagnosis of light chain cast nephropathy | 30 days |
| Time to first renal recovery | Renal recovery will be defined as not RRT-dependent, and with nadir SCr returning to <50% of baseline. This will be assessed within 180 days following the diagnosis of light chain cast nephropathy | 180 days |
| Kidney recovery | at 30 (+/-15), 60 (+/-15), 90 (+/-30) days, and 180 days (+/-60 days) following the diagnosis of light chain cast nephropathy, , defined as survival, KRT-independent, and with SCr <1.5-fold baseline at each of the above time points. | 30 (+/-15), 60 (+/-15), 90 (+/-30) days, and 180 days (+/-60 days) |
| Overall survival at day 90, 180, 360, with day 0 defined as date of LCCN diagnosis. Patients who die within 48 hours of the diagnosis will be excluded. | At day 90, 180, 360, with day 0 defined as date of LCCN diagnosis | 90, 180, 360 days |
| Adverse events | Infection, re-hospitalization, transfusion reactions, bleeding diatheses. | 60 days |
| 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 |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001781 |
| Blood Component Removal |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |