Multiple MyelomaNCT06483139
Novel Treatments in Improving Renal Outcomes in Light Chain Cast Nephropathy
An observational study of Multiple Myeloma and Light Chain Nephropathy, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Myeloma, Light Chain Nephropathy, Acute Kidney Injury
- What is being tested?
- Plasma exchange and Daratumumab
- Type of treatment
- Surgery or procedure
- How many people
- 549 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2024to 1 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with multiple myeloma and clinically-suspected or biopsy-proven light chain cast nephropathy
Who may be able to join
- Adult (≥18 years old)
- Either a new diagnosis of multiple myeloma confirmed by bone marrow plasmayctosis >10% or acute relapse of multiple myeloma
- Light chain cast nephropathy, with involved light chain >500 mg/L
- Acute kidney injury, defined as ≥1.5-fold rise in SCr from baseline (as defined in study outcomes) or the need for renal replacement therapy (RRT).
- Treated with at least 1 round of plasma exchange within 30 days of diagnosis of cast nephropathy
- Treated with plasma exchange in 2010 or later
Show all 20Show fewer
- Adult (≥18 years old)
- Either a new diagnosis of multiple myeloma confirmed by bone marrow plasmayctosis >10% or acute relapse of multiple myeloma
- Light chain cast nephropathy, with involved light chain >500 mg/L
- Acute kidney injury, defined as ≥1.5-fold rise in SCr from baseline or the need for renal replacement therapy (RRT)
- Exclusion Criteria for Both Plasma Exchange-Treated Patients and Control Patients:
- Patients with end stage kidney disease
- Patients with amyloidosis or monoclonal immunoglobulin deposition disease
- Patients with chronic lymphocytic leukemia, plasma cell leukemia, or Waldenstrom's
- Moribund condition (e.g., patients who died within 48 hours of initiation of plasma exchange)
- Active urinary tract obstruction on renal imaging
- Patients with significant albuminuria (≥2+ on urinary dipstick or >10% fraction on UPEP)
- Patients with other biopsy-proven causes of AKI (non-cast nephropathy lesions)
- Patients who did not receive clone-directed therapy for myeloma
- Patients who received plasma exchange >30 days from the time of diagnosis of cast nephropathy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02130
About this study
Official title: The Effect of Novel Treatments in Improving Renal Outcomes Among Patients With Light Chain Cast Nephropathy
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.
Read the detailed description
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.
- Being tested
- Plasma exchange, Daratumumab
- Medical subject headings
- Multiple Myeloma, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma exchangeProcedure or surgery
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
DaratumumabDrug
Patients treated with daratumumab within 30 days of diagnosis of light chain cast nephropathy
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with plasma exchange | Treated with plasma exchange ithin 30 days of diagnosis of light chain cast nephropathy Receives: Procedure: Plasma exchange | |
| 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 Receives: Drug: Daratumumab | |
| Patients not treated with daratumumab | Patients treated with daratumumab within 30 days of diagnosis of light chain cast nephropathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (8)
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
Measured: 30, 60, 90 days
The proportion of patients with Progressive AKI
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 90, 180, 360 days
Adverse events
Infection, re-hospitalization, transfusion reactions, bleeding diatheses.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Jun 2024
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 549 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen, LP, Baystate Health, Boston Medical Center, Dana-Farber Cancer Institute, Massachusetts General Hospital, Mayo Clinic, M.D. Anderson Cancer Center, Medical University of South Carolina, H. Lee Moffitt Cancer Center and Research Institute, Icahn School of Medicine at Mount Sinai, Northwell Health, Ochsner Health System, Ohio State University, Stanford University, Texas Medical Center, Thomas Jefferson University, University of Alabama at Birmingham, University of California, Los Angeles, University of Chicago, University of Colorado Health, University of Minnesota, University of New Mexico, University of Pennsylvania, University of Pittsburgh, University of Virginia, University of Washington
- Responsible party
- Principal investigator, Shruti Gupta, Brigham and Women's Hospital
- Investigators
- Shruti Gupta, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483139
- Sponsor's protocol ID
- 2021P002205
- Status last verified
- Jul 2026
- First submitted
- 26 Jun 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Novel Treatments in Improving Renal Outcomes Among Patients With Light Chain Cast Nephropathy
- ClinicalTrials.gov ID
- NCT06483139
- Acronym / sponsor ID
- 2021P002205
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 549 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Janssen, LP, Baystate Health, Boston Medical Center, Dana-Farber Cancer Institute, Massachusetts General Hospital, Mayo Clinic, M.D. Anderson Cancer Center, Medical University of South Carolina, H. Lee Moffitt Cancer Center and Research Institute, Icahn School of Medicine at Mount Sinai, Northwell Health, Ochsner Health System, Ohio State University, Stanford University, Texas Medical Center, Thomas Jefferson University, University of Alabama at Birmingham, University of California, Los Angeles, University of Chicago, University of Colorado Health, University of Minnesota, University of New Mexico, University of Pennsylvania, University of Pittsburgh, University of Virginia, University of Washington
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients treated with plasma exchange | – | Procedure: Plasma exchangeTreated 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 | – | Drug: DaratumumabPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with multiple myeloma and clinically-suspected or biopsy-proven light chain cast nephropathy
Key inclusion criteria (20 listed)
- Adult (≥18 years old)
- Either a new diagnosis of multiple myeloma confirmed by bone marrow plasmayctosis >10% or acute relapse of multiple myeloma
- Light chain cast nephropathy, with involved light chain >500 mg/L
- Acute kidney injury, defined as ≥1.5-fold rise in SCr from baseline (as defined in study outcomes) or the need for renal replacement therapy (RRT).
- Treated with at least 1 round of plasma exchange within 30 days of diagnosis of cast nephropathy
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma exchangePatients 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 | Procedure or surgery | Patients treated with plasma exchange |
| DaratumumabPatients treated with daratumumab within 30 days of diagnosis of light chain cast nephropathy | Drug | Patients treated with daratumumab |
Primary outcome
The primary composite outcome is the rate of survival with renal recovery within 90 days from the diagnosis of light chain cast nephropathy.
Time frame: 90 days
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.
8 secondary outcomes
The proportion of patients with Receipt of RRT within 30 days, 60 days, and 90 days following diagnosis of light chain cast nephropathy
Time frame: 30, 60, 90 days
The proportion of patients with Progressive AKI
Time frame: 30, 60, 90 days
Survival to hospital discharge
Time frame: 30 days
Renal function (SCr) at hospital discharge
Time frame: 30 days
Time to first renal recovery
Time frame: 180 days
Kidney recovery
Time frame: 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.
Time frame: 90, 180, 360 days
Adverse events
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shruti Gupta, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma and Light Chain Nephropathy, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary composite outcome is the rate of survival with renal recovery within 90 days from the diagnosis of light chain cast nephropathy. (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.