Trial · NCT07110844
Teclistamab-Daratumumab in AL Amyloidosis
NCT07110844, Phase 2, Recruiting, Rajshekhar Chakraborty, MD
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Teclistamab-Daratumumab in AL Amyloidosis. Trials, record NCT07110844. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07110844
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Teclistamab-Daratumumab in AL Amyloidosis
- NCT number
- NCT07110844
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 25 participants, estimated
- Lead sponsor
- Rajshekhar Chakraborty, MD
- Conditions
- Amyloid Light-chain Amyloidosis
- Interventions
- Teclistamab, Daratumumab and Hyaluronidase-fihj
- First posted
- 2025-08-08
- Last updated
- 2026-07-13
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hematologic Complete Response (Heme-CR) rate | 6 months from treatment initiation | Heme-CR will be defined as: involved free light-chain level less than the upper limit of the normal range with negative serum and urine immunofixation; normalization of the uninvolved free light-chain level or free light-chain ratio will not be required to determine a complete response. |
| Secondary | Minimal Residual Disease (MRD) negativity rate by Free Light Chain Mass Spectrometry (FLC-MS) in serum | 1 month, 3 months, 6 months, and 18 months | Secondary outcome is to assess the rate of minimal residual disease (MRD)-negativity and sustained MRD-negativity with Teclistamab-Daratumumab |
| Secondary | MRD-negativity rate by multiparameter flow cytometry (MFC) in bone marrow | 6 months and 18 months | The MRD-negativity rate by 6 and 18 months will be reported descriptively. |
| Secondary | Time to heme-CR | Day 1 of each cycle, and every 6 weeks after treatment cessation (up to 1 year) | Time to heme-CR will be calculated from the day of treatment initiation (C1D0), and will be reported as median (range). |
| Secondary | Major organ deterioration-progression-free survival (MOD-PFS) rate | From Cycle 2 to Cycle 6 Day 1 (Each cycle is 28 days), End of treatment visit (up to 6 months from treatment initiation), and up to 18 months from treatment initiation | MOD-PFS will be calculated as a time-to-event endpoint using Kaplan-Meier method. |
| Secondary | Overall survival rate | Through study completion, up to 18 months from treatment initiation | Overall survival frequency from initiation of study drug, including cause of death for patients who die on study |
| Secondary | Frequency of Cytokine Release Syndrome (CRS) | Throughout Cycle 1 (each cycle is 28 days), Day 0, Day 1, Day 3, Day 8, Day 15, Day 22; Throughout Cycle 2 and Cycle 6 on Day 1 and Day 15; End of treatment visit (up to 6 months from treatment initiation), Post treatment follow-up (up to 18 months) | Frequency of CRS (all-grade and grade ≥3) events |
| Secondary | Rate of infections | Throughout Cycle 1 (each cycle is 28 days), Day 0, Day 1, Day 3, Day 8, Day 15, Day 22; Throughout Cycle 2 and Cycle 6 on Day 1 and Day 15; End of treatment visit (up to 6 months from treatment initiation), Post treatment follow-up (up to 18 months) | Frequency rate of infections (all-grade and grade ≥3) will be reported descriptively. |
| Secondary | Number of participants with a heart response after treatment | 6 months and 18 months | Heart response is defined as N-terminal pro Brain Natriuretic Peptide (NT-ProBNP) response (\>30% and \>300 ng/l decrease in subjects with baseline NT-proBNP\>650 ng/l) or New York Heart Association (NYHA) class response (\>2 class decrease in subjects with baseline NYHA class 3 or 4) |
| Secondary | Number of No Responses in the heart after treatment | 6 months and 18 months | No response in the heart is defined as ≤30% reduction in NT-proBNP from baseline |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07110844
GET https://conductscience.org/api/trials/v1/NCT07110844/registered?page=2