Trial · NCT04895917
Daratumumab and Pomalidomide in Previously Treated Patients With AL Amyloidosis
NCT04895917, Phase 2, Terminated, Fondazione IRCCS Policlinico San Matteo di Pavia
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Daratumumab and Pomalidomide in Previously Treated Patients With AL Amyloidosis. Trials, record NCT04895917. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04895917
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Daratumumab and Pomalidomide in Previously Treated Patients With AL Amyloidosis
- NCT number
- NCT04895917
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 27 participants, actual
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Conditions
- AL Amyloidosis
- Interventions
- daratumumab and pomalidomide
- First posted
- 2021-05-20
- Last updated
- 2025-02-20
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of good quality (i.e. CR+VGPR) hematologic response. | 6 months | To assess the rate of good quality (i.e. CR+VGPR) hematologic response at the completion of 6 cycles of Daratumumab plus pomalidomide in patients with relapsed/refractory AL amyloidosis not in VGPR or better after any previous therapy. |
| Secondary | To assess in all patients according to their disease history the overall Hematologic Response Rate (CR, VGPR, LowdFLC partial response and PR) at the completion of 1st and 3rd cycles. | At the end of Cycle 1 and Cycle 3 (each cycle is 28 days) | |
| Secondary | To assess in all patients the overall Hematologic Response Rate including PR at the completion of 6 cycles. | 6 months | |
| Secondary | To assess in all patients duration of hematologic response. After treatment discontinuation, follow-up will be made to the patient every 3 months for at least 1 year. | 1 year after treatment discontinuation | |
| Secondary | To assess in all patients the rate of organ response (i.e. cardiac response: NT-proBNB measurement; renal response: proteinuria measurement) and organ improvement, according to standard criteria (Palladini et al JCO 2012, Palladini et al Blood 2014). | 6 months | |
| Secondary | To assess in all patients the time from the screening to hematologic and organ response. | 6 months | |
| Secondary | To assess in all patients the hematologic disease progression free survival (PFS) from screening and 1-year PFS from screening (months). | 1 year | |
| Secondary | To assess in all patients the overall survival (OS) from screening and 1-year OS from screening (months). | 1 year | |
| Secondary | To assess in all patients the MRD negativity rate according to next generation flow cytometry. | 6 months | |
| Secondary | To assess quality of life (QoL) using EQ5D-5L. | 1 year after treatment discontinuation |
Source ClinicalTrials.gov
Outcomes0
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/NCT04895917
GET https://conductscience.org/api/trials/v1/NCT04895917/registered