Trial · NCT05066607
Isatuximab Plus Pomalidomide and Dexamethasone Association for Patients With AL Amyloidosis Not in VGPR or Better After Any Previous Therapy
NCT05066607, Phase 2, Unknown, Intergroupe Francophone du Myelome
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Isatuximab Plus Pomalidomide and Dexamethasone Association for Patients With AL Amyloidosis Not in VGPR or Better After Any Previous Therapy. Trials, record NCT05066607. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05066607
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Isatuximab Plus Pomalidomide and Dexamethasone Association for Patients With AL Amyloidosis Not in VGPR or Better After Any Previous Therapy
- NCT number
- NCT05066607
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 46 participants, estimated
- Lead sponsor
- Intergroupe Francophone du Myelome
- Conditions
- AL Amyloidosis
- Interventions
- Isatuximab
- First posted
- 2021-10-04
- Last updated
- 2024-03-06
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hematologic Response | At the end of Cycle 6 (each cycle is 28 days) | To assess hematologic response (VGPR or better i.e. dFLC \< 40 mg/L, CR including modified CR\*, low-dFLC response (dFLC \< 10 mg/L), iFLC \< 10 mg/l) achieved after 6 cycles of Isa-Pd. \*: If iFLC \<ULN and serum and urine immunofixation are negative, then neither a normal uFLC level nor a normal FLC ratio are required for complete response (CR). |
| Secondary | Overall Hematologic Response Rate | At the completion of the 1st, 2nd, 4th, 6th, 9th and 12th cycles (each cycle is 28 days) | To assess in all patients according to their disease history Overall Hematologic Response Rate (VGPR, CR, modified CR\*, Low-dFLC response (dFLC \< 10 mg/L), iFLC \< 10 mg/l and PR) at the completion of the 1st, 2nd, 4th, 6th, 9th and 12th cycles. \*: If iFLC \<ULN and serum and urine immunofixation are negative, then neither a normal uFLC level nor a normal FLC ratio are required for complete response (CR). |
| Secondary | Efficacy Measurement: Progression-free survival (PFS) | During the intervention and at 1 year | Time from the inclusion to either progressive disease or death |
| Secondary | Efficacy Measurement: relapse-free survival (RFS) | During the intervention | To evaluate the relapse-free survival (RFS) |
| Secondary | Efficacy Measurement: Organ response rate (OrRR) | 1 year | To evaluate the Organ response rate at 1 year |
| Secondary | Efficacy Measurement: Overall Survival (OS) | Though study completion, an average of 33 months | Time from initial inclusion to death |
| Secondary | Time to and the duration of haematologic and organ responses | During the intervention | To evaluate the time to and the duration of haematologic and organ responses |
| Secondary | Safety analysis | Until 30 days post last dose of protocol treatment | Rate of adverse events that occured during treatment period |
| Secondary | Cytogenetic: incidence of genetic translocation t(11;14) and impact on hematologic and organ response | Though study completion, an average of 33 months | To assess the impact of t(11.14) determined by Fluorescence In Situ Hybridation (FISH) at inclusion on treatment response. |
| Secondary | Cardiac function | After 6 cycles of IsaPd and at 1 year from start of therapy or 12 cycles of IsaPd (each cycle is 28 days). | To assess the concentration of NT-proBNP level and evaluate the impact of the NT-proBNP level on the strain change. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 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/NCT05066607
GET https://conductscience.org/api/trials/v1/NCT05066607/registered