Trial · NCT05147493
A Phase 2 Study of Isatuximab in Combination With Bortezomib, Cyclophosphamide and Dexamethasone Followed by Isatuximab and Lenalidomide Maintenance in Newly Diagnosed Patients With Multiple Myeloma and Severe Renal Impairment
NCT05147493, Phase 2, Unknown, Hellenic Society of Hematology
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 2 Study of Isatuximab in Combination With Bortezomib, Cyclophosphamide and Dexamethasone Followed by Isatuximab and Lenalidomide Maintenance in Newly Diagnosed Patients With Multiple Myeloma and Severe Renal Impairment. Trials, record NCT05147493. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05147493
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Phase 2 Study of Isatuximab in Combination With Bortezomib, Cyclophosphamide and Dexamethasone Followed by Isatuximab and Lenalidomide Maintenance in Newly Diagnosed Patients With Multiple Myeloma and Severe Renal Impairment
- NCT number
- NCT05147493
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 51 participants, estimated
- Lead sponsor
- Hellenic Society of Hematology
- Conditions
- Multiple Myeloma, Renal Impairment, Neoplasms, Plasma Cell, Neoplasms by Histologic Type, Neoplasms, Paraproteinemias, Blood Protein Disorders, Hematologic Diseases
- Interventions
- Isatuximab, Bortezomib, Cyclophosphamide, Dexamethasone, Lenalidomide
- First posted
- 2021-12-07
- Last updated
- 2022-03-29
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Renal Response Rate (RRR) | After six months of treatment with isatuximab plus VCd | The primary endpoint is the renal response rate (RRR) after six months of treatment with isatuximab plus VCd. RRR is defined as the proportion of patients who achieve a partial renal (PRrenal) or better response after six months of treatment with isatuximab plus VCd, using the eGFR cut-off values of the IMWG response criteria |
| Secondary | Overall response rate (ORR) | From study treatment initiation to progressive disease (PD), or initiation of further anti-myeloma treatment, or death, whichever comes first. Maximum time period 36 months | The proportion of patients who achieve a partial response (PR) or better, assessed by the Investigator using the IMWG criteria, from study treatment initiation to progressive disease (PD), or initiation of further anti-myeloma treatment, or death, whichever comes first. |
| Secondary | Progression-free survival (PFS) | From study treatment initiation to progressive disease (PD), or initiation of further anti-myeloma treatment, or death, whichever comes first. Maximum time period 36 months | The time from study treatment initiation to the date of first documentation of PD, assessed by the Investigator using the IMWG response criteria, or initiation of further anti-myeloma treatment, or death from any cause, whichever comes first. |
| Secondary | Time to Response (TTR) | From study treatment initiation to partial response (PR), or better. Maximum time period 36 months | The time from study treatment initiation to the date of the first objective response of partial response (PR) or better, assessed with the IMWG response criteria. |
| Secondary | Duration of Response (DoR) | From time response is achieved to progressive disease (PD), or death, whichever comes first. Maximum time period 36 months | The time from the date of the first objective response to the date of the first documented PD, assessed by the Investigator using the IMWG response criteria, or death, whichever occurs first. DoR will be assessed only for patients who have achieved ≥ partial response (PR) |
| Secondary | Overall Survival (OS) | From study treatment initiation to death. Maximum time period 36 months | The time from study treatment initiation to the date of death from any cause. OS will be assessed during the response follow-up visits until the end of the study. |
| Secondary | Minimal Residual Disease (MRD) negativity | Through study completion. Maximum time period 36 months | The proportion of patients achieving MRD-negative status, assessed by the Investigator at suspected complete response as per IMWG criteria. |
| Secondary | Safety Events i.e. Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs) and serious adverse events (SAEs) | Study treatment initiation until 30 days after last study treatment. Maximum time period 36 months | The incidence of Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs) and serious adverse events (SAEs). |
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/NCT05147493
GET https://conductscience.org/api/trials/v1/NCT05147493/registered