Trial · NCT05298683
A Phase 2 Study of Isatuximab in Combination With Pomalidomide and Dexamethasone in MM Patients Who Received One Prior Line of Therapy Containing Lenalidomide and a Proteasome Inhibitor
NCT05298683, 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 Pomalidomide and Dexamethasone in MM Patients Who Received One Prior Line of Therapy Containing Lenalidomide and a Proteasome Inhibitor. Trials, record NCT05298683. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05298683
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 Pomalidomide and Dexamethasone in MM Patients Who Received One Prior Line of Therapy Containing Lenalidomide and a Proteasome Inhibitor
- NCT number
- NCT05298683
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 108 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, Pomalidomide, Dexamethasone, Acetaminophen (paracetamol), Ranitidine (or equivalent), Diphenhydramine (or equivalent)
- First posted
- 2022-03-28
- Last updated
- 2022-03-28
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | After six months of treatment with isatuximab plus pomalidomide and low-dose dexamethasone | The primary endpoint is the ORR after six months of treatment with isatuximab in combination with pomalidomide, and low-dose dexamethasone. ORR is defined as the proportion of patients with stringent complete response (sCR), complete response (CR), VGPR, and partial response (PR), as assessed by the Investigator using the IMWG response criteria. |
| Secondary | Progression-free Survival | From study treatment initiation to progressive disease (PD), or initiation of further anti-myeloma treatment, or death, whichever occurs first. Maximum time period 42 months. | Defined as the time from study treatment initiation (Cycle 1 Day 1) to the date of first documentation of progressive disease (PD), as assessed by the Investigator using the IMWG response criteria, or the date of death from any cause, or the initiation of further anti-myeloma treatment, or data cut-off, whichever occurs first. |
| Secondary | Overall Survival (OS) | From study treatment initiation to death. Maximum time period 42 months. | Defined as the time from study treatment initiation (Cycle 1 Day 1) to the date of death from any cause. OS will be assessed throughout the treatment period and post EOT during long term follow-up until the end of the study. |
| Secondary | Minimal Residual Response (MRD) | Through study completion. Maximum time 42 months. | Defined as the proportion of patients achieving MRD-negative status, assessed at CR. |
| Secondary | Time to Response (TTR) | From study treatment initiation to partial response (PR), or better. Maximum time period 42 months. | Defined as the time from study treatment initiation (Cycle 1, Day 1) to the date of the first objective response of PR or better. |
| Secondary | Duration of Response (DoR) | From time response is achieved to progressive disease (PD), or death, whichever comes first. Maximum time period 42 months. | Defined as the time from the date of the first response, as determined by the Investigator, to the date of the first PD (based on the International Myeloma Working Group \[IMWG\] response criteria) or death, whichever occurs first. DoR will be determined only for patients who have achieved ≥PR. |
| Secondary | Safety | Study treatment initiation until 30 days after last study treatment. Maximum time period 42 months. | i.e. Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), 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/NCT05298683
GET https://conductscience.org/api/trials/v1/NCT05298683/registered