Registered outcomes20

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 20 of 20

List	Outcome	Time frame	Description
Primary	To evaluate the Very Good Partial Response (VGPR) or better rate by the end of two cycles of induction treatment	84 days	To evaluate the Very Good Partial Response (VGPR) or better rate by the end of two cycles of induction treatment, defined as the proportion of patients who have achieved VGPR, according to International Myeloma Working Group (IMWG) criteria, by the end of two cycles of induction treatment.
Secondary	To evaluate complete response (CR) and sCR rate following one year and two years of maintenance therapy.	3.5 years
Secondary	To evaluate overall response rate and rate of very good partial response (VGPR) or better following one year of maintenance therapy.	3.5 years
Secondary	To evaluate time to VGPR or better.	3.5 years
Secondary	To assess negative minimal residual disease (MRD) rate following ASCT and after 1 and 2 years of maintenance treatment.	3.5 years
Secondary	To evaluate clinical outcomes including time to progression (TTP).	3.5 years
Secondary	To evaluate clinical outcomes including progression-free survival (PFS).	3.5 years
Secondary	To evaluate clinical outcomes including overall survival (OS).	3.5 years
Secondary	To evaluate clinical outcomes including duration of response (DOR).	3.5 years
Secondary	To assess the safety of the Isa-RVD treatment regime based on reported adverse events and toxicity.	3.5 years
Secondary	To assess the tolerability of the Isa-RVD treatment regime based on reported adverse events and toxicity.	3.5 years
Secondary	To evaluate stem cell yield after mobilization.	90 days
Other	To evaluate PFS-2 which is defined as time from registration to disease progression or death (from any cause) on next-line therapy.	3.5 years
Other	To evaluate the clinical efficacy of the Isa-RVD treatment regime in high-risk cytogenetic subgroups (defined as del(1p), gain of 1q, del(17p), t(4;14), t(14;16), t(14;20)) based on treatment response.	3.5 years
Other	To explore immune modulatory effects of Isa-RVd through immune profiling (NK, T, and B cells) and T-cell receptor sequencing.	3.5 years
Other	To compare minimal residual disease detection performed by flow cytometry and next generation sequencing.	3.5 years
Other	To evaluate patient-reported outcomes (PROs) via quality of life instruments through questionnaire completed by patients.	3.5 years
Other	To evaluate the duration of and time to sCR and time to CR in the subgroup of non-IgG kappa positive patients.	3.5 years
Other	To evaluate the CR and sCR rate following induction, ASCT and maintenance treatment in the subgroup of non-IgG kappa positive patients.	3.5 years
Other	To evaluate the immunogenicity of Isatuximab.	3.5 years	To be measured using immunoassays.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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GET https://conductscience.org/api/trials/v1/NCT05123131/registered

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