Registered outcomes12

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

1 to 12 of 12

List	Outcome	Time frame	Description
Primary	Dose-limiting Toxicities (DLT) by Age-Frailty Group [Phase Ib]	Assessed continuously during induction cycle 1, up to day 28 + 30 days	DLT is defined as any adverse event (AE) that (a) is at least possibly related to study treatment, (b) occur during cycle 1, and (c) meets the following criteria: Hematologic - grade 4 neutropenia lasting \>5 days despite supportive care (G-CSF allowed), grade ≥3 febrile neutropenia, grade 3 thrombocytopenia with clinically significant bleeding, grade 4 thrombocytopenia unless clearly attributable to underlying disease, and any grade 5 AE; Non-Hematologic - any grade ≥3 AE (except alopecia), uncontrolled nausea, vomiting, or diarrhea not resolving to ≤ grade 1 with medical management, due to toxicity interruption of \>4 doses of iberdomide or \>1 dose of isatuximab or bortezomib (infusion-related reactions excluded), due to toxicity inability to initiate cycle 2 day 1 within 7 days.
Primary	Recommended Phase II Dose (RP2D) of Iberdomide by Age-Frailty Group [Phase Ib]	Assessed continuously during induction cycle 1, up to day 28 + 30 days	The RP2D of iberdomide in combination with fixed doses of isatuximab, bortezomib and dexamethasone is determined by the number of participants experiencing DLT. There are two potential iberdomide dose levels under evaluation including one de-escalation dose. The RP2D is defined as the highest dose at which fewer than 2 of 6 patients experience a DLT.
Primary	Complete Response (CR) or Better Rate by Age-Frailty Group [Phase II]	Assessed on day 1 of each cycle over 8 induction cycles (cycle duration=4 weeks), up to 32 weeks.	CR or better rate is defined as the proportion of participants who achieve a complete response (CR) or stringent CR (sCR) during induction therapy, according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC).
Secondary	Induction Grade 3 or 4 Treatment-Related Adverse Event (TRAE) Rate by Age-Frailty Group [Phase Ib]	Assessed continuously during induction cycles 1-8 (cycle duration=4 weeks), up to 32 weeks + 30 days.	Induction grade 3 or 4 TRAE rate is defined as the proportion of participants who experience a grade 3 or 4 AE based on Common Toxicity Criteria for Adverse Events version 5 (CTCAEv5) with a treatment attribution of possible, probable or definite during induction.
Secondary	Induction Best Response by Age-Frailty Group [Phase II]	Assessed day 1 of each cycle during induction cycles 1-8 (cycle duration=4 weeks), up to 32 weeks.	Best response over induction will be assessed according to the IMWG-URC including sCR, CR, VGPR, PR, MR, SD or PD.
Secondary	Maintenance Best Response by Age-Frailty Risk Group [Phase II]	Assessed day 1 of each cycle during maintenance cycles 1-36 (cycle duration=4 weeks), up to 144 weeks.	Best response over maintenance will be assessed according to the IMWG-URC including sCR, CR, VGPR, PR, MR, SD or PD.
Secondary	Induction Minimal Residual Disease (MRD) Negativity Rate by Age-Frailty Group [Phase II]	Assessed after induction cycle 8 (cycle duration=4 weeks), at 32 weeks.	Induction MRD-negative rate is defined as the proportion of participants achieving MRD negativity, as assessed by next-generation sequencing (NGS) or next-generation flow cytometry (NGF) with sensitivity of \>1 in 10-5 nucleated cells, according to the IMWG-URC.
Secondary	Induction Feasibility Rate by Age-Frailty Group [Phase II]	Assessed after induction cycle 8 (cycle duration=4 weeks), at 32 weeks plus 30 days.	Induction feasibility rate is defined as the proportion of participants completing 8 cycles of induction and receiving at least one dose of maintenance treatment.
Secondary	Induction Grade 3 or 4 TRAE Rate by Age-Frailty Group [Phase II]	Assessed continuously during induction cycles 1-8 (cycle duration=4 weeks), up to 32 weeks + 30 days.	Induction grade 3 or 4 TRAE rate is defined as the proportion of participants who experience a grade 3 or 4 AE based on CTCAEv5 with a treatment attribution of possible, probable or definite during induction.
Secondary	Maintenance Grade 3 or 4 TRAE Rate by Age-Frailty Risk Group [Phase II]	Assessed continuously during maintenance cycles 1-36 (cycle duration=4 weeks), up to 144 weeks + 30 days.	Maintenance grade 3 or 4 TRAE rate is defined as the proportion of participants who experience a grade 3 or 4 AE based on CTCAEv5 with a treatment attribution of possible, probable or definite during maintenance.
Secondary	Induction Serious Adverse Event (SAE) Rate by Age-Frailty Group [Phase II]	Assessed continuously during induction cycles 1-8 (cycle duration=4 weeks), up to 32 weeks + 30 days.	Induction SAE is any untoward medical occurrence at any dose during induction that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization (excluding planned hospitalizations), results in persistent or significant disability or incapacity (namely a substantial disruption of normal life functions), is a congenital anomaly or birth defect, or is considered a medically important event.
Secondary	Maintenance SAE Rate by Age-Frailty Risk Group [Phase II]	Assessed continuously during maintenance cycles 1-36 (cycle duration=4 weeks), up to 144 weeks + 30 days.	Maintenance SAE is any untoward medical occurrence at any dose during maintenance that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization (excluding planned hospitalizations), results in persistent or significant disability or incapacity (namely a substantial disruption of normal life functions), is a congenital anomaly or birth defect, or is considered a medically important event.

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

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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