Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Iberdomide · 7 trials · 6 indications
The rate of minimal residual disease negativity (MRD-negativity) will be reported as the number of participants achieving MRD-negativity after eight cycles of Iber-KDd combination therapy. MRD-negativity is defined as less than one (\<1) residual cancer cell detected in 100,000 cells assessed.
Summarized by a binomial response rate and its associated 2-sided 90% confidence interval (CI) using Pearson-Klopper method.
Assessed per International Myeloma Working Group response criteria (to be done with serum and urine immunologic studies monthly; bone marrow biopsy and repeat imaging at either complete response or progressive disease).
Proportion of patients in each regimen who develop dose limiting toxicity
Rate MRD conversion ( to \<10-5 MM-associated molecules) at completion of consolidation therapy. Patients who are not assessed for MRD at the completion of consolidation (due to any reason, including death, withdrawal from study, loss to follow-up, missed assessment, etc) will be considered as not having achieved MRD conversion.
Estimation of area under the plasma concentration -time curve (AUC) calculated from time zero to time t, where t is the time point of the last measurable concentration
Estimation of AUC calculated from time zero to time t, where t is the time point of the last measurable concentration
Estimation of AUC calculated from time zero extrapolated to infinity
Estimation of AUC calculated from time zero extrapolated to infinity
Estimation of maximum observed plasma concentration
Estimated time to Cmax
Estimated time to Cmax
Estimation of terminal elimination half-life in plasma
Estimation of terminal elimination half-life in plasma
Apparent total plasma clearance when dosed orally
Apparent nonrenal clearance
Estimation of apparent volume of distribution when dosed orally
Renal Clearance
Renal clearance
Estimation of amount excreted in urine
Dialysis clearance
| Arm | Type | Description |
|---|---|---|
| Arm A1: Iberdomide Dose 1 | EXPERIMENTAL | - |
| Arm A2: Iberdomide Dose 2 | EXPERIMENTAL | - |
| Arm A3: Iberdomide Dose 3 | EXPERIMENTAL | - |
| Arm B: Lenalidomide | ACTIVE_COMPARATOR | - |
| Iber-KDd Combination Therapy | EXPERIMENTAL | Prior to Iber-KDd combination therapy, participants will receive Acetaminophen, Diphenhydramine and Montelukast therapy per protocol. Participants will receive up to eight (8) 28-day cycles of combination Iberdomide (I), Carfilzomib (K), Daratumumab (D), and Dexamethasone (d) (Iber-KDd) therapy. Participants will receive Iber-KDd combination therapy for approximately 8 months. In the absence of disease progression, participants will continue on to Iber monotherapy. Participants with disease progression will discontinue study therapy but will continue to be followed for up to three (3) years after conclusion of Iber-KDd combination therapy. |
| Iber Monotherapy | EXPERIMENTAL | After completion of Iber-KDd combination therapy, and In the absence of disease progression, participants will then receive up to twelve (12) 28-day cycles of Iberdomide (Iber) monotherapy. Participants will receive Iber monotherapy for up to 12 months or until disease progression. Participants will be followed for up to three (3) years after conclusion of Iber monotherapy. Total study participation is up to five (5) years. |
| Iberdomide and Daratumumab | EXPERIMENTAL | - |
| Arm A (iberdomide hydrochloride, dexamethasone) | EXPERIMENTAL | Patients receive iberdomide hydrochloride PO QD on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive iberdomide hydrochloride PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Arm B (iberdomide hydrochloride) | ACTIVE_COMPARATOR | Patients receive iberdomide hydrochloride PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Iberdomide, Daratumumab and Dexamethasone (Regimen A) | EXPERIMENTAL | Iberdomide dosed according to cohort assignment days 1-21. Dexamethasone 40 mg oral or intravenously (20 mg for participants 70 or older) on days 1,8,15 and 22 Darartumumab and hyalurnonidase-fihj 1,800mg/30,000 units subcutaneously on days 1,8,15,22 (cycles 1,2) or on days 1,15 (cycles 3-6) |
| Iberdomide, Carfilzomib, Daratumumab and Dexamethasone (Regimen B) | EXPERIMENTAL | Iberdomide dosed according to cohort assignment days 1-21. Dexamethasone 40 mg oral or intravenously (20 mg for participants 70 or older) on days 1,8,15 and 22 Darartumumab and hyalurnonidase-fihj 1,800mg/30,000 units subcutaneously on days 1,8,15,22 (cycles 1,2) or on days 1,15 (cycles 3-6) Carfilzomib dosed intravenously dosed according to cohort assignment on days 1, 8, 15 (Consistent with standard practice, the very first dose of carfilzomib (cycle 1 day 1) must be 20 mg/m\^2). |
| Iberdomide Powder (Fasted), followed by Iberdomide Capsule (Fasted) | EXPERIMENTAL | - |
| Iberdomide Capsule (Fasted), followed by Iberdomide Powder (Fasted) | EXPERIMENTAL | - |
| Iberdomide Powder (Fasted), followed by Iberdomide Powder (Fed) | EXPERIMENTAL | - |
| Iberdomide Powder (Fed), followed by Iberdomide Powder (Fasted) | EXPERIMENTAL | - |
| Group 1: Participants with severe Renal Impairment (RI) | EXPERIMENTAL | Severe Renal Impairment (RI), as defined by an eGFR \< 30 mL/min/1.73 m2 and not requiring dialysis, at screening |
| Group 2: Participants with kidney failure who are on intermittent hemodialysis (IHD) | EXPERIMENTAL | Kidney failure participants on intermittent hemodialysis (IHD) |
| Group 3: Participants with normal renal function | EXPERIMENTAL | Normal renal function, as defined by a creatinine clearance (Clcr) \> 90 mL/min estimated using the Cockcroft-Gault (C-G) equation, at screening. |
| Name | Type | Description |
|---|---|---|
| Iberdomide | DRUG | Specified dose on specified days |
| Lenalidomide | DRUG | Specified dose on specified days |
| Carfilzomib | DRUG | Participants will receive Carfilzomib (K) therapy intravenously (IV) as follows: * Cycle 1: 20 mg/m2 per dose on Day 1; 56 mg/m2 per dose on Days 8 and 15 * Cycles 2 to 8: 56 mg/m2 per dose on Days 1, 8, and 15. |
| Daratumumab | DRUG | Participants will receive Daratumumab (D) therapy subcutaneously (SC) or intravenously (IV) as follows: * Cycles 1 and 2: 1800 mg SC or 16 mg/kg IV on Days 1, 8, 15, and 22 * Cycles 3 through 6: 1800 mg SC or 16 mg/kg IV on Days 1 and 15 * Cycles 7 and 8: 1800 mg SC or 16 mg/kg IV on Day 1. |
| Dexamethasone | DRUG | Participants will receive Dexamethasone (d) therapy either orally (PO) or intravenously (IV) as follows: * Cycles 1 and 2: 40 mg/dose on Days 1, 8, and 15; 20 mg/dose on Day 22 * Cycles 3 and 4: 40 mg/dose on Days 1, 8, and 15 * Cycles 5 through 8: 20 mg/dose on Days 1, 8, and 15. |
| Acetaminophen | DRUG | Participants will receive Acetaminophen orally (PO) prior to Iber-KDd therapy as follows: * Cycles 1 and 2: 650 mg/dose on Days 1, 8, 15, and 22 * Cycles 3 through 6: 650 mg/dose on Days 1 and 15 * Cycles 7 and 8: 650 mg/dose on Day 1. |
| Diphenhydramine | DRUG | Participants will receive Diphenhydramine either orally (PO) or intravenously (IV) prior to Iber-KDd therapy as follows: * Cycles 1 and 2: 25 mg/dose on Days 1, 8, 15, and 22 * Cycles 3 through 6: 25 mg/dose on Days 1 and 15 * Cycles 7 and 8: 25 mg/dose on Day 1. |
| Montelukast | DRUG | Participants will receive Montelukast orally (PO) prior to Iber-KDd as follows: * Cycle 1 only: 10 mg/dose, Days 1, 8, 15, and 22, to be administered prior to the first 4 doses of Daratumumab (D). |
| Daratumumab/rHuPH20 Co-formulation | DRUG | Daratumumab/rHuPH20 will be dosed as follows: * Daratumumab/rHuPH20 1800 mg SC days 1, 8, 15, 22 (28-day cycle; cycles 1-2) * Daratumumab/rHuPH20 1800 mg SC days 1, 15 (28-day cycle; cycles 3-6) * Daratumumab/rHuPH20 1800 mg SC day 1 (28-day cycle; cycles 7-26) |
| Iberdomide Hydrochloride | DRUG | Given PO |
| Quality-of-Life Assessment | OTHER | Ancillary studies |
Inclusion Criteria * Confirmed diagnosis of symptomatic multiple myeloma (MM). * Eastern Cooperative Oncology Group performance status (ECOG) score of 0, 1, or 2. * Received 3 to 6 cycles of an induction therapy that includes a proteasome inhibitor (PI) and immunomodulatory (IMiD) \[eg, bortezomib ...
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