Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as CC-220, Iberdomide Hydrochloride, BMS-986382, CC-220 Hydrochloride
Iberdomide · 11 trials · 8 indications
To compare the efficacy of iberdomide (also known as BMS-986382), daratumumab, and dexamethasone (IberDd) to that of daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM) in terms of minimal residual disease (MRD) negative complete response (CR) at any time.
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).
The primary objective is to evaluate the clinical efficacy of three doses of CC-220 (0.45 mg once per day \[QD\], 0.3 mg QD or 0.15 mg QD) compared to placebo, for the treatment of active systemic lupus erythematosus (SLE) using the SLE Responder Index at Week 24 Composite endpoint SRI(4), defined by the following criteria: - Reduction from Baseline of ≥ 4 points in the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2K score and - No new one or more British Isles Lupus Assessment Group (BILAG) A or new (excludes A to B) 2 or more BILAG B items compared to Baseline using BILAG 2004 Index and - No worsening from Baseline defined by an increase of \< 0.30 points from Baseline on a Physician's Global Assessment (PGA) visual analog scale (VAS) from 0-3
A TEAE was defined as any adverse event (AE) that began or worsened on or after the start of IP up to 28 days after the last dose of IP or IP discontinuation date, whichever was later. Each participant was counted once for each applicable category. An IP-related TEAE was defined as a TEAE that the investigator considered to be of suspected relationship to IP. The severity of each adverse event and serious AE (SAE) was assessed by the investigator and graded based on a scale from mild - mild symptoms to severe AEs (non-serious or serious). A serious adverse event (SAE) was any AE which: • Resulted in death • Was life-threatening • Required inpatient hospitalization or prolongation of existing hospitalization • Resulted in persistent or significant disability/incapacity • Was a congenital anomaly/birth defect • Constituted an important medical event.
A TEAE was defined as any adverse event (AE) that began or worsened on or after the start of IP through 28 days after the last dose of IP or IP discontinuation date, whichever was later. Each participant was counted once for each applicable category. An IP-related TEAE was defined as a TEAE that the investigator considered to be of suspected relationship to IP. The severity of each adverse event and serious AE (SAE) was assessed by the investigator and graded based on a scale from mild - mild symptoms to severe AEs (non-serious or serious). A serious adverse event (SAE) was any AE which: • Resulted in death • Was life-threatening • Required inpatient hospitalization or prolongation of existing hospitalization • Resulted in persistent or significant disability/incapacity • Was a congenital anomaly/birth defect • Constituted an important medical event.
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.
Frequency of dose-limiting toxicities (DLT) associated with addition of iberdomide (CC-220) to R-CHOP-21 therapy and the addition of CC-99282 to R-CHOP-21 therapy
Defined as the dose that will be selected for dose expansion based on MTD
AEs evaluated using NCI CTCAE criteria, v. 5.0, including treatment -emergent adverse events (TEAEs) and laboratory assessments
Frequency of DLTs associated with addition of iberdomide (CC-220) to polatuzumab-R-CHP therapy and the addition of CC-99282 to polatuzumab-R-CHP therapy
Defined as the dose that will be selected for dose expansion based on MTD
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
The dose-limiting toxicity (DLT) population includes subjects who missed no more than 4 doses of CC-220, 2 doses of DEX, 1 dose of IV DARA (Cohort E), 1 dose of BTZ (Cohort F), or 1 dose of CFZ (Cohort G1 or G2) during Cycle 1 for reasons other than DLT. This population will be used for analyzing the primary endpoint regarding the determination of the MTD. Hematologic DLTs: Grade 4 neutropenia (ANC \<500/μL for \>5 days) Grade 3 neutropenia (ANC \<1,000/μL) with fever ≥38.5°C Grade 4 thrombocytopenia (platelet count \<25,000/μL) or Grade 3 thrombocytopenia with bleeding or need for platelet transfusion Any other grade 4 hematologic toxicity, except anemia, not resolving to pretreatment baseline within 72 hours. Non-hematologic DLT: Any non-hematological toxicity ≥ Grade 3, except alopecia and nausea controlled by medical management.
Tumor response, including progressive disease (PD) according to the IMWG Uniform Response Criteria (Kumar, 2016) for subjects who achieved partial response (PR) or better.
| 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 | - |
| Daratumumab in combination with Iberdomide and dexamethasone - Dose 1 | EXPERIMENTAL | Participants will receive oral iberdomide, subcutaneous daratumumab and oral dexamethasone. |
| Daratumumab in combination with Iberdomide and dexamethasone - Dose 2 | EXPERIMENTAL | - |
| Daratumumab in combination with Iberdomide and dexamethasone - Dose 3 | EXPERIMENTAL | - |
| Daratumumab in combination with dexamethasone and bortezomib | ACTIVE_COMPARATOR | Participants will receive subcutaneous daratumumab, bortezomib and oral dexamethasone |
| 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. |
| CC-220 0.45 mg QD Placebo Controlled Phase | EXPERIMENTAL | * At Weeks 0 to 24: CC-220 Placebo Controlled Phase: CC-220 0.45 mg once daily (QD) * At Weeks 24 to 52: CC-220 Active Treatment Phase: CC-220 0.45 mg once daily (QD) * Long-term Extension Phase (52 weeks to 104 weeks): At Week 52 all subjects who elect to continue in the Long-term Extension will stay on the same dose they were on at the conclusion of the randomized, double-blind, active treatment phase. |
| C-220 0.3 mg QD Placebo Controlled Phase | EXPERIMENTAL | * At Weeks 0 to 24: CC-220 Placebo Controlled Phase: CC-220 0.3 mg once daily (QD) * At Weeks 24 to 52: CC-220 Active Treatment Phase: CC-220 0.30 mg once daily (QD) * Long-term Extension Phase (52 weeks to 104 weeks): At Week 52 all subjects who elect to continue in the Long-term Extension will stay on the same dose they were on at the conclusion of the randomized, double-blind, active treatment phase. |
| CC-220 0.15 mg QD Placebo Controlled Phase | EXPERIMENTAL | * At Weeks 0 to 24: CC-220 Placebo Controlled Phase: CC-220 0.15 mg once daily (QD) * At Weeks 24 to 52: CC-220 Active Treatment Phase: CC-220 0.15 mg once daily (QD) * Long-term Extension Phase (52 weeks to 104 weeks): At Week 52 all subjects who elect to continue in the Long-term Extension will stay on the same dose they were on at the conclusion of the randomized, double-blind, active treatment phase. |
| Placebo | PLACEBO_COMPARATOR | Weeks 0 to 24: CC-220 Placebo Controlled Phase: placebo once daily (QD) |
| CC-220 0.3mg Every Other Day (QOD) | EXPERIMENTAL | Part 1: CC-220 0.3mg capsules by mouth every other day (QOD) |
| CC-220 0.3mg Every Day (QD) | EXPERIMENTAL | * Part 1: CC-220 0.3mg capsules by mouth every day (QD) * ATEP: CC-220 0.3 mg capsules by mouth every day (QD) |
| CC-220 0.6mg/0.3mg alternating dose QD | EXPERIMENTAL | * Part 1: CC-220 0.6 mg and 0.3mg capsules PO on alternating days * ATEP:CC-220 0.6 mg and 0.3 mg capsules PO on alternating days |
| CC-220 0.6mg QD | EXPERIMENTAL | Part 1: CC-220 0.6mg capsules by mouth QD |
| Placebo QD | PLACEBO_COMPARATOR | Part 1: Identically matching placebo capsules PO QD |
| 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). |
| Administration of CC-220 with R-CHOP-21 | EXPERIMENTAL | CC-220 to be administered orally in combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP-21) for 6 cycles of treatment |
| Administration of CC-99282 with R-CHOP-21 | EXPERIMENTAL | CC-99282 to be administered orally in combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP-21) for 6 cycles of treatment |
| Administration of CC-220 with polatuzumab-R-CHP | EXPERIMENTAL | CC-220 to be administered orally in combination with Polatuzumab vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (polatuzumab-R-CHP) for 6 cycles of treatment |
| Administration of CC-99282 with polatuzumab-R-CHP | EXPERIMENTAL | CC-99282 to be administered orally in combination with Polatuzumab vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (polatuzumab-R-CHP) for 6 cycles of treatment |
| 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. |
| Cohort A: CC-220 Monotherapy - Part 1 | EXPERIMENTAL | Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle |
| Cohort B: CC-220 in combination with Dexamethasone - Part 1 | EXPERIMENTAL | * Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle. * For subjects ≤ 75 years old, oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects \>75 years old, DEX will be administered at 20 mg on Days 1, 8,15, and 22 of each 28-day cycle. Subjects who surpass the age of 75 years while on treatment may be switched to the 20 mg QD dosage based on the investigator's best judgment. |
| Cohort D: CC-220 in combination with Dexamethasone - Part 2 | EXPERIMENTAL | * Oral CC-220 at Recommended Phase 2 dose (RP2D) from Day 1-21 of each 28-day cycle * Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects \>75 years old, DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle. |
| Cohort E: CC-220 with DEX and daratumumab (DARA) - Part 1 | EXPERIMENTAL | * Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle. * Oral DEX for subjects ≤ 75 years old at 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects \>75 years old, oral DEX at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle. * Intravenous DARA at dose 16mg/kg on Days 1, 8, 15, and 22 at cycle 1-2, Days 1, 15 at cycle 3-6, and Day 1 at cycle ≥7 of each 28-day cycle. Once the MTD and/or RP2D is determined in Cohort E (CC-220Dd), subjects will be enrolled at this dose level using SC DARA. * Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle. * Oral DEX for subjects ≤ 75 years old at 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects \>75 years old, oral DEX at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle. * Subcutaneous DARA at dose 1800 mg over 3 to 5 minutes on Days 1, 8, 15, and 22 at cycle 1-2, Days 1, 15 at cycle 3-6, and Day 1 at cycle ≥7 of each 28-day cycle. |
| Cohort F: CC-220 with DEX and bortezomib - Part 1 | EXPERIMENTAL | * Oral CC-220 at dose specified by cohort dose level from Day 1-14 of each 21-day cycle. * Oral DEX for subjects ≤ 75 years old at 40 mg on Days 1, 8, and 15 of each 21-day cycle. For subjects \>75 years old, oral DEX at 20 mg on Days 1, 8, and 15 of each 21-day cycle. * Subcutaneous BTZ at dose 1.3 mg/m\^2 on Days 1, 4, 8 and 11 at cycle 1-8, and Days 1, 8 at cycle ≥9 of each 21-day cycle. |
| Cohort G1-CC-220 in combination with CFZ and DEX -Part 1 | EXPERIMENTAL | * Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle * Intravenous (IV) CFZ (Carfilzomib)administered at a starting dose of 20 mg/m2 on C1D1; and at a dose specified by cohort dose level thereafter on days 1, 8, 15 of each 28-day cycle * Oral DEX (Dexamethasone) on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects ≤ 75 years old, the DEX dose will be 40 mg. For subjects \> 75 years old, the DEX dose will be 20 mg |
| Cohort G2 - CC-220 in combination with CFZ and DEX - Part 1 | EXPERIMENTAL | * Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle * Intravenous (IV) CFZ administered at a starting dose of 20 mg/m2 on C1D1; and at a dose level specified by cohort dose level thereafter Days 1, 2, 8, 9, 15, 16 of each 28-day cycle * Oral DEX on Days 1, 2, 8, 9, 15, 16, 22, 23 of each 28-day cycle. The DEX dose will be 20 mg |
| CohortI-CC-220 in combination with DEX in post BCMA RRMM-Part2 | EXPERIMENTAL | * Oral CC-220 at Recommended Phase 2 dose (RP2D) from Day 1-21 of each 28-day cycle * Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects \>75 years old, oral DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle. |
| CohortJ1:CC-220 in combination with DEX and BTZ in NDMM-Part 2 | EXPERIMENTAL | * Oral CC-220 at Recommended Phase 2 Dose from Day 1-14 of each 21-day cycle (Cycle 1 to 8) and from Day 1-21 of each 28-day cycle (Cycle 9 and above). * Oral DEX at Cycles 1 to 8, 20 mg (≤ 75 years old) or 10 mg (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of each 21-day cycle and Cycles ≥ 9, 40 mg (≤ 75 years old) or 20 mg (\> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle. * Subcutaneous BTZ at dose 1.3 mg/m2 on Days 1, 4, 8 and 11 at Cycle 1-8 of each 21-day cycle. |
| CohortJ2:CC-220 in combination with DEX and BTZ in NDMM-Part 2 | EXPERIMENTAL | * Oral CC-220 at Recommended Phase 2 Dose from Day 1-14 of each 21-day cycle. * Oral DEX at 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) for Cycles 1 to 6 on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. * Subcutaneous BTZ at dose 1.3 mg/m2 on Days 1, 4, 8 and 11 at Cycle 1-6 of each 21-day cycle. |
| Cohort K: CC-220 with DEX and DARA in NDMM and not autologous stem cell transplant eligible - Part 2 | EXPERIMENTAL | Oral CC-220 at 1.0mg, 1.3mg or 1.6mg from Days 1-21 of each 28-day cycle. Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects \>75 years old, oral DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle. Subcutaneous DARA at 1800 mg over 3 to 5minutes on Days 1, 8, 15, and 22 at cycle 1-2 of a 28-day cycle, Days1, and 15 at cycle 3-6 of a 28-day cycle, and Day1 at cycle ≥7 of each 28-day cycle. |
| Name | Type | Description |
|---|---|---|
| Iberdomide | DRUG | Specified dose on specified days |
| Lenalidomide | DRUG | Specified dose on specified days |
| Dexamethasone | DRUG | Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle |
| Daratumumab | DRUG | Subcutaneous Daratumumab 1800mg on Days 1, 8, 15 and 22 for Cycles 1 to 2, on Days 1 and 15 for Cycles 3 to 6, and then on Day 1 for Cycle 7+ of a 28-day cycle |
| Bortezomib | DRUG | Subcutaneous Bortezomib 1.3 mg/m2 on Days 1, 4, 8 and 11 of each 21-day cycle for a total of 8 cycles. |
| 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. |
| 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 |
| CC-220 | DRUG | CC-220 |
| Placebo | OTHER | Placebo QD PO |
| Rituximab | DRUG | Rituximab 375 mg/m2 on Day 1 by intravenous (IV) infusion or 1400 mg (SC) subcutaneous (from Cycle 2) of a 21-day treatment cycle for up to a total of 6 cycles |
| Cyclophosphamide | DRUG | Cyclophosphamide 750mg/m2 on Day 1 by IV infusion of a 21-day treatment cycle for up to a total of 6 cycles |
| Doxorubicin | DRUG | Doxorubicin 50 mg/m2 IV infusion on Day 1 of a 21-day treatment cycle for up to a total of 6 cycles |
| Vincristine | DRUG | Vincristine 1.4 mg/m2 (maximum of 2.0 mg total) IV intravenous on Day 1 of a 21-day treatment cycle for up to a total of 6 cycles |
| Prednisone | DRUG | Prednisone 100 mg PO on Days 1 through 5 of each 21-day treatment or 100mg IV on Day 1 is also acceptable for up to a total of 6 cycles |
| CC-99282 | DRUG | CC-99282 by mouth at the assigned dose starting on Day 1 for 7 consecutive days of the 21-day treatment cycle for 6 cycles of treatment. |
| Polatuzumab vedotin | DRUG | Polatuzumab vedotin 1.8 mg/kg on Day 1 by intravenous (IV) infusion of a 21-day treatment cycle for up to a total of 6 cycles |
| Daratumumab - 16mg/kg | DRUG | Daratumumab (DARA) 16mg/kg by intravenous infusion on Days 1, 8, 15, and 22 at cycle 1-2, Days 1, 15 at cycle 3-6, and Day 1 at cycle ≥7 of each 28-day cycle. |
| Bortezomib (BTZ) | DRUG | Bortezomib 1.3 mg/m\^2 on Days 1, 4, 8 and 11 at cycle 1-8, and Days 1, 8 at cycle ≥9 of each 21-day cycle. |
| Daratumumab- 1800mg | DRUG | Daratumumab (DARA) 1800 mg by subcutaneous injection on Days 1, 8, 15, and 22 at cycle 1-2, Days 1, 15 at cycle 3-6, and Day 1 at cycle ≥7 of each 28-day cycle. |
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 ...
Top 20 of 25 competitors
Iberdomide is an investigational small molecule being developed by Bristol-Myers Squibb Company (ticker BMY). It is being studied in oncology and immunology indications, including multiple myeloma, refractory multiple myeloma, B-cell lymphoma, smoldering plasma cell myeloma, renal insufficiency, and systemic lupus erythematosus. It has not been approved and remains in clinical development.
Iberdomide is being studied for multiple myeloma, including newly diagnosed, relapsed, refractory, and smoldering plasma cell myeloma, as well as B-cell lymphoma, renal insufficiency, and systemic lupus erythematosus. It is investigational and is not approved for any indication. Clinical trials are evaluating it both as maintenance therapy and in combination regimens.
Iberdomide targets CRBN, DDB1, CUL4A, and RBX1. It is a modulator of the cereblon E3 ubiquitin ligase complex, which includes CRBN, DDB1, CUL4A, and RBX1. This target class is described as a modulator, distinguishing it from agents that inhibit or degrade targets directly.
Iberdomide is developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. Bristol-Myers Squibb is the sponsor of the clinical trials evaluating Iberdomide across multiple myeloma, B-cell lymphoma, and systemic lupus erythematosus. The drug is also known by the code CC-220.
Iberdomide is in Phase 1 development according to its overall program status, though individual trials span Phase 1 through Phase 3. It is investigational and has not been approved by the FDA. Five trials have been conducted, with three currently active and two completed, enrolling a total of 2,775 participants.
Iberdomide trials include NCT06107738, a Phase 2 study of Iberdomide and daratumumab maintenance after autologous stem cell transplant; NCT05896228, a Phase 2 study of Iberdomide, daratumumab, carfilzomib, and dexamethasone in relapsed or refractory multiple myeloma; NCT05827016, a Phase 3 comparison of Iberdomide versus lenalidomide maintenance; and NCT05434689, a Phase 1 combination study.
Yes, Iberdomide is also known as CC-220, CC-220 0.03 mg, and Iberdomide Hydrochloride. These names refer to the same investigational compound developed by Bristol-Myers Squibb. Searches for CC-220 lead to the same drug asset as searches for Iberdomide.