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A Study to Determine Dose, Safety, Tolerability, Drug Levels, and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Participants With Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CC-220
Dexamethasone
Daratumumab
Bortezomib
Carfilzomib
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Relapsed, Refractory, Pharmacokinetics, Safety, Efficacy, CC-220, Relapsed and refractory multiple myeloma, Dexamethasone, Daratumumab, Bortezomib, Newly diagnosed multiple myeloma, Newly diagnosed multiple myeloma transplant non-eligible

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
  • Relapsed and refractory multiple myeloma (RRMM) participants must have documented disease progression on or within 60 days from the last dose of their last myeloma therapy
  • Newly diagnosed multiple myeloma (NDMM) participants must have documented diagnosis with previously untreated symptomatic multiple myeloma (MM)
  • Participants in Cohorts J1 and K are those for whom autologous stem cell transplantation is not planned for initial therapy or are not considered by the investigator as eligible for high-dose chemotherapy and autologous stem cell transplantation

Exclusion Criteria:

  • Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study
  • Nonsecretory multiple myeloma
  • Prior history of malignancies, other than MM, unless the participant has been free of the disease for ≥ 5 years

Other protocol-defined inclusion/exclusion criteria apply

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort A: CC-220 Monotherapy - Part 1

Cohort B: CC-220 in combination with Dexamethasone (DEX) - Part 1

Cohort D: CC-220 in combination with Dexamethasone - Part 2

Cohort E: CC-220 with DEX and daratumumab (DARA) - Part 1

Cohort F: CC-220 with DEX and bortezomib - Part 1

Cohort G1: CC-220 in combination with CFZ and DEX - Part 1

Cohort G2 - CC-220 in combination with CFZ and DEX - Part 1

Cohort I: CC-220 in combination with DEX in post BCMA RRMM - Part 2

Cohort J1: CC-220 in combination with DEX and BTZ in NDMM - Part 2

Cohort J2: CC-220 in combination with DEX and BTZ in NDMM - Part 2

Cohort K: CC-220 with DEX and DARA in NDMM and not autologous stem cell transplant eligible - Part 2

Cohort C: CC-220 Monotherapy in RRMM - Part 2

Arm Description

Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle

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.

Oral CC-220 at Recommended Phase 2 dose (RP2D) 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

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 a dose of 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.

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, and 8 at cycle ≥9 of each 21-day cycle.

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, and 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

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 C1D2; 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, and 23 of each 28-day cycle. The DEX dose will be 20 mg.

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.

Oral CC-220 at 1.0mg, 1.3mg or 1.6mg administered at cycles 1 to 8 on Days 1 to 14 of each 21-day cycle and cycles ≥ 9 on Days 1 to 21 of each 28-day cycle. 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.

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.

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.

CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle.

Outcomes

Primary Outcome Measures

Establish maximum tolerated doses (MTDs) of CC-220 as monotherapy and in combination with other treatment
Establish the maximum tolerated doses (MTDs) of CC-220 monotherapy, in combination with DEX, and in combination with DEX and daratumumab (CC-220Dd), in combination with DEX and bortezomib (CC-220Vd), and in combination with DEX and carfilzomib (CC-220Kd)
Establish Recommended Phase 2 doses (RP2Ds) of CC-220 as monotherapy and in combination with other treatment
RP2D is defined as the dose selected for phase 2 based on safety, pharmacokinetics and biomarker data from phase 1 of the study
Overall response rate (ORR) of CC-220 in combination with Dexamethasone (DEX) in Cohort D
Tumor response, including progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria (Kumar, 2011) in CC-220 in combination with DEX

Secondary Outcome Measures

Adverse Events (AEs)
Type, frequency, seriousness and severity of adverse events (AEs) (and AEs of special interest) and relationship of AEs to investigational product
Overall response rate (ORR)
Tumor response, including progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria (Kumar, 2016) for subjects who achieved partial response (PR) or better
Time to Response (TTR)
Is defined as the time from the first date of dosing of IP to the first date of documented response (partial response [PR] or greater)
Duration of Response (DOR)
Is defined as Time from the first documentation of response (PR or greater) to the first documentation of Progressive disease (PD)
Progression-free Survival (PFS)
Time from the first dose of investigational product (IP) to the first documentation of PD or death from any cause, whichever occurs first
Overall Survival (OS) in Part 2 relapsed and refractory multiple myeloma (RRMM) cohorts
Time from first dose of IP to death due to any cause
Pharmacokinetics - Area under the plasma concentration-time curve from time zero to tau, where tau is the dosing interval (AUC[TAU])
Pharmacokinetics - Maximum plasma concentration of drug (Cmax)
Pharmacokinetics - Time to maximum plasma concentration of drug (Tmax)
Very good partial response or better rate (VGPR)
Tumor response, including progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria (Kumar, 2016) for subjects who achieved VGPR or better

Full Information

First Posted
May 12, 2016
Last Updated
October 5, 2023
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT02773030
Brief Title
A Study to Determine Dose, Safety, Tolerability, Drug Levels, and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Participants With Multiple Myeloma
Official Title
A Phase 1b/2a Multicenter, Open-label, Dose-escalation Study to Determine the Maximum Tolerated Dose, Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CC-220 as Monotherapy and in Combination With Other Treatments in Subjects With Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 14, 2016 (Actual)
Primary Completion Date
October 15, 2029 (Anticipated)
Study Completion Date
October 15, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a multicenter, multi-country, open-label, Phase 1b/2a dose-escalation study consisting of two parts: dose escalation (Part 1) for CC-220 monotherapy, CC-220 in combination with DEX, CC-220 in combination with DEX and DARA, CC-220 in combination with DEX and BTZ and CC-220 in combination with DEX and CFZ; and the expansion of the RP2D (Part 2) for CC-220 monotherapy and CC-220 in combination with DEX for Relapsed Refractory Multiple Myeloma (RRMM), CC-220 in combination with DEX and BTZ, and CC-220 in combination with DEX and DARA for Newly Diagnosed Multiple Myeloma (NDMM).
Detailed Description
Subjects assigned to CC-220 monotherapy, who develop progressive disease (PD) will have the option to receive DEX in addition to CC-220 after consultation with the Medical Monitor. The dose of CC-220 will not be higher than the dose of CC-220 used in combination with dexamethasone in Cohort B that has been determined to be safe. Progressive disease must be confirmed in accordance with international myeloma working group (IMWG) criteria. For Cohorts A and B, the starting dose level of CC-220, dose level 1, is 0.3 mg. A dose level -1, of 0.15 mg, may also be evaluated if the starting dose level of 0.3 mg for 21 days of a 28-day cycle is not tolerated. For Cohorts E and F, the starting dose level of CC-220, dose level 1, is one dose level below the maximum dose for Cohort B that has been determined to be safe by the dose escalation committee (DEC) at the start of enrollment for both cohorts. For Cohort E in addition to CC-220 and DEX, daratumumab will be administered intravenously (IV) at a 16mg/kg dose. For Cohort F in addition to CC-220 and DEX, bortezomib will be administered subcutaneous (SC) at a 1.3mg/m2 dose. All subjects who discontinue study treatment in Part 1 or Part 2 of the study for a reason other than PD or withdrawal of consent from the study will be followed for response assessment every 28 days (every 21 days for Cohort F) until PD. The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. The initiation of Part 2 will begin when the recommended phase 2 dose (RP2D) is established in Part 1 in either Cohort A, Cohort B, Cohort E or Cohort F. The cohorts may begin once the RP2D is determined for each cohort independently during Part 1. All expansion decisions will be determined by the DEC after review of all safety, PK, biomarker and preliminary efficacy data, as applicable. During Part 2, the Independent Expert Reviewer will review safety data and any other data deemed relevant so that subject safety is ensured.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Relapsed, Refractory, Pharmacokinetics, Safety, Efficacy, CC-220, Relapsed and refractory multiple myeloma, Dexamethasone, Daratumumab, Bortezomib, Newly diagnosed multiple myeloma, Newly diagnosed multiple myeloma transplant non-eligible

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
532 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort A: CC-220 Monotherapy - Part 1
Arm Type
Experimental
Arm Description
Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle
Arm Title
Cohort B: CC-220 in combination with Dexamethasone (DEX) - Part 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort D: CC-220 in combination with Dexamethasone - Part 2
Arm Type
Experimental
Arm Description
Oral CC-220 at Recommended Phase 2 dose (RP2D) 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
Arm Title
Cohort E: CC-220 with DEX and daratumumab (DARA) - Part 1
Arm Type
Experimental
Arm Description
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 a dose of 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.
Arm Title
Cohort F: CC-220 with DEX and bortezomib - Part 1
Arm Type
Experimental
Arm Description
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, and 8 at cycle ≥9 of each 21-day cycle.
Arm Title
Cohort G1: CC-220 in combination with CFZ and DEX - Part 1
Arm Type
Experimental
Arm Description
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, and 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
Arm Title
Cohort G2 - CC-220 in combination with CFZ and DEX - Part 1
Arm Type
Experimental
Arm Description
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 C1D2; 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, and 23 of each 28-day cycle. The DEX dose will be 20 mg.
Arm Title
Cohort I: CC-220 in combination with DEX in post BCMA RRMM - Part 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort J1: CC-220 in combination with DEX and BTZ in NDMM - Part 2
Arm Type
Experimental
Arm Description
Oral CC-220 at 1.0mg, 1.3mg or 1.6mg administered at cycles 1 to 8 on Days 1 to 14 of each 21-day cycle and cycles ≥ 9 on Days 1 to 21 of each 28-day cycle. 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.
Arm Title
Cohort J2: CC-220 in combination with DEX and BTZ in NDMM - Part 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort K: CC-220 with DEX and DARA in NDMM and not autologous stem cell transplant eligible - Part 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort C: CC-220 Monotherapy in RRMM - Part 2
Arm Type
Experimental
Arm Description
CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
CC-220
Other Intervention Name(s)
Iberdomide
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Decadron
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Daratumumab
Other Intervention Name(s)
Darzalex
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
Velcade
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Carfilzomib
Other Intervention Name(s)
Kyprolis
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Establish maximum tolerated doses (MTDs) of CC-220 as monotherapy and in combination with other treatment
Description
Establish the maximum tolerated doses (MTDs) of CC-220 monotherapy, in combination with DEX, and in combination with DEX and daratumumab (CC-220Dd), in combination with DEX and bortezomib (CC-220Vd), and in combination with DEX and carfilzomib (CC-220Kd)
Time Frame
Approximately 3 years
Title
Establish Recommended Phase 2 doses (RP2Ds) of CC-220 as monotherapy and in combination with other treatment
Description
RP2D is defined as the dose selected for phase 2 based on safety, pharmacokinetics and biomarker data from phase 1 of the study
Time Frame
Approximately 3 years
Title
Overall response rate (ORR) of CC-220 in combination with Dexamethasone (DEX) in Cohort D
Description
Tumor response, including progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria (Kumar, 2011) in CC-220 in combination with DEX
Time Frame
Approximately 5 years
Secondary Outcome Measure Information:
Title
Adverse Events (AEs)
Description
Type, frequency, seriousness and severity of adverse events (AEs) (and AEs of special interest) and relationship of AEs to investigational product
Time Frame
Approximately 5 years
Title
Overall response rate (ORR)
Description
Tumor response, including progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria (Kumar, 2016) for subjects who achieved partial response (PR) or better
Time Frame
Approximately 5 years
Title
Time to Response (TTR)
Description
Is defined as the time from the first date of dosing of IP to the first date of documented response (partial response [PR] or greater)
Time Frame
Approximately 5 years
Title
Duration of Response (DOR)
Description
Is defined as Time from the first documentation of response (PR or greater) to the first documentation of Progressive disease (PD)
Time Frame
Approximately 5 years
Title
Progression-free Survival (PFS)
Description
Time from the first dose of investigational product (IP) to the first documentation of PD or death from any cause, whichever occurs first
Time Frame
Approximately 5 years
Title
Overall Survival (OS) in Part 2 relapsed and refractory multiple myeloma (RRMM) cohorts
Description
Time from first dose of IP to death due to any cause
Time Frame
Approximately 5 years
Title
Pharmacokinetics - Area under the plasma concentration-time curve from time zero to tau, where tau is the dosing interval (AUC[TAU])
Time Frame
Approximately 1 year
Title
Pharmacokinetics - Maximum plasma concentration of drug (Cmax)
Time Frame
Approximately 1 year
Title
Pharmacokinetics - Time to maximum plasma concentration of drug (Tmax)
Time Frame
Approximately 1 year
Title
Very good partial response or better rate (VGPR)
Description
Tumor response, including progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria (Kumar, 2016) for subjects who achieved VGPR or better
Time Frame
Approximately 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2 Relapsed and refractory multiple myeloma (RRMM) participants must have documented disease progression on or within 60 days from the last dose of their last myeloma therapy Newly diagnosed multiple myeloma (NDMM) participants must have documented diagnosis with previously untreated symptomatic multiple myeloma (MM) Participants in Cohorts J1 and K are those for whom autologous stem cell transplantation is not planned for initial therapy or are not considered by the investigator as eligible for high-dose chemotherapy and autologous stem cell transplantation Exclusion Criteria: Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study Nonsecretory multiple myeloma Prior history of malignancies, other than MM and select non-invasive malignancies, unless the participant has been free of the disease for ≥ 5 years Other protocol-defined inclusion/exclusion criteria apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 102
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Local Institution - 107
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Local Institution - 101
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Local Institution - 120
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Local Institution - 113
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Local Institution - 106
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Local Institution - 114
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Local Institution - 115
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02117
Country
United States
Facility Name
Local Institution - 110
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Local Institution - 104
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Local Institution - 103
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Local Institution - 140
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Facility Name
Local Institution - 141
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Facility Name
Local Institution - 137
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Local Institution - 138
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
Local Institution - 131
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Local Institution - 139
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Facility Name
Local Institution - 756
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08003
Country
United States
Facility Name
Local Institution - 108
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Local Institution - 122
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Local Institution - 121
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Local Institution - 109
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Local Institution - 111
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Local Institution - 125
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Local Institution - 112
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Local Institution - 117
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Local Institution - 124
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Local Institution - 116
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Local Institution - 123
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Local Institution - 134
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Local Institution - 118
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Local Institution - 119
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112-5550
Country
United States
Facility Name
Local Institution - 126
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Local Institution - 132
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Local Institution - 854
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Local Institution - 852
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Local Institution - 904
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Local Institution - 901
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Local Institution - 902
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Local Institution - 903
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Local Institution - 704
City
Lile Cedax
ZIP/Postal Code
59037
Country
France
Facility Name
Local Institution - 701
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Local Institution - 703
City
Pierre Benite cedex
ZIP/Postal Code
69495
Country
France
Facility Name
Local Institution - 702
City
Poitiers Cedex
ZIP/Postal Code
86021
Country
France
Facility Name
Local Institution - 605
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Local Institution - 603
City
Dusseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Local Institution - 604
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Local Institution - 602
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Local Institution - 601
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Local Institution - 606
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Local Institution - 751
City
Jerusalem
State/Province
Yerushalayim
ZIP/Postal Code
91031
Country
Israel
Facility Name
Local Institution - 754
City
Tel Hashomer
ZIP/Postal Code
52620
Country
Israel
Facility Name
Local Institution - 755
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Local Institution - 307
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Local Institution - 305
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Local Institution - 302
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Facility Name
Local Institution - 303
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Local Institution - 301
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Local Institution - 808
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
790-8524
Country
Japan
Facility Name
Local Institution - 805
City
Aomori
ZIP/Postal Code
030-8553
Country
Japan
Facility Name
Local Institution - 813
City
Hiroshima City
ZIP/Postal Code
730-8619
Country
Japan
Facility Name
Local Institution - 812
City
Isehara City, Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
Local Institution - 809
City
Kamogawa
ZIP/Postal Code
296-8602
Country
Japan
Facility Name
Local Institution - 802
City
Kyoto-city
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Local Institution - 811
City
Nagasaki-shi
ZIP/Postal Code
8528511
Country
Japan
Facility Name
Local Institution - 810
City
Nagoya
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Local Institution - 801
City
Nagoya
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Local Institution - 815
City
Ogaki
ZIP/Postal Code
503-8502
Country
Japan
Facility Name
Local Institution - 804
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Local Institution - 803
City
Sendai
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Local Institution - 806
City
Shinagawa-ku, Tokyo
ZIP/Postal Code
141-8625
Country
Japan
Facility Name
Local Institution - 814
City
Sunto-gun
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Local Institution - 807
City
Toyohashi
ZIP/Postal Code
441-8570
Country
Japan
Facility Name
Local Institution - 503
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Local Institution - 504
City
Maastrich
ZIP/Postal Code
6202 AZ
Country
Netherlands
Facility Name
Local Institution - 501
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
Facility Name
Local Institution - 502
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Local Institution - 404
City
Badalona (Barcelona)
ZIP/Postal Code
08916
Country
Spain
Facility Name
Local Institution - 401
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution - 405
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Local Institution - 408
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Local Institution - 407
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Local Institution - 402
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Local Institution - 406
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Local Institution - 205
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Local Institution - 202
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Local Institution - 204
City
Oxford
ZIP/Postal Code
OX4 6LB
Country
United Kingdom
Facility Name
Local Institution - 201
City
Sutton
ZIP/Postal Code
SM2 5NG
Country
United Kingdom
Facility Name
Local Institution - 203
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
36209764
Citation
Lonial S, Popat R, Hulin C, Jagannath S, Oriol A, Richardson PG, Facon T, Weisel K, Larsen JT, Minnema MC, Abdallah AO, Badros AZ, Knop S, Stadtmauer EA, Cheng Y, Amatangelo M, Chen M, Nguyen TV, Amin A, Peluso T, van de Donk NWCJ. Iberdomide plus dexamethasone in heavily pretreated late-line relapsed or refractory multiple myeloma (CC-220-MM-001): a multicentre, multicohort, open-label, phase 1/2 trial. Lancet Haematol. 2022 Nov;9(11):e822-e832. doi: 10.1016/S2352-3026(22)00290-3. Epub 2022 Oct 6.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
http://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

A Study to Determine Dose, Safety, Tolerability, Drug Levels, and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Participants With Multiple Myeloma

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