IBERDOMIDE for Multiple myeloma

Inclusion criteria

• {"criterion_text":"- CO43923 Master Protocol: Diagnosed with multiple myeloma (MM) per International Myeloma Working Group (IMWG) criteria\n- CO43923 Master Protocol: Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2\n- CO43923 Substudy 1: A current or past diagnosis of MM in the first line or later setting, including maintenance therapy\n- CO43923 Substudy 2 Cevos + Len Treatment: Completion of planned induction therapy and achievement of at least a partial response (PR)\n- CO43923 Substudy 4 Cevostamab+ Iberdomide Treatment: Previously exposed to at least a PI, an IMiD, and an anti-CD38 antibody for the treatment of R/R MM for whom no suitable SOC therapy options are available"}

Exclusion criteria

• {"criterion_text":"- CO43923 Master Protocol: History of other malignancy within 2 years prior to screening, except those with negligible risk of metastasis or death\n- CO43923 Master Protocol: History of confirmed progressive multifocal leukoencephalopathy\n- CO43923 Master Protocol: Known history of HIV seropositivity\n- CO43923 Substudy 2 Cevos + Len Treatment: Hypersensitivity reactions to lenalidomide or other immunomodulatory drugs\n- CO43923 Substudy 4 Cevostamab+ Iberdomide Treatment: Treatment with systemic immunosuppressive medications including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents within 2 weeks prior to starting pre-phase"}

Primary endpoints

• {"endpoint_text":"- 1. Stage 1: Incidence and severity of adverse events, including dose-limiting toxicities (DLTs), with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0); for cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome(ICANS), severity is determined according to respective American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading Scales\n- 2. Stage 2: ORR, defined as the proportion of patients with a stringent complete response (sCR), CR, very good partial response (VGPR), or partial response (PR)\n- 3. Stage 2: Rate of CR or sCR, defined as proportion of patients achieving a CR or sCR\n- 4. Stage 2: Rate of VGPR or better, defined as the proportion of patients achieving a VGPR or better\n- 5. Stage 2: PFS, defined as the time from initiation of study treatment to the first occurrence of progressive disease or death from any cause (whichever occurs first)\n- 6. Stage 2: OS, defined as the time from initiation of study treatment to death from any cause","definition_or_measurement_approach":"1. Severity of AEs per NCI CTCAE v5.0; CRS and ICANS severity per ASTCT consensus grading scales. 2. ORR = proportion with sCR, CR, VGPR or PR. 3. CR/sCR rate = proportion achieving CR or sCR. 4. VGPR or better = proportion achieving VGPR or better. 5. PFS = time from treatment initiation to first progressive disease or death. 6. OS = time from treatment initiation to death from any cause."}

Secondary endpoints

• {"endpoint_text":"- 1. Stage 1 (maintenance substudies): Conversion to a better response (e.g., from PR to VGPR or better; or from VGPR to CR/sCR or from CR to sCR)\n- 2. Stage 1 (maintenance substudies): PFS, defined as the time from initiation of study treatment to the first occurrence of progressive disease or death from any cause (whichever occurs first)\n- 3. Stage 1 (maintenance substudies): OS, defined as the time from initiation of study treatment to death from any cause\n- 4. Stage 1 (maintenance substudies): MRD negativity rate, defined as proportion of patients who are MRD negative at any time by next-generation sequencing (NGS) on bone marrow aspirate\n- 5. Stage 1 (all other substudies): ORR, defined as the proportion of patients with a sCR, CR, VGPR, or PR\n- 6. Stage 1 (all other substudies): Rate of CR or sCR, defined as proportion of patients achieving a CR or sCR\n- 7. Stage 1 (all other substudies): Rate of VGPR or better, defined as the proportion of patients achieving a VGPR or better\n- 8. Stage 1 (all other substudies): PFS, defined as the time from initiation of study treatment to the first occurrence of progressive disease or death from any cause (whichever occurs first)\n- 9. CO43271 Stage 1 (all other substudies): DOR, defined as the time from the first documented objective response until disease progression or death from any cause, (whichever occurs first)\n- 10. Stage 1 (all other substudies): OS, defined as the time from initiation of study treatment to death from any cause\n- 11. Stage 1 (all other substudies): MRD negativity rate, defined as proportion of patients who are MRD negative at any time by NGS on bone marrow aspirate\n- 12. Stage 1 (all other substudies): Time to first response (for patients who achieve a response of PR or better), defined as time from initiation of study treatment to first achieving a PR or better\n- 13. Stage 1 (all other substudies): Time to best response (for patients who achieve a response of PR or better), defined as time from initiation of study treatment to achieving the deepest response\n- 14. Stage 2: DOR, defined as the time from the first documented objective response until disease progression or death from any cause (whichever occurs first)\n- 15. Stage 2: Time to first response (for patients who achieve a response of PR or better), defined as time from initiation of study treatment to achieving a PR or better\n- 16. Stage 2: Time to best response (for patients who achieve a response of PR or better), defined as time from initiation of study treatment to achieving the deepest response\n- 17. Stage 2: MRD negativity rate, defined as proportion of patients who are MRD negative by NGS on bone marrow aspirate\n- 18. Stage 2: Incidence and severity of adverse events, including DLTs, with severity determined according to NCI CTCAE v5.0; for CRS and ICANS, severity is determined according to ASTCT Consensus Grading Scales","definition_or_measurement_approach":"Secondary endpoints are defined as specified: conversion to better response (categorical), PFS/OS measured as time-to-event from treatment initiation, MRD negativity assessed by NGS on bone marrow aspirate, ORR/CR/sCR/VGPR rates as proportions, DOR as time from first documented objective response to progression or death, time to first/best response as time from treatment initiation to response. AE severity per NCI CTCAE v5.0; CRS/ICANS per ASTCT grading."}

Germany

Earliest CTIS Part Ii Submission Date

20-06-2024

Latest Decision Or Authorization Date

26-07-2024

Processing Time Days

36

Number Of Sites

2

Number Of Participants

12

Poland

Earliest CTIS Part Ii Submission Date

20-06-2024

Latest Decision Or Authorization Date

29-07-2024

Processing Time Days

39

Number Of Sites

4

Number Of Participants

8

Spain

Earliest CTIS Part Ii Submission Date

20-06-2024

Latest Decision Or Authorization Date

23-07-2024

Processing Time Days

33

Number Of Sites

3

Number Of Participants

4

France

Earliest CTIS Part Ii Submission Date

20-06-2024

Latest Decision Or Authorization Date

26-07-2024

Processing Time Days

36

Number Of Sites

4

Number Of Participants

8

Primary sponsor

Full Name

F. Hoffmann-La Roche AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

Bioclinica Inc.

Responsibilities

Medical Imaging

Name

Almac Clinical Technologies LLC

Responsibilities

Codes: 14, 3 (responsibility codes provided in record)

Name

Labcorp Central Laboratory Services SARL

Responsibilities

Code: 4 (responsibility code provided in record)

Name

Q Squared Solutions LLC

Responsibilities

Code: 4 (responsibility code provided in record)

Name

Myriad RBM Inc.

Responsibilities

Code: 4 (responsibility code provided in record)

Name

CellCarta

Responsibilities

Code: 4 (responsibility code provided in record)

Name

Frontage Laboratories Inc.

Responsibilities

Code: 4 (responsibility code provided in record)

Name

Cerba Research

Responsibilities

Code: 4 (responsibility code provided in record)

Third parties

• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Medical Imaging","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Belgium","full_name":"Cerba Research","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Myriad RBM Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}