A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma

JRCT ID: jRCT2031230223

Registered date:13/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Multiple Myeloma
• Date of first enrollment: 13/07/2023
• Target sample size: 1216
• Countries of recruitment: Canada,Japan,United States,Japan,Argentina,Japan,Brazil,Japan,Chile,Japan,Colombia,Japan,Mexico,Japan,Austria,Japan,Belgium,Japan,Czech Republic,Japan,Denmark,Japan,Finland,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Italy,Japan,Netherlands,Japan,Poland,Japan,Portugal,Japan,Romania,Japan,Spain,Japan,Sweden,Japan,Israel,Japan,Switzerland,Japan,Turkey,Japan,United Kingdom,Japan,Australia,Japan,China,Japan,Other 5 countries,Japan
• Study type: Interventional

Intervention(s)

Arm A1: Iberdomide Dose 1
Arm A2: Iberdomide Dose 2
Arm A3: Iberdomide Dose 3
Arm B: Lenalidomide
Specified dose on specified days

Outcome(s)

• Primary Outcome: Progression-free survival (PFS) [ Time Frame: Up to 6 years ]

Secondary Outcome

1. Achieving minimal residual disease (MRD) negativity in participants with complete response (CR) or better at 12 (+- 3) months of maintenance treatment [ Time Frame: Up to 6 years ]
2. Overall Survival [ Time Frame: Up to 12 years ]
3. Recommended iberdomide dose for Stage 2 [ Time Frame: Up to 1 year ]
4. Area under the iberdomide plasma concentration-time curve from time zero to tau [ Time Frame: Up to 1 year ]
5. Area under the iberdomide plasma concentration-time curve within a dosing interval AUC (TAU) [ Time Frame: Up to 1 year ]
6. Maximum iberdomide concentration (Cmax) [ Time Frame: Up to 1 year ]
7. Time to maximum iberdomide plasma concentration (Tmax) [ Time Frame: Up to 1 year ]
8. Number of participants with adverse events (AEs) [ Time Frame: Up to 6 years ]
9.Progression-free survival on next line of treatment (PFS2) [ Time Frame: Up to 6 years ]
10.Achieving MRD negativity in participants with CR or better at any time after the date of randomization [ Time Frame: Up to 6 years ]
11. Conversion from MRD positive to MRD negative in participants with CR or better [ Time Frame: Up to 6 years ]
12. Achievement of CR or better and maintaining MRD-negative status in 2 bone marrow aspirate assessments that are a minimum of 6 months or 1 year apart, without any examination showing MRD positive status in between assessments [ Time Frame: Up to 6 years ]
13. Time to progression (TTP) [ Time Frame: Up to 6 years ]
14. Time to next treatment (TTNT) [ Time Frame: Up to 6 years ]
15. Best response achieved prior to progressive disease (PD) [ Time Frame: Up to 6 years ]
16. Patient-reported health-related quality of life (HRQoL) outcomes and multiple myeloma-related symptoms as measured by the European Organization for Research and Treatment of Cancer [EORTC] Quality of Life C30 questionnaire (QLQ-C30) [ Time Frame: Up to 6 years ]
17. Patient-reported HRQoL outcomes and multiple myeloma-related symptoms as measured by the EORTC Quality of Life Multiple Myeloma Module (QLQ-MY20) [ Time Frame: Up to 6 years ]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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 thalidomide and dexamethasone (VTd), lenalidomide, bortezomib and dexamethasone (RVd)] with or without a CD38 monoclonal antibody, or bortezomib, cyclophosphamide, dexamethasone (VCd), and followed by a single or tandem autologous stem cell transplantation (ASCT). Post-stem cell transplant consolidation is permitted
- Participants within 12 months from initiation of induction therapy who achieved at least a partial response (PR) after autologous stem cell transplantation (ASCT) with or without consolidation, according to International Myeloma Working Group (IMWG 2016) criteria

Exclude criteria

- Progressive disease or clinical relapse (as defined by IMWG response criteria) following ASCT with or without consolidation or is not responsive to primary therapy
- Smoldering myeloma, solitary plasmacytoma or nonsecretory myeloma
- Known central nervous system/meningeal involvement of MM
- Prior history of malignancies, other than MM, unless the participant has been free of the disease for >= 5 years

Related Information

• Primary Sponsor: Acosta Jorge