Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant

JRCT ID: jRCT2031220060

Registered date:11/05/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Newly Diagnosed Multiple Myeloma After Transplant
• Date of first enrollment: 03/06/2022
• Target sample size: 760
• Countries of recruitment: India,Japan,Korea, Republic of,Japan,Taiwan,Japan
• Study type: Interventional

Intervention(s)

Drug: Elranatamab
BCMA-CD3 bispecific antibody
Drug: Lenalidomide
Immunomodulatory drug

Outcome(s)

Primary Outcome

Primary Outcome Measures:
Progression Free Survival [ Time Frame: Assessed for up to approximately 5 years ]
Progression Free Survival assessed by Blinded Independent Central review per IMWG response criteria

Secondary Outcome

Secondary Outcome Measures:
1.Overall Survival [ Time Frame: Assessed for up to approximately 5 years ]
Defined as the time from randomization until death due to any cause
2.Minimal Residual Disease negativity rate [ Time Frame: 12 months after randomization ]
Minimal Residual Disease negativity rate per IMWG criteria as assessed via Next Generation Sequencing
3.Sustained MRD negativity rate [ Time Frame: 24 months after randomization ]
Sustained Minimal Residual Disease negativity rate per IMWG criteria as assessed via Next Generation Sequencing
4.Progression Free Survival [ Time Frame: Assessed for up to approximately 5 years ]
Progression Free Survival by investigator per IMWG response criteria

5.Overall minimal residual disease negativity rate [ Time Frame: Assessed for up to approximately 5 years ]
Minimal residual disease negativity rate per IMWG criteria

6.Duration of minimal residual disease negativity [ Time Frame: Assessed for up to approximately 5 years ]
Minimal residual disease negativity per IMWG criteria

7.Sustained minimal residual disease negativity rate [ Time Frame: Assessed for up to approximately 5 years ]
Minimal residual disease negativity per IMWG criteria that has lasted a minimum of 12 months

8.Complete response rate [ Time Frame: Assessed for up to approximately 5 years ]
Complete response rate by blinded independent central review and by investigator per IMWG criteria

9.Duration of complete response [ Time Frame: Assessed for up to approximately 5 years ]
Duration of complete response by blinded independent central review and by investigator per IMWG criteria

10.Frequency of adverse events [ Time Frame: Up to 90 days after last dose ]
Adverse event as characterized by type, frequency, severity per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5, seriousness and relationship to the study intervention

11.Frequency of laboratory abnormalities [ Time Frame: Assessed for up to approximately 5 years ]
12.Pre-dose concentrations of elranatamab [ Time Frame: Assessed for up to approximately 5 years ]
Pharmacokinetics of elranatamab (trough concentrations of elranatamab)

13.Post-dose concentrations of elranatamab [ Time Frame: Assessed for up to approximately 5 years ]
Pharmacokinetics of elranatamab (Post-dose serum concentrations of elranatamab)"

14.Incidence and titers of Anti-Drug Antibody and Neutralizing Antibody against elranatamab [ Time Frame: Assessed for up to approximately 5 years ]
Immunogenicity of elranatamab

15.Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 [ Time Frame: Assessed for up to approximately 5 years ]
Higher scores on the functional scales represent higher levels of functioning. Higher scores on the global health status/quality of life scale represent higher health status/quality of life. Higher scores on symptom scales/items represent a greater presence of symptoms

16.Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20 [ Time Frame: Assessed for up to approximately 5 years ]
Higher scores on the functioning subscales (body image, future perspective) represent higher levels of functioning, whereas higher scores on the symptom subscales (disease symptoms, side effects) represent a greater presence of symptoms

17.Progression Free Survival 2 [ Time Frame: Assessed for up to approximately 5 years ]
Progression Free Survival to the date of second objective disease progression by investigator per IMWG response criteria

Key inclusion & exclusion criteria

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

Include criteria

Inclusion Criteria:
*Diagnosis of MM as defined according to IMWG criteria (Rajkumar, 2014) with measurable disease at diagnosis History of induction therapy for newly diagnosed MM, followed by high dose therapy and autologous stem cell transplant. Randomization must occur within 120 days from the stem cell transplant. For participants who receive consolidation therapy after ASCT, randomization must occur within 60 days of consolidation and within 7 months from ASCT.
*Partial Response or better according to IMWG criteria at the time of randomization
*Must have an archival bone marrow aspirate sample(s) to identify the dominant malignant (index) clone by central laboratory NGS test (ClonoSEQ assay) that is used to track MRD status. This sample should preferably be collected before induction treatment (eg, at diagnosis) or before transplant.
*ECOG performance status <= 1
*Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade <= 1
*Not pregnant and willing to use contraception

Exclude criteria

Exclusion Criteria:
*Plasma cell leukemia
*POEMS syndrome
*Systemic amyloid light chain amyloidosis
*Previous MM maintenance treatment
*Prior treatment with BCMA targeted therapy
*Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
*Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) HBV, HCV, and known HIV or AIDS-related illness
*Previous administration with an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)

Related Information

• Primary Sponsor: Kawai Norisuke
• Secondary ID(s): NCT05317416