Brief Summary

This is a Phase 2 study, open-label, 2-cohort, multicenter, national, interventional in patients with newly diagnosed multiple myeloma. The study will investigate teclistamab (Tec) in combination with lenalidomide (Len) (Tec-Len; Cohort A) or in combination with talquetamab (Tal) (Tec-Tal; Cohort B), allocated based on minimal residual disease (MRD) status (MRD \[-\] \[standard-risk\] vs MRD \[+\] \[high-risk\] respectively). The patient population will consist of adults men and women at least 18 years to younger than 66 years of age, who meet eligibility criteria.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

103

participants targeted

Target at P75+ for phase_2 multiple-myeloma

Timeline

50mo left

Started Jun 2024

Typical duration for phase_2 multiple-myeloma

Geographic Reach

1 country

19 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

6 years study duration

Study Progress31%

Jun 2024Jun 2030

First Submitted

Initial submission to the registry

March 22, 2024

Completed

17 days until next milestone

First Posted

Study publicly available on registry

April 8, 2024

Completed

3 months until next milestone

Study Start

First participant enrolled

June 26, 2024

Completed

3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2028

Expected

2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2030

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

3.8 years

First QC Date

March 22, 2024

Last Update Submit

March 13, 2026

Conditions

Multiple Myeloma

Keywords

Multiple MyelomaNewly DiagnosedTeclistamabTalquetamab

Outcome Measures

Primary Outcomes (2)

Rate of sustained MRD negativity (NGS, 10^-5)
38 months
Rate of conversion from positive MRD to negative MRD (NGS, 10^-5)
38 months

Secondary Outcomes (9)

Number of adverse events
50 months
Rate of sustained MRD negativity (NGS, 10^-6)
38 months
Rate of conversion from positive MRD to negative MRD (NGS, 10^-6).
38 months
Rate of conversion from positive MRD to negative MRD (NGS, 10^-5).
23 months
Number of the death
74 months
+4 more secondary outcomes

Other Outcomes (2)

Percentage of value of biological prognostic factors influencing outcome and response.
38 months
Percentage of score of quality of life
38 months

Study Arms (2)

Teclistamab and Lenalidomide

EXPERIMENTAL

Patients treated with Teclistamab and Lenalidomide for finite duration.

Drug: TeclistamabDrug: LenalidomideDrug: BortezomibDrug: DaratumumabDrug: Dexamethasone

Talquetamab andTeclistamab

EXPERIMENTAL

Patients treated with Teclistamab and Talquetamab for finite duration

Drug: TeclistamabDrug: TalquetamabDrug: LenalidomideDrug: BortezomibDrug: DaratumumabDrug: Dexamethasone

Interventions

TeclistamabDRUG

Maintenance therapy wtih teclistamab (administered via SC injections) for finite duration. Teclistamab will be used in 28 day cycles following initial step up doses