Use of Elranatamab in Patients With High-risk Smoldering Multiple Myeloma

ConditionSmoldering Multiple Myeloma

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorStichting European Myeloma Network

About this trial

This is a multicenter, single arm, open-label, Phase 2 study in high risk smoldering myeloma patients. The primary objective is to determine the efficacy of Elranatamab in patients with previously untreated high-risk SMM. The key-secondary objective is to determine the safety of Elranatamab in patients with previously untreated high-risk SMM.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

>18 years of age

BMPCs ≥10% and <60%

Presence of at least 2 high risk factors, including

Serum M protein ≥2 g/dL,

Disqualifiers

Previous therapy with any systemic therapy for multiple myeloma.

Increased calcium levels: Corrected serum calcium >1 mg/dL above the ULN or >11 mg/dL

Renal insufficiency: Determined by glomerular filtration rate (GFR) <40 mL/min/1.73 m² (Modification of Diet in Renal Disease [MDRD] Formula) or serum creatinine >2 mg/dL

Anemia (hemoglobin 2 g/dL below lower limit of normal or <10 g/dL or both) transfusion support or concurrent treatment with erythropoietin stimulating agents is not permitted

Trial design

Design model

Single group

Treatments tested in this trial

Elranatamab
Drug
Elranatamab will be administered via a subcutaneous injection (SC)

Treatment groups

50 Participants

are divided into 1 treatment group

Group A: ElranatamabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Complete Remission (CR) rate

Response of CR is defined as participants who achieve a CR or better (CR+sCR) according to IMWG response criteria, during the first 6 cycles of treatment and before a possible early termination of the treatment

Time frame

average 24 weeks

Secondary outcomes

Overall response rate (ORR)

Overall response rate (ORR) is defined as the proportion of participants achieving a confirmed PR or better according to the IMWG response criteria.

Time frame

average 24 weeks

MRD-negative CR (MRD_CR)

MRD-negative CR (MRD\_CR) is defined as the proportion of participants achieving a MRD negativity (at or below the threshold of 10-5 by NGS) and CR or better according to the IMWG response criteria.

Time frame

average 24 weeks

Progression-free survival (PFS)

defined as the time from the date of 1st dose of study drug to the date of first confirmed PD, as defined in the IMWG response criteria, or death due to any cause, whichever occurs first. If the participant is alive and w/o progression disease, the participant's data will be censored at the date of last disease assessment.

Time frame

time from the date of 1st dose to to the date of disease progression or death, assed up to 4 years after last dose

Time to progression (TTP)

Time to progression (TTP) is defined as the time from the date of 1st dose of study drug to the date of first documented PD, as defined in the IMWG response criteria. If the participant is w/o progression disease or die, the participant's data will be censored at the date of last disease assessment.

Time frame

time from the date of 1st dose to progression or death, assed up to 4 years after last dose