NCT05469893

Immuno-PRISM (PRecision Intervention Smoldering Myeloma)

Immuno-PRISM (PRecision Intervention Smoldering Myeloma): A Randomized Phase II Platform Study of Select Immunotherapies for High-Risk Smoldering Myeloma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Irene Ghobrial, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the anti-cancer activity of Teclistamab and to compare it with Lenalidomide + Dexamethasone combination in people with high risk smoldering multiple myeloma. People with smoldering multiple myeloma (SMM) usually do not have symptoms but are at risk for progressing to active multiple myeloma (MM). Multiple Myeloma is a cancer of the plasma cells, which are an important part of the immune system. Patients with active multiple myeloma generally require treatment but there are currently no approved therapies for smoldering multiple myeloma. The names of the study drugs involved in this study are: * Teclistamab * Lenalidomide (also called Revlimid) * Dexamethasone (also called Decadron)

Detailed description

This is a multiple arm, randomized, phase II platform study investigating the efficacy of Teclistamab or other immunotherapies against a control arm of Lenalidomide + Dexamethasone combination in participants with high-risk smoldering multiple myeloma. The names of the study drugs involved in this study are: * Teclistamab * Lenalidomide (also called Revlimid) * Dexamethasone (also called Decadron) Safety of Teclistamab in SMM population will be established by using safety run-in method in the beginning of the study and will enroll up to 6 participants directly into Teclistamab arm. First 3 participants in cohort 1 will receive lower than recommended phase 2 dose (RP2D) of Teclistamab and will be closely observed for the first 28 days. If safety is established with cohort 1, the additional 3participants will be enrolled to cohort 2 to receive RP2D. Once safety run-in participants indicate that it is safe to proceed, additional participants will be randomized 1:2 to the control arm of Lenalidomide + Dexamethasone combination or an investigational single agent (i.e., Teclistamab) arm. 15 participants will be randomized to the control arm, and 30 participants will be randomized to each investigational drug arm. This research study has several different stages: screening, treatment, end of treatment and follow up. The study treatment (either Teclistamab or Lenalidomide + Dexamethasone combination) will continue as long as there is disease benefits from the study drugs or a maximum of 24 months. It is expected that about 51 participants (6 safety + 15 control + 30 investigational arms) will take part in this research study. Teclistamab and Lenalidomide and Dexamethasone are 'investigational' study drugs, which means that they have not been approved for treatment in high-risk smoldering multiple myeloma in the United States by the Food and Drug Administration (FDA).

Conditions

• High-risk Smoldering Multiple Myeloma
• Smoldering Multiple Myeloma
• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Teclistamab	Intravenous (IV) dosage and timing per protocol design
DRUG	Lenalidomide	Oral, dosage and timing per protocol design
DRUG	Dexamethasone	Oral, dosage and timing per protocol design

Timeline

• Start date: 2022-08-10
• Primary completion: 2030-07-31
• Completion: 2030-07-31
• First posted: 2022-07-22
• Last updated: 2025-04-24

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study