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Immuno-PRISM (PRecision Intervention Smoldering Myeloma)

NCT05469893 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-04-24

No results posted yet for this study

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)

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    collaborator INDUSTRY

  • Irene Ghobrial, MD

    lead OTHER

Principal Investigators

  • Irene C Ghobrial, MD · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-10
Primary Completion
2030-07-31
Completion
2030-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05469893 on ClinicalTrials.gov