NCT05469893

Immuno-PRISM (PRecision Intervention Smoldering Myeloma)

Recruiting now Phase 2 Last updated 24 April 2025

What this trial tests

Phase 2 trial testing Teclistamab in High-risk Smoldering Multiple Myeloma in 52 participants. Currently enrolling.

Timeline

10 August 2022

Primary endpoint
31 July 2030

31 July 2030

Quick facts

Lead sponsor	Irene Ghobrial, MD
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	52
Start date	10 August 2022
Primary completion	31 July 2030
Estimated completion	31 July 2030
Sites	3 locations across United States

Drugs / interventions tested

• Teclistamab (TECLISTAMAB) — full drug profile →
• Lenalidomide — full drug profile →
• Dexamethasone (dexamethasone) — full drug profile →

Conditions studied

• High-risk Smoldering Multiple Myeloma — all drugs for High-risk Smoldering Multiple Myeloma →
• Smoldering Multiple Myeloma — all drugs for Smoldering Multiple Myeloma →
• Multiple Myeloma — all drugs for Multiple Myeloma →

Sponsor

Irene Ghobrial, MD

Who can join

18 and older, any sex, with High-risk Smoldering Multiple Myeloma or Smoldering Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Monitoring, prophylaxis, and treatment of infections in patients with MM receiving bispecific antibody therapy: consensus recommendations from an expert panel.
   Raje N, Anderson K, Einsele H, Efebera Y, et al · · 2023 · cited 120× · PMID 37528088 · DOI 10.1038/s41408-023-00879-7
2. Teclistamab: First Approval.
   Kang C. · · 2022 · cited 70× · PMID 36352205 · DOI 10.1007/s40265-022-01793-1
3. Current use of bispecific antibodies to treat multiple myeloma.
   Lee H, Neri P, Bahlis NJ. · · 2023 · cited 20× · PMID 38066842 · DOI 10.1182/hematology.2023000433
4. Genomic landscape of multiple myeloma and its precursor conditions.
   Alberge JB, Dutta AK, Poletti A, Coorens THH, et al · · 2025 · cited 19× · PMID 40399554 · DOI 10.1038/s41588-025-02196-0
5. Advances and challenges in cancer immunoprevention and immune interception.
   Stanton SE, Castle PE, Finn OJ, Sei S, et al · · 2024 · cited 19× · PMID 38519057 · DOI 10.1136/jitc-2023-007815
6. The consultant's guide to smoldering multiple myeloma.
   Thorsteinsdottir S, Kristinsson SY. · · 2022 · cited 11× · PMID 36485144 · DOI 10.1182/hematology.2022000355
7. Multiple Myeloma: The Role of Autologous Stem Cell Transplantation in the Era of Immunotherapy.
   Rocchi S, Zannetti BA, Marconi G, Lanza F. · · 2024 · cited 10× · PMID 38786075 · DOI 10.3390/cells13100853
8. Bispecific antibodies for the treatment of relapsed/refractory multiple myeloma: updates and future perspectives.
   Parrondo RD, Ailawadhi S, Cerchione C. · · 2024 · cited 10× · PMID 38660139 · DOI 10.3389/fonc.2024.1394048