RecruitingPhase 2NCT06100237

Teclistamab in Combination With Daratumumab for High-Risk Smoldering Myeloma: A Clinical and Correlative Phase 2 Immuno-Oncology Study (the REVIVE Study)

Teclistamab or Talquetamab in Combination With Daratumumab SC for High-Risk Smoldering Myeloma: A Clinical and Correlative Phase 2 Sequential Cohort Immuno-Oncology Study to REVIVE Early Myeloma


Sponsor

Carl Ola Landgren, MD, PhD

Enrollment

50 participants

Start Date

Dec 4, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to see whether combination treatment of Teclistamab and Daratumumab (Tel-Dara) or combination Talquetamab and Daratumumab (Tal-Dara) will delay the onset of multiple myeloma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study — called REVIVE — is testing a combination of two powerful immunotherapy drugs (teclistamab and daratumumab) in people with high-risk smoldering multiple myeloma, which is a pre-cancer blood condition that has a high chance of progressing to full-blown myeloma. The goal is to treat it early and potentially prevent or delay it from becoming active cancer. **You may be eligible if...** - You have been diagnosed with smoldering multiple myeloma (a precancerous plasma cell condition not yet causing organ damage) - Your disease is classified as high-risk based on specific blood, urine, or bone marrow tests - You have not yet been treated with systemic therapy for this condition - Your blood counts, kidneys, calcium, and bone findings meet specific thresholds **You may NOT be eligible if...** - Your myeloma has already caused organ damage (anemia, kidney failure, high calcium, or bone lesions from the cancer) indicating active myeloma - You have already started treatment for myeloma - Your condition doesn't meet the measurable disease criteria required for this study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGTeclistamab

Teclistamab will be administered by subcutaneous (SC) injection per discretion of treating physician. Participants will receive the recommended dosage.

DRUGTalquetamab

Talquetamab will be administered per discretion of treating physician. Participants will receive the recommended dosage.

DRUGDaratumumab SC

Daratumumab SC will be administered by subcutaneous (SC) injection per discretion of treating physician. Participants will receive the recommended dosage.


Locations(1)

University of Miami

Miami, Florida, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06100237


Related Trials