NCT06100237

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Carl Ola Landgren, MD, PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Teclistamab	Teclistamab will be administered by subcutaneous (SC) injection per discretion of treating physician. Participants will receive the recommended dosage.
DRUG	Talquetamab	Talquetamab will be administered per discretion of treating physician. Participants will receive the recommended dosage.
DRUG	Daratumumab SC	Daratumumab SC will be administered by subcutaneous (SC) injection per discretion of treating physician. Participants will receive the recommended dosage.

Timeline

• Start date: 2023-12-04
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2023-10-25
• Last updated: 2026-02-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study