Talquetamab + Teclistamab for Multiple Myeloma

(ROTATE Trial)

Overseen By Carole Ramm

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Noffar Bar

Must be taking: Anti-CD38 antibodies

Must not be taking: Monoclonal antibodies, Cytotoxic, PI, IMiD

Disqualifiers: HIV, Hepatitis B/C, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

Trial Summary

What is the purpose of this trial?

Multiple myeloma is characterized by a pattern of recurrent relapse and remains an incurable malignancy. Participants with minimal residual disease (MRD) after front line therapy with induction with or without transplant have worse prognosis than those with MRD negative disease. Bispecific T-cell-based immunotherapies have the potential to promote further reduction of malignant plasma cells thus improving rates of MRD negativity and improve patient outcomes. In this study, participants who are MRD positive after front line therapy will receive consolidation with GPRC5D-targeted bispecific talquetamab. We will test MRD negative conversion and if MRD negativity was not achieved, the participant will switch to a different target using the B-cell maturation antigen TCE, teclistamab. Consolidation will be continued for up to 1 year in participants who have achieved MRD negativity.

Research Team

Noffar Bar, MD

Principal Investigator

Yale University

Eligibility Criteria

This trial is for individuals with multiple myeloma who still have minimal residual disease (MRD) after initial treatment. It's aimed at those who haven't reached MRD negativity, which means there are still cancer cells detectable even after therapy.

Inclusion Criteria

Must not be progressing as per IMWG criteria

Provision of signed and dated ICF

I am 18 years old or older.

Exclusion Criteria

My heart condition is severe.

Known history, virologic, or serological evidence of hepatitis B or C virus (HBV/HCV) infection

I do not have an active or suspected infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Consolidation Treatment

Participants receive consolidation treatment with GPRC5D-targeted bispecific talquetamab. If MRD negativity is not achieved, switch to B-cell maturation antigen TCE, teclistamab.

12 months

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Safety follow-up visits

Treatment Details

Interventions

• Talquetamab
• Teclistamab

Trial Overview The study tests talquetamab as a consolidation therapy to reduce malignant plasma cells and achieve MRD negativity in patients. If unsuccessful, it switches to teclistamab. The goal is to improve patient outcomes by increasing rates of MRD negativity over a period of up to one year.

Participant Groups

Group I: Arm 1 Experimental Treatment 2 Interventions

Talquetamab is a GPRC5DxCD3 bispecific antibody. It is supplied as a sterile, preservative-free solution for subcutaneous administration. Teclistamab is a BCMAxCD3 bispecific antibody. It is supplied as a sterile, preservative-free solution for subcutaneous administration.

Who Is Running the Clinical Trial?

Noffar Bar

Lead Sponsor

Johnson & Johnson

Industry Sponsor

Trials

116

Recruited

167,000+