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Monoclonal Antibodies

Teclistamab/Talquetamab + Daratumumab for Multiple Myeloma (REVIVE Trial)

Phase 2

Recruiting

Led By Carl O Landgren, MD, PhD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients age ≥18 years

Patients must have histologically or cytologically confirmed smoldering multiple myeloma (SMM) based on the IMWG Criteria10

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 years

Awards & highlights

REVIVE Trial Summary

This trial tests two drug combos to see if they can delay the start of multiple myeloma.

Who is the study for?

This trial is for adults with high-risk smoldering multiple myeloma (SMM) who have not received prior treatments. Participants must be able to perform daily activities with minimal assistance, have good organ and marrow function, and agree to contraception if of childbearing potential. They cannot join if they have severe lung disease, certain heart conditions, active infections or other cancers, autoimmune diseases except some exceptions, or are on investigational drugs.Check my eligibility

What is being tested?

The REVIVE Study is testing whether combining Teclistamab with Daratumumab (Tel-Dara) or Talquetamab with Daratumumab (Tal-Dara) can delay the development of multiple myeloma in patients at high risk. The study will compare these two combination therapies to see which might be more effective.See study design

What are the potential side effects?

Potential side effects may include reactions related to the immune system such as infusion-related reactions and increased risk of infections due to lowered immunity. There could also be effects on blood cell counts leading to anemia or bleeding risks and possible impacts on liver or kidney functions.

REVIVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My condition is confirmed as smoldering multiple myeloma.

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My smoldering multiple myeloma is at high risk of getting worse.

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I agree not to donate sperm during and for 3 months after the study.

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I agree not to breastfeed during and for 5 months after the study.

REVIVE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Minimal Residual Disease (MRD) Negative as Measured by Flow Cytometry

Secondary outcome measures

Best Objective Responses (BoR)

Biochemical progression-free survival (bioPFS)

Clinical progression-free survival (clinPFS)

+9 more

REVIVE Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort B: Tal-DaraExperimental Treatment2 Interventions

Dosing and treatment schedule for participants in this group will be determined after Cohort A is completed.

Group II: Cohort A: Tec-DaraExperimental Treatment2 Interventions

Participants will receive the recommended dosage combination treatment Tec-Dara.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor

902 Previous Clinical Trials

410,026 Total Patients Enrolled

6 Trials studying Multiple Myeloma

1,367 Patients Enrolled for Multiple Myeloma

Carl Ola Landgren, MD, PhDLead Sponsor

1 Previous Clinical Trials

30 Total Patients Enrolled

1 Trials studying Multiple Myeloma

30 Patients Enrolled for Multiple Myeloma

Janssen Scientific Affairs, LLCIndustry Sponsor

159 Previous Clinical Trials

580,468 Total Patients Enrolled

23 Trials studying Multiple Myeloma

2,046 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does Cohort A: Tec-Dara pose any potential risks to patients?

"Our team has rated the safety profile of Cohort A: Tec-Dara as 2 based on its Phase 2 status and existing data showing some evidence for safety but not efficacy."

Answered by AI

Are there any available slots for participants in this clinical research?

"Data on clinicaltrials.gov states that this trial is not actively seeking patients at present, although it was first posted in November of 2023 and updated last October. Fortunately, 823 other trials are currently accepting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Teclistamab or Talquetamab in Combination With Daratumumab for High-Risk Smoldering Myeloma (REVIVE Study)

Carl Ola Landgren, MD, PhD 2023. "Teclistamab or Talquetamab in Combination With Daratumumab for High-Risk Smoldering Myeloma (REVIVE Study)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06100237.