Actively Recruiting
Teclistamab in Combination With Daratumumab for High-Risk Smoldering Myeloma: A Clinical and Correlative Phase 2 Immuno-Oncology Study (the REVIVE Study)
Led by Carl Ola Landgren, MD, PhD · Updated on 2026-02-23
50
Participants Needed
1
Research Sites
317 weeks
Total Duration
On this page
Sponsors
C
Carl Ola Landgren, MD, PhD
Lead Sponsor
J
Janssen Scientific Affairs, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Teclistamab in Combination With Daratumumab for High-Risk Smoldering Myeloma: A Clinical and Correlative Phase 2 Immuno-Oncology Study (the REVIVE Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed smoldering multiple myeloma (SMM) meeting IMWG criteria
- Serum M-protein ≥3 g/dL and/or bone marrow plasma cells 10-59%
- No anemia (hemoglobin >10 g/dL), no renal failure (serum creatinine <2.0 mg/dL), no hypercalcemia (calcium <10.5 mg/dL)
- No lytic bone lesions on X-ray, CT, or PET/CT and not more than 1 lesion on whole body MRI
- Measurable disease within past 4 weeks or assessable for minimal residual disease negativity
- Age 18 years or older
- ECOG performance status 0-1 within past 45 days
- Adequate organ and marrow function as defined by specified blood counts and liver/kidney function
- High-risk SMM categorization by clinical and genomic criteria including PETHEMA, Mayo Clinic, or specified markers
- Negative pregnancy test within 45 days before enrollment and within 72 hours before treatment start for females of childbearing potential
- Females of childbearing potential must use highly effective contraception during study and for 3 months after last dose
- Females must agree not to donate eggs or breastfeed during study and specified periods after treatment
- Male participants must use condoms during study and for 3 months after last dose; partners must use contraception if applicable
- Male participants must agree not to donate sperm during study and for 3 months after last dose
- Ability to understand and sign informed consent
- Willingness to adhere to lifestyle restrictions specified in the protocol
- No condition that would compromise patient well-being or study requirements as judged by investigator
You will not qualify if you...
- Prior systemic therapies for smoldering multiple myeloma or multiple myeloma except one prior cycle with 4-week washout
- Receiving other investigational agents
- Live attenuated vaccine within 4 weeks before study treatment
- Contraindication to medications used for infusion reactions or prophylaxis
- HIV-positive with AIDS-defining conditions, detectable viral load, or not on stable antiretroviral therapy
- Active hepatitis B or positive HBV DNA by PCR; active hepatitis C infection unless cured with undetectable RNA
- COPD with FEV1 <50% predicted normal
- Moderate or severe persistent asthma in past 2 years or uncontrolled asthma
- Allergic reactions to similar compounds as study drugs
- Female refusal to discontinue breastfeeding during study and 5 months after last dose
- Plan to father a child during study or within 3 months after last dose
- Cardiac conditions including NYHA stage III/IV heart failure, recent myocardial infarction, significant arrhythmias, or unstable cardiac disease
- Uncontrolled intercurrent illness including active infection, thromboembolic disease, bleeding, pulmonary fibrosis, active autoimmune disease except specified exceptions, or recent psychiatric illness
- Active malignancy other than smoldering multiple myeloma requiring treatment in past 24 months
- Any condition compromising well-being or study compliance as judged by investigator
- Impaired decision-making capacity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
M
Michelle Armogan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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