The REVIVE Study: Teclistamab or Talquetamab with Daratumumab for High-Risk Smoldering Myeloma
This study, called REVIVE, is looking at whether two different drug combinations can delay the development of multiple myeloma in people with high-risk smoldering multiple myeloma (SMM). You would receive either Teclistamab and Daratumumab, or Talquetamab and Daratumumab. The main goal is to see if these treatments can lead to minimal residual disease (MRD) negativity, meaning very few cancer cells are detectable, after 12 months. We are looking for about 50 participants who are at least 18 years old and meet specific health criteria, such as having a certain level of M-protein in their blood and good kidney function. The current status of this study is unclear.
- Study design
- This is an interventional study with a planned enrollment of 50 participants. It is testing two different drug combinations.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured at 12 months, suggesting follow-up for at least this duration.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06100237
Teclistamab in Combination With Daratumumab for High-Risk Smoldering Myeloma: A Clinical and Correlative Phase 2 Immuno-Oncology Study (the REVIVE Study)
Recruiting
PHASE2Ages 18+InterventionalTreatmentCarl Ola Landgren, MD, PhDInvestigator-initiated
~50 participants
Updated 2026-02-23 on ClinicalTrials.gov
What's tested:TeclistamabTalquetamabDaratumumab SC
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Minimal Residual Disease (MRD) Negative as Measured by Flow Cytometry
Measured over 12 months
Conditions
Where it's being run
1 sites across 1 statesFlorida1
Study leadership
- Carl O Landgren, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Miami
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Serum M-protein ≥3 g/dL and/or BMPCs≥10 % (but \<60%)
Absence of anemia: hemoglobin \>10 g/dL
Absence of renal failure: serum creatinine \<2.0 mg/dL
Absence of hypercalcemia: Calcium \<10.5 mg/dL
Absence of lytic bone lesion on X-ray, CT, or positron emission tomography (PET)/CT and not more than 1 lesion on whole body MRI (NOTE: At the discretion of the Investigator, whole body CT or PET/CT may replace MRI in patients who have a contraindication or who are unable to have MRI performed.)
Involved/uninvolved light chain ratio \<100 (unless involved light chain is ≤10 mg/dL) NOTE: Anemia, renal failure, and hypercalcemia is allowed if deemed unrelated to multiple myeloma (MM), see organ function criteria in point #5 below. 2. Patients must have measurable disease within the past 4 weeks, which is defined by any one of the following:
Serum monoclonal protein ≥ 0.5 g/dL
Urine monoclonal protein \>200 mg/24 hour
Serum immunoglobulin free light chain ≥10 mg/dL AND abnormal kappa/lambda serum free light chain ratio (reference: 0.26-1.65)
Other measurable disease as defined by the International Myeloma Working Group (IMWG).
Exclusion
Absolute neutrophil count (ANC) \>1.0 K cells/μL; At the discretion of the Investigator, patients with an ANC of 0.5 K/μL-1.0 K/μL may also be enrolled if clinically appropriate (eg, patients with a baseline neutropenia that is chronic and/or ethnic neutropenia and that does not cause complications, e.g, no history of chronic infections).
Platelet count \>75 K cells/μL
Hemoglobin \>8 g/dL (transfusions are permissible if the cause of the anemia is other than myeloma)
Total bilirubin \<1.5 X upper limit of normal (ULN). NOTE: Isolated total bilirubin ≥1.5 X ULN with conjugated \[direct\] bilirubin \<1.5 X ULN is allowed for those participants with known Gilbert's syndrome.
Aspartate aminotransferase (AST)/ alanine transaminase (ALT) ≤2.5 X ULN
≥30 mL/min based on Modification of Diet in Renal Disease (MDRD) 4-variable Formula calculation (Appendix 17.2) or creatine clearance (CrCl) measured by a 24-hour urine collection. The estimated glomerular filtration rate (eGFR) may also be determined by using other widely accepted methods as clinically indicated, ie, Cockcroft-Gault method or the chronic kidney disease (CKD)-epidemiology collaboration (EPI) per institutional standards. 6. Patients must have SMM that is categorized as high-risk for progression to MM-related end- organ damage by both clinical and genomic characteristics. Patients may be categorized as high risk by the Program for Study and Treatment of Malignant Hemopathies (PETHEMA) (immunoparesis and ≥95% aberrant bone marrow plasma cells (aBMPCs) by flow) and/or Mayo Clinic78 (20/2/20) criteria and/or have clonal BMPCs ≥10% with any one or more of the following criteria4:
Serum M protein ≥3 g/dL
Immunoglobulin A (IgA) SMM
Immunoparesis with reduction of 2 uninvolved immunoglobulin isotypes
Serum involved/uninvolved free light chain (FLC) ratio ≥8 (but \<100)
Progressive increase in M-protein level (evolving type of SMM; increase in serum M- protein by ≥25% on 2 successive evaluations within a 6-month period)
Clonal bone marrow plasma cells (BMPC) 50%-59%
Abnormal plasma cell (PC) immunophenotype (≥95% of BMPCs are clonal) and reduction of ≥1 uninvolved immunoglobulin isotype(s)
Chromosomal abnormalities specifically translocation of chromosomes 4 or 14 (t(4;14)) or deletion of the short arm of chromosome 17 del(17p)) or gain of the long arm of chromosome 1 (1q gain) found in ≥5% of cells
Increased circulating PCs (PCs \>5 x 106/L and/or \>5% PCs per 100 peripheral blood mononuclear cells (PBMCs)
MRI with diffuse abnormalities or 1 focal lesion, AND/OR PET-CT with focal lesion with increased uptake without underlying osteolytic bone destruction. 7. A female participant of childbearing potential must have a negative serum or urine pregnancy test at screening (at or within 45 days of study enrollment) and within 72 hours of the start of study treatment (Section 4.7) and must agree to further serum or urine pregnancy tests during the study 8. A female participant must be (as defined in Appendix 17.3):
History of acquired immune deficiency syndrome (AIDS)-defining conditions cluster of differentiation (CD4)count \<350 cells/mm3
Detectable viral load during screening or within 6 months prior to screening
Not receiving highly active anti-retroviral therapy
Had a change in antiretroviral therapy within 6 months of the start of screening
Receiving antiretroviral therapy that may interfere with study treatment as assessed after discussion with the Medical Monitor 2. Hepatitis B infection (ie, hepatitis B surface antigen (HBsAg) or hepatitis B virus (HBV)- DNA positive). Patients with resolved infection (ie, patients who are HBsAg negative but positive for antibodies to hepatitis B core antigen (anti-HBc) and/or antibodies to hepatitis B surface antigen \[anti-HBs\]) must be screened using real-time polymerase chain reaction (PCR) measurement of HBV DNA levels. Those who are PCR positive will be excluded. In the event the infection status is unclear, quantitative viral levels are necessary to determine the infection status; see Section 10.3.5.2.1 for further required assessments.
What this trial measures
- Minimal Residual Disease (MRD) Negative as Measured by Flow Cytometry12 months
MRD negative (10\^-5 sensitivity by flow cytometry) as best response by completion of 12 cycles. MRD negative result means no disease is detected after treatment. Status of MRD will be assessed using International Myeloma Working Group (IMWG) Consensus Criteria for Response and Minimal Residual Disease Assessment in Multiple Myeloma, per discretion of treating physician.