Multiple MyelomaPhase 2REVIVENCT06100237
Teclistamab in Combination With Daratumumab for High-Risk Smoldering Myeloma: A Clinical and Correlative Phase 2 Immuno-Oncology Study (the REVIVE Study)
A Phase 2 study testing Teclistamab, Talquetamab and Daratumumab SC in people with Multiple Myeloma, run by Carl Ola Landgren, MD, PhD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Teclistamab, Talquetamab and Daratumumab SC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2023to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically or cytologically confirmed smoldering multiple myeloma (SMM) based on the IMWG Criteria10 including:
- 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.)
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- 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.
- 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).
- Because the primary endpoint is MRD negativity based on bone marrow analysis, a patient without measurable disease in blood or urine may be enrolled and assessed for MRD negativity. NOTE: In patients who received minimal prior therapy within the allowable range per exclusion criteria 1, patients should have had documented measurable disease within 4 weeks of starting that respective therapy if currently unmeasurable.
- Patients age ≥18 years.
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0-1 assessed within the past 45 days. (See Appendix 17.1).
- Patients must have adequate organ and marrow function ≤45 days as defined below:
- 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.
- 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.
- 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
- A female participant must be (as defined in Appendix 17.3):
- Not of childbearing potential, or
- Of childbearing potential and practicing at least 1 highly effective method of contraception (see Appendix 17.3). NOTE: Participant must agree to continue the above throughout the study and for 3 months after the last dose of study treatment.
- NOTE: If a woman becomes of childbearing potential after start of the study, the woman must comply with point (b) as described above.
- A female participant must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 3 months after receiving the last dose of study treatment. Female participants should consider preservation of eggs prior to study treatment, as anti-cancer treatments may impair fertility.
- A female participant must agree to not breastfeed during the study and for a period of 5 months after receiving the last dose of study treatment.
- A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and for a period of 3 months after receiving the last dose of study treatment. If the male participant's partner is a female of childbearing potential, the male participant must use condoms (with or without spermicide), and the female partner of the male participant must also be practicing a highly effective method of contraception (see Appendix 17.3).
- NOTE: If the male participant is vasectomized, he still must wear a condom (with or without spermicidal foam/gel/film/cream/suppository), but his female partner is not required to use contraception.
- A male participant must agree not to donate sperm for the purpose of reproduction during the study and for period of 3 months after receiving the last dose of study treatment. Male participants should consider preservation of sperm prior to study treatment, as anti-cancer treatments may impair fertility.
- Ability of the patient to understand and the willingness to sign a written informed consent document.
- Have any condition that, in the opinion of the Investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
- Must be willing and able to adhere to the lifestyle restrictions specified in this protocol (Section 3.3).
Who cannot join
- Patients who have received prior systemic therapies for SMM/MM. One prior cycle (4-5 weeks) of therapy for SMM is allowed provided that patient undergoes a 4-week washout period prior to first dose of study treatment. Treatment with corticosteroids for other indications is permitted.
- Patients who are receiving any other investigational agents for any reasons.
- Patients who receive a live attenuated vaccine within 4 weeks of scheduled study treatment administration.
- Contraindication to any concomitant medication, including those medications administered for infusion reaction, antiviral, antibacterial, anticoagulation, tumor lysis, or hydration prophylaxis given prior to therapy.
- Patient has any of the following:
- Human immunodeficiency virus (HIV)-positive with 1 or more of the following:
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- 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
- 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.
- EXCEPTION: Participants with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination do not need to be tested for HBV DNA by PCR.
- Active hepatitis C infection as measured by positive HCV-ribonucleic acid (RNA) testing.
- Participants with a history of hepatitis C virus (HCV) antibody positivity must undergo HCV-RNA testing (Section 10.3.5.2.2). If a participant with history of chronic hepatitis C infection (defined as both HCV antibody and HCV-RNA positive) completed antiviral therapy and has undetectable HCV-RNA 12 weeks following the completion of therapy, the participant is eligible for the study.
- Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal. Note that FEV1 testing is required for participants with known or suspected of having COPD or asthma, and participants must be excluded if FEV1 <50% of predicted normal.
- Moderate or severe persistent asthma within the past 2 years or uncontrolled asthma of any classification. Note that FEV1 testing is required for participants with known or suspected asthma, and participants must be excluded if FEV1 <50% of predicted normal.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the experimental agents used in study.
- Female patient refuses to discontinue breastfeeding her infant during study treatment or within 5 months after receiving the last dose of study treatment.
- Participant plans to father a child while enrolled in this study or within 3 months after the last dose of study treatment.
- Presence of the following cardiac conditions:
- New York Heart Association stage III or IV congestive heart failure
- Myocardial infarction or coronary artery bypass graft ≤6 months prior to study enrollment
- History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration
- Uncontrolled cardiac arrhythmia or clinically significant electrocardiogram (ECG) abnormalities
- Unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina)
- Uncontrolled intercurrent illness including but not limited to ongoing or active infection, venous thromboembolic disease, hemorrhage, pulmonary fibrosis, pneumonitis, active autoimmune disease or a documented history of autoimmune disease with the exception of vitiligo, type I diabetes, and prior autoimmune thyroiditis that is currently euthyroid based on clinical symptoms and laboratory testing, or psychiatric illness/social situations within 2 weeks that would limit compliance with study requirements.
- Active malignancy other than SMM requiring treatment in the past 24 months. Malignancies treated within the past 24 months that are considered cured with minimal risk of recurrence are allowed.
- Have any condition that, in the opinion of the Investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
- Patients with impaired decision-making capacity will not be enrolled on this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Michelle Armogan, (305) 243-6578, mda182@med.miami.edu
Carl O Landgren, MD, PhD
About this study
Official title: 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
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
- Being tested
- Teclistamab, Talquetamab, Daratumumab SC
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeclistamabDrug
Teclistamab will be administered by subcutaneous (SC) injection per discretion of treating physician. Participants will receive the recommended dosage.
TalquetamabDrug
Talquetamab will be administered per discretion of treating physician. Participants will receive the recommended dosage.
Daratumumab SCDrug
Daratumumab SC will be administered by subcutaneous (SC) injection per discretion of treating physician. Participants will receive the recommended dosage.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Tec-Dara | Experimental | Participants will receive the recommended dosage combination treatment Tec-Dara. Receives: Drug: Teclistamab; Drug: Daratumumab SC |
| Cohort B: Tal-Dara | Experimental | Dosing and treatment schedule for participants in this group will be determined after Cohort A is completed. Receives: Drug: Talquetamab; Drug: Daratumumab SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal Residual Disease (MRD) Negative as Measured by Flow Cytometry
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.
Measured: 12 months
Secondary outcomes (12)
Number of Treatment Related Adverse Events
The number of treatment related serious adverse events (SAEs) and grade 3 or higher adverse events (AEs) in participants receiving protocol therapy will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5, per physician discretion.
Measured: Up to 25 months
Overall Response Rate (ORR)
Overall response rate (ORR) is determined by the number of participants achieving stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) to protocol therapy. Response will be assessed using standard International Myeloma Working Group (IMWG) Criteria for Response in Multiple Myeloma, per physician discretion.
Measured: Up to 24 months
Duration of Response (DoR)
The duration of response (DoR) is measured as the time from when participants meet the criteria for stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) to protocol therapy using International Myeloma Working Group (IMWG) Criteria until the time progressive disease (PD) is documented, per discretion of treating physician.
Measured: Up to 24 months
Best Objective Responses (BoR)
The rate of best objective responses (BoR) is determined by the number of participants who achieve stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) as their best response to protocol therapy using International Myeloma Working Group (IMWG) Criteria, per discretion of treating physician.
Measured: Up to 24 months
Minimal Residual Disease (MRD) Negativity Rate by Next-Generation Sequencing (NGS)
The rate of minimal residual disease (MRD) negativity by next-generation sequencing (NGS) after 24 cycles of the protocol therapy is determined by the number of participants who achieve MRD negativity by 10^-6 sensitivity NGS, per discretion of treating physician.
Measured: Up to 24 months
Sustained MRD Negativity
Sustained MRD negativity is determined by the number of participants who achieve MRD negativity 1, 2, and, 4 years apart, without any positive MRD in between, per discretion of treating physician.
Measured: Up to 7 years
Duration of MRD Negativity
The duration of MRD negativity is measured as the time from the first time participants achieve MRD negativity until the participant has relapsed from MRD negativity, per discretion of treating physician.
Measured: Up to 7 years
Clinical progression-free survival (clinPFS)
Clinical progression-free survival (clinPFS) is measured as the time from the participants start of protocol therapy to the clinical development of symptomatic multiple myeloma or death, per discretion of treating physician.
Measured: Up to 7 years
Biochemical progression-free survival (bioPFS)
Biochemical progression-free survival (bioPFS) is measured as the time from the participants start of protocol therapy to progression of multiple myeloma in the blood or death occurs, using International Myeloma Working Group (IMWG) Criteria, per discretion of treating physician.
Measured: Up to 7 years
Overall Survival (OS)
Overall Survival (OS) is determined by the amount of time from participants start of protocol therapy to death or to last known timepoint the participant was alive.
Measured: Up to 7 years
Serum Concentrations of Teclistamab and Talquetamab
Serum samples will be analyzed to determine concentrations of Teclistamab and Talquetamab using validated, specific, and sensitive methods.
Measured: Up to 7 years
Pharmacokinetics of Teclistamab in multiple myeloma (MM)
Serum from venous blood samples will be collected for measurement of serum concentrations of Teclistamab (Cohort A - Teclistamab only) and the generation of Anti-drug Antibodies (ADAs) where applicable to Teclistamab per the Study Schedule.
Measured: Up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start4 Dec 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carl Ola Landgren, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Responsible party
- Sponsor-investigator, Carl Ola Landgren, MD, PhD, University of Miami
- Investigators
- Carl O Landgren, MD, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100237
- Sponsor's protocol ID
- 20221148
- Acronym
- REVIVE
- Status last verified
- Feb 2026
- First submitted
- 20 Oct 2023
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06100237
- Acronym / sponsor ID
- REVIVE / 20221148
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Carl Ola Landgren, MD, PhDUniversity, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Tec-Dara | Experimental | Drug: Teclistamab, Drug: Daratumumab SCParticipants will receive the recommended dosage combination treatment Tec-Dara. |
| Cohort B: Tal-Dara | Experimental | Drug: Talquetamab, Drug: Daratumumab SCDosing and treatment schedule for participants in this group will be determined after Cohort A is completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (46 listed)
- Patients must have histologically or cytologically confirmed smoldering multiple myeloma (SMM) based on the IMWG Criteria10 including:
- Patients must have measurable disease within the past 4 weeks, which is defined by any one of the following:
- Patients age ≥18 years.
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0-1 assessed within the past 45 days. (See Appendix 17.1).
- Patients must have adequate organ and marrow function ≤45 days as defined below:
Key exclusion criteria (30 listed)
- Patients who have received prior systemic therapies for SMM/MM. One prior cycle (4-5 weeks) of therapy for SMM is allowed provided that patient undergoes a 4-week washout period prior to first dose of study treatment. Treatment with corticosteroids for other indications is permitted.
- Patients who are receiving any other investigational agents for any reasons.
- Patients who receive a live attenuated vaccine within 4 weeks of scheduled study treatment administration.
- Contraindication to any concomitant medication, including those medications administered for infusion reaction, antiviral, antibacterial, anticoagulation, tumor lysis, or hydration prophylaxis given prior to therapy.
- Patient has any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeclistamabTeclistamab will be administered by subcutaneous (SC) injection per discretion of treating physician. Participants will receive the recommended dosage. | Drug | Cohort A: Tec-Dara |
| TalquetamabTalquetamab will be administered per discretion of treating physician. Participants will receive the recommended dosage. | Drug | Cohort B: Tal-Dara |
| Daratumumab SCDaratumumab SC will be administered by subcutaneous (SC) injection per discretion of treating physician. Participants will receive the recommended dosage. | Drug | Cohort A: Tec-Dara, Cohort B: Tal-Dara |
Primary outcome
Minimal Residual Disease (MRD) Negative as Measured by Flow Cytometry
Time frame: 12 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.
12 secondary outcomes
Number of Treatment Related Adverse Events
Time frame: Up to 25 months
Overall Response Rate (ORR)
Time frame: Up to 24 months
Duration of Response (DoR)
Time frame: Up to 24 months
Best Objective Responses (BoR)
Time frame: Up to 24 months
Minimal Residual Disease (MRD) Negativity Rate by Next-Generation Sequencing (NGS)
Time frame: Up to 24 months
Sustained MRD Negativity
Time frame: Up to 7 years
Duration of MRD Negativity
Time frame: Up to 7 years
Clinical progression-free survival (clinPFS)
Time frame: Up to 7 years
Biochemical progression-free survival (bioPFS)
Time frame: Up to 7 years
Overall Survival (OS)
Time frame: Up to 7 years
Serum Concentrations of Teclistamab and Talquetamab
Time frame: Up to 7 years
Pharmacokinetics of Teclistamab in multiple myeloma (MM)
Time frame: Up to 7 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carl O Landgren, MD, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Teclistamab, Talquetamab and Daratumumab SC in people with Multiple Myeloma, run by Carl Ola Landgren, MD, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 46 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Armogan ((305) 243-6578, mda182@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimal Residual Disease (MRD) Negative as Measured by Flow Cytometry (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.