Multiple Myeloma, Newly DiagnosedPhase 2NCT06758375
Low Dose Teclistamab in Newly Diagnosed Multiple Myeloma Patients
A Phase 2 study testing Low-dose teclistamab in people with Multiple Myeloma, Newly Diagnosed, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial summary
This single-arm, open-label study aims to determine the efficacy and safety of low-dose, limited-duration teclistamab as a consolidation scheme in newly diagnosed multiple myeloma (NDMM) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Newly Diagnosed
- What is being tested?
- Low-dose teclistamab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteMexico
- Study dates
- 3 Mar 2025to 1 Dec 2026
- 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
- ≥18 years of age.
- Newly diagnosed multiple myeloma.
- Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.
- Women of childbearing potential must have a negative serum pregnancy test prior to starting treatment and agree to use a highly effective method of contraception, such as a hormonal method that inhibits ovulation, an intrauterine device, or a vasectomy partner.
- Males: agree to use a highly effective contraceptive method, such as a male condom or vasectomy.
Who cannot join
- History of previous treatment for MM.
- Active central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma.
- Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes) or AL amyloidosis.
- Severe active infection secondary to viruses, bacteria or fungi.
- Pulmonary disease requiring supplemental oxygen.
- History of allogeneic or autologous hematopoietic cell transplantation.
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- Vaccination with live attenuated virus in the 4 weeks prior to teclistamab administration.
- Major surgery during the 2 weeks prior to the first dose or absence of complete recovery from surgery.
- Presence of other concomitant malignancy.
- Hepatitis B and C virus infection or human immunodeficiency virus (HIV) infection.
- Cerebrovascular events or seizures in the last 6 months.
- Congestive heart failure class III-IV according to NYHA (New York Heart Association Stage).
- Acute myocardial infarction or history of coronary revascularization surgery in the last 6 months.
- Women of childbearing age: active pregnancy prior to the first administration of treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Universitario Dr. Jose E. Gonzalez
Monterrey, Nuevo León, 64460
David Gomez-Almaguer, MD, 528186756718, dgomezalmaguer@gmail.com
About this study
Official title: Low-dose Teclistamab As Consolidation in the First-line Treatment of Patients with Newly Diagnosed Multiple Myeloma.
This single-arm, open-label study aims to determine the efficacy and safety of low-dose, limited-duration teclistamab as a consolidation scheme in newly diagnosed multiple myeloma (NDMM) patients.
Read the detailed description
This single-arm, open-label study aims to determine the efficacy and safety of low-dose (1.0 mg/kg), limited-duration teclistamab as a consolidation scheme in newly diagnosed multiple myeloma (NDMM) patients after 3 (three) VRd cycles as induction therapy.
Patients with MMND who meet the established inclusion criteria will be invited to participate. A single-arm phase 2 study will be conducted in the Hematology Department of the University Hospital, where an induction schedule of 3 cycles of bortezomib, lenalidomide, and dexamethasone (VRd) will be administered followed by consolidation with 4 therapeutic doses of teclistamab at 1.0 mg/kg subcutaneously. Four weeks after the last dose of teclistamab, the clinical response will be assessed according to standard International Myeloma Working Group (IMWG) criteria. Those with a complete response (CR) or better will be assessed for measurable residual disease (MRD) with multiparametric flow cytometry with a sensitivity of 10^6. Patients with CR and negative MRD will be kept under active surveillance for 18 months, while those with positive MRD or high cytogenetic risk will be offered biweekly bortezomib as maintenance. On the other hand, patients with very good partial response (VGPR) or worse will be offered 1-2 additional therapeutic doses of teclistamab and reevaluated 4 weeks after the last dose. Finally, patients who do not achieve CR will exit the study and will continue their management according to the standard of care recommended by their treating physician.
- Conditions
- Multiple Myeloma, Newly Diagnosed
- Being tested
- Low-dose teclistamab
- Keywords
- Multiple myeloma, Teclistamab, Newly diagnosed multiple myeloma, Low-dose teclistamab
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose teclistamabDrug
NDMM patients will receive VRd 3x cicles followed by low dose teclistamab.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Patients receiving 3 cycles of VRd followed by low-dose teclistamab. Receives: Drug: Low-dose teclistamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine general response
Evaluated according to the IMWG response criteria including MRD status.
Measured: 18 months after last teclistamab dose
Secondary outcomes (2)
To determine response duration
Evaluated according to the IMWG response criteria including MRD status.
Measured: Up to 18 months after last teclistamab dose
Adverse events
To report the side effects related to the trial's treatment as per the international guidelines for chemo- and immunotherapy.
Measured: Through the study completion and up to 18 months after last teclistamab dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start3 Mar 2025
- Primary completion7 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple Myeloma, Newly DiagnosedStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- One arm, open-label, phase 2 study
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758375
- Sponsor's protocol ID
- HE24-00015
- Status last verified
- Mar 2025
- First submitted
- 22 Dec 2024
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Girgis S, Lin SXW, Pillarisetti K, Banerjee A, Stephenson T, Ma X, Shetty S, Yang TY, Hilder BW, Jiao Q, Hanna B, Adams HC 3rd, Sun YN, Sharma A, Smit J, Infante JR, Goldberg JD, Elsayed Y. Translational Modeling Predicts Efficacious Therapeutic Dosing Range of Teclistamab for Multiple Myeloma. Target Oncol. 2022 Jul;17(4):433-439. doi: 10.1007/s11523-022-00893-y. Epub 2022 Jun 24.
PubMed 35749004Usmani SZ, Garfall AL, van de Donk NWCJ, Nahi H, San-Miguel JF, Oriol A, Rosinol L, Chari A, Bhutani M, Karlin L, Benboubker L, Pei L, Verona R, Girgis S, Stephenson T, Elsayed Y, Infante J, Goldberg JD, Banerjee A, Mateos MV, Krishnan A. Teclistamab, a B-cell maturation antigen x CD3 bispecific antibody, in patients with relapsed or refractory multiple myeloma (MajesTEC-1): a multicentre, open-label, single-arm, phase 1 study. Lancet. 2021 Aug 21;398(10301):665-674. doi: 10.1016/S0140-6736(21)01338-6. Epub 2021 Aug 10.
PubMed 34388396
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Teclistamab As Consolidation in the First-line Treatment of Patients with Newly Diagnosed Multiple Myeloma.
- ClinicalTrials.gov ID
- NCT06758375
- Acronym / sponsor ID
- HE24-00015
- Conditions
- Multiple Myeloma, Newly Diagnosed
- Keywords
- Multiple myeloma, Teclistamab, Newly diagnosed multiple myeloma, Low-dose teclistamab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 7 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 3 Jan 2025 (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.
This single-arm, open-label study aims to determine the efficacy and safety of low-dose, limited-duration teclistamab as a consolidation scheme in newly diagnosed multiple myeloma (NDMM) patients.
Detailed description
This single-arm, open-label study aims to determine the efficacy and safety of low-dose (1.0 mg/kg), limited-duration teclistamab as a consolidation scheme in newly diagnosed multiple myeloma (NDMM) patients after 3 (three) VRd cycles as induction therapy.
Patients with MMND who meet the established inclusion criteria will be invited to participate. A single-arm phase 2 study will be conducted in the Hematology Department of the University Hospital, where an induction schedule of 3 cycles of bortezomib, lenalidomide, and dexamethasone (VRd) will be administered followed by consolidation with 4 therapeutic doses of teclistamab at 1.0 mg/kg subcutaneously. Four weeks after the last dose of teclistamab, the clinical response will be assessed according to standard International Myeloma Working Group (IMWG) criteria. Those with a complete response (CR) or better will be assessed for measurable residual disease (MRD) with multiparametric flow cytometry with a sensitivity of 10^6. Patients with CR and negative MRD will be kept under active surveillance for 18 months, while those with positive MRD or high cytogenetic risk will be offered biweekly bortezomib as maintenance. On the other hand, patients with very good partial response (VGPR) or worse will be offered 1-2 additional therapeutic doses of teclistamab and reevaluated 4 weeks after the last dose. Finally, patients who do not achieve CR will exit the study and will continue their management according to the standard of care recommended by their treating physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One arm, open-label, phase 2 study
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Low-dose teclistamabPatients receiving 3 cycles of VRd followed by low-dose teclistamab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years of age.
- Newly diagnosed multiple myeloma.
- Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.
- Women of childbearing potential must have a negative serum pregnancy test prior to starting treatment and agree to use a highly effective method of contraception, such as a hormonal method that inhibits ovulation, an intrauterine device, or a vasectomy partner.
- Males: agree to use a highly effective contraceptive method, such as a male condom or vasectomy.
Key exclusion criteria (14 listed)
- History of previous treatment for MM.
- Active central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma.
- Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes) or AL amyloidosis.
- Severe active infection secondary to viruses, bacteria or fungi.
- Pulmonary disease requiring supplemental oxygen.
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 |
|---|---|---|
| Low-dose teclistamabNDMM patients will receive VRd 3x cicles followed by low dose teclistamab. | Drug | Arm 1 |
Primary outcome
To determine general response
Time frame: 18 months after last teclistamab dose
Evaluated according to the IMWG response criteria including MRD status.
2 secondary outcomes
To determine response duration
Time frame: Up to 18 months after last teclistamab dose
Adverse events
Time frame: Through the study completion and up to 18 months after last teclistamab dose
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 20 Mar 2025.
- Background: PubMed 35749004Girgis S, Lin SXW, Pillarisetti K, Banerjee A, Stephenson T, Ma X, Shetty S, Yang TY, Hilder BW, Jiao Q, Hanna B, Adams HC 3rd, Sun YN, Sharma A, Smit J, Infante JR, Goldberg JD, Elsayed Y. Translational Modeling Predicts Efficacious Therapeutic Dosing Range of Teclistamab for Multiple Myeloma. Target Oncol. 2022 Jul;17(4):433-439. doi: 10.1007/s11523-022-00893-y. Epub 2022 Jun 24.
- Background: PubMed 34388396Usmani SZ, Garfall AL, van de Donk NWCJ, Nahi H, San-Miguel JF, Oriol A, Rosinol L, Chari A, Bhutani M, Karlin L, Benboubker L, Pei L, Verona R, Girgis S, Stephenson T, Elsayed Y, Infante J, Goldberg JD, Banerjee A, Mateos MV, Krishnan A. Teclistamab, a B-cell maturation antigen x CD3 bispecific antibody, in patients with relapsed or refractory multiple myeloma (MajesTEC-1): a multicentre, open-label, single-arm, phase 1 study. Lancet. 2021 Aug 21;398(10301):665-674. doi: 10.1016/S0140-6736(21)01338-6. Epub 2021 Aug 10.
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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.
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 Low-dose teclistamab in people with Multiple Myeloma, Newly Diagnosed, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
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 5 inclusion and 14 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 20 Mar 2025. 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 Mexico. 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 David Gomez-Almaguer, MD (528186756718, dgomezalmaguer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine general response (time frame: 18 months after last teclistamab dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06758375, which also lists 2 linked publications.
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 20 Mar 2025.