Multiple Myeloma (MM)Phase 3TiTanNCT07740486
A Study Comparing Treatment With Teclistamab and Talquetamab Versus Daratumumab and Lenalidomide in Patients With Multiple Myeloma After Stem Cell Transplant Who Still Have Detectable Disease
A Phase 3 study testing Teclistamab, Talquetamab and Daratumumab (Subcutaneously) in people with Multiple Myeloma (MM), run by Polish Myeloma Consortium.
Trial summary
Multiple myeloma is a type of blood cancer that can come back even after effective treatment. After high-dose therapy and autologous stem cell transplantation (ASCT), some patients have no visible signs of disease, but small numbers of cancer cells may still remain in the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma (MM)
- What is being tested?
- Teclistamab, Talquetamab and Daratumumab (Subcutaneously)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Apr 2033
- Phase
- Phase 3
- 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
- Documented diagnosis of MM as per IMWG diagnostic criteria.
- Newly diagnosed patients who have completed a single or tandem autologous stem cell transplant after receiving quadruplet induction (containing an anti-CD38 antibody, an immunomodulatory drug, and a proteasome inhibitor). Up to 2 cycles of post-ASCT consolidation are acceptable.
- Patients must have received high-dose chemotherapy and a first ASCT within 12 months from the initiation of induction therapy.
- Patients must be within 6 months of their most recent ASCT, or within 7 months for patients who received consolidation therapy.
- Positive minimal residual disease (at a 10-⁵ threshold) in the bone marrow assessed by NGF after autologous stem cell transplantation (assessed 60 to 150 days after transplantation and after completion of any consolidation therapy, with the assessment used for eligibility performed prior randomization).
- Males or females ≥ 18 years of age
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- Karnofsky performance status score ≥ 50% ( ECOG performance status score of ≤2).
- Adequate hepatic function, with bilirubin ≤ 2.0 x ULN - except in participants with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin ≤ 1.5 ULN is required) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN.
- ANC ≥ 1.0 x 109/L (prior growth factor support is permitted but must be without support for 7 days for G-CSF or GM-CSF or 14 days for pegylated-G-CSF), hemoglobin ≥ 8 g/dL (without red blood cell transfusion in the prior 7 days; recombinant human erythropoietin use is permitted), Platelets ≥75×109/L in patients in whom <50% of bone marrow nucleated cells are plasma cells and ≥50×109/L in patients in whom ≥50% of bone marrow nucleated cells are plasma cells (without transfusion support or thrombopoietin receptor agonist within 7 days before the laboratory test)
- Calculated creatinine clearance (by Cockcroft-Gault) ≥ 30 ml/min or creatinine clearance measured by a 24-hour urine collection.
- Serum calcium corrected for albumin ≤ 14 mg/dl or free ionized calcium <6.5 mg/dL.
- Females of childbearing potential (FCBP) must have 2 negative pregnancy tests (sensitivity of at least 50 mIU/mL) prior to initiating treatment. The first pregnancy test must be performed within 10-14 days before and the second pregnancy test must be performed within 24 hours before the drugs are administered.
- Females of childbearing potential must agree to use a highly effective method of contraception (failure rate <1% per year), preferably with low user dependency, throughout the study treatment period and for at least 6 months after the last dose of study treatment.
- Male participants must agree to use a condom during sexual intercourse with a pregnant woman or a woman of childbearing potential during study treatment and for at least 90 days after the last dose of study treatment. In addition, male participants must ensure that their partner of childbearing potential uses effective contraception, (failure rate <1% per year), preferably with low user dependency, during the same period.
- Voluntary written informed consent.
Who cannot join
- Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the NCI CTCAE Version 5.0.
- COPD with a 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.
- Severe persistent asthma within the past 2 years (see Appendix x[DS2.1] [for severity of Asthma]), uncontrolled asthma of any classification. Note that FEV1 testing is required for participants known or suspected asthma and participants must be excluded if FEV1 <50% of predicted normal.
- CNS involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain MRI and lumbar cytology are required.
- Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis.
- Any ongoing myelodysplastic syndrome or B cell malignancy (other than multiple myeloma).
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- Any history of malignancy, other than multiple myeloma, which is considered at high risk of recurrence requiring systemic therapy.
- Active malignancies (ie, progressing or requiring treatment change in the last 24 months) other than multiple myeloma. The only allowed exceptions are malignancies treated within the last 24 months that are considered cured:
- Non-muscle invasive bladder cancer (solitary Ta-PUNLMP or low grade, <3 cm, no CIS).
- Non-melanoma skin cancers treated with curative therapy or localized melanoma treated with curative surgical resection alone
- Noninvasive cervical cancer
- Localized prostate cancer (M0, N0) with a Gleason Score ≤7a, treated locally only (radical prostatectomy/radiation therapy/focal treatment)
- Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer (antihormonal therapy is permitted)
- Other malignancy that is considered cured with minimal risk of recurrence in consultation with the Sponsor
- Stroke, transient ischemic attack, or seizure within 6 months prior to signing ICF.
- 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 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 ECG abnormalities
- History of severe non-ischemic cardiomyopathy
- Concurrent medical or psychiatric condition or disease that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study, such as:
- Acute diffuse infiltrative pulmonary disease
- Evidence of active systemic viral, fungal, or bacterial infection, requiring systemic antimicrobial therapy
- History of autoimmune disease with the exception of vitiligo, type I diabetes, and prior autoimmune thyroid disease that is currently euthyroid based on clinical symptoms and laboratory testing.
- Disabling psychiatric conditions (eg, alcohol or drug abuse), severe dementia, or altered mental status.
- Any other issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site, to understand informed consent or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
- History of noncompliance with recommended medical treatments
- Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug (daratumumab, lenalidomide, teclistamab or talquetamab) or its excipients (refer to the appropriate IBs and SmPCs) or analogues and study-required co-medication.
- Incidence of gastrointestinal disease that may significantly alter the absorption of oral drugs.
- Received a strong CYP3A4 inducer within 5 half-lives prior to the first dose of study treatment (Flockhart 2021).
- Plasmapheresis within 28 days prior to the first dose of study treatment.
- Participant had major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment.
- NOTE: Participants with planned surgical procedures to be conducted under local anesthesia may participate. Kyphoplasty or vertebroplasty are not considered major surgery. If there is a question whether a procedure is considered a major surgery, the investigator must consult with the appropriate Sponsor representative and resolve any issues before enrolling a participant in the study.
- Taken any disallowed therapies as noted in Section 6.8, Concomitant Therapy before the planned first dose of study treatment.
- Received a live, attenuated vaccine within 4 weeks before the first dose of study drug. Non-live or replicating vaccines approved or authorized for emergency use (eg, COVID-19) by local health authorities are allowed.
- HIV infection (positive, history, treatment for HIV).
- Hepatitis B infection (ie, HbsAg or HBV-DNA positive). In the event the infection status is unclear, quantitative viral levels are necessary to determine the infection status.
- Active hepatitis C infection as measured by positive HCV-RNA testing. Participants with a history of HCV antibody positivity must undergo HCV-RNA testing. 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase 3 Randomized Study of Teclistamab and Talquetamab (Tec-Tal) Versus Daratumumab and Lenalidomide (DR) in Minimal Residual Disease (MRD) Positive Patients With Newly Diagnosed Multiple Myeloma After Autologous Hematopoietic Stem Cell Transplantation (TiTan)
Multiple myeloma is a type of blood cancer that can come back even after effective treatment. After high-dose therapy and autologous stem cell transplantation (ASCT), some patients have no visible signs of disease, but small numbers of cancer cells may still remain in the body. This is called measurable residual disease (MRD). These remaining cells may lead to disease relapse.
The purpose of this study is to find out whether a new maintenance treatment can eliminate these remaining cancer cells more effectively than the current standard treatment. More effective maintenance therapy may help reduce the risk of disease progression and improve long-term outcomes for patients.
Read more
This study, called TiTan, is a phase III, multicenter clinical trial conducted in Poland. It will include 248 adult patients with newly diagnosed multiple myeloma who have undergone ASCT, have no signs of disease progression, but still have detectable MRD.
Participants will be randomly assigned (by chance) to one of two treatment groups. Neither the patient nor the doctor can choose the group.
In the experimental group, patients will receive two immunotherapy medicines, teclistamab and talquetamab. If MRD becomes undetectable after the protocol-defined period, treatment may be stopped and the patient will continue under observation.
In the standard treatment group, patients will receive daratumumab and lenalidomide, which are commonly used maintenance treatments. The duration and adjustments of treatment may depend on MRD results.
The main goal of the study is to determine how many patients achieve undetectable MRD after 12 months of treatment together with a complete response to therapy. This will show whether the new treatment is more effective in removing residual cancer cells.
The study will also evaluate how long patients live without disease progression, overall survival, treatment safety, and the impact of treatment on patients' daily functioning and quality of life. In addition, researchers will assess whether achieving undetectable MRD leads to better long-term outcomes.
Patient safety will be closely monitored throughout the study. Participants will undergo regular medical check-ups, including blood tests, bone marrow tests, and imaging studies. All side effects will be carefully recorded and assessed according to international standards. Patients may withdraw from the study at any time without giving a reason.
This non-commercial study aims to improve knowledge about maintenance treatment in multiple myeloma after ASCT and may help support future treatment decisions for patients with this disease.
Read the detailed description
Multiple myeloma is a malignant plasma cell disorder characterized by repeated relapses despite advances in treatment. Following induction therapy and high-dose chemotherapy with autologous stem cell transplantation (ASCT), many patients achieve deep clinical responses. However, a proportion of patients remain positive for measurable residual disease (MRD), indicating the presence of residual malignant plasma cells and an increased risk of disease progression.
The TiTan study (protocol PMC011) is a phase III, randomized, open-label, multicenter clinical trial conducted in Poland. The study evaluates the efficacy and safety of two maintenance treatment strategies in adult patients with newly diagnosed multiple myeloma who remain MRD-positive after ASCT.
The study is designed to evaluate whether maintenance therapy with teclistamab in combination with talquetamab can improve treatment outcomes compared with standard maintenance therapy with daratumumab and lenalidomide in participants with newly diagnosed multiple myeloma who remain MRD-positive after ASCT.
This is a randomized, open-label, parallel-group study enrolling approximately 248 adult participants. Eligible participants have newly diagnosed multiple myeloma, have completed high-dose chemotherapy and ASCT, and have confirmed MRD positivity assessed using sensitive laboratory methods.
Participants may receive up to two cycles of consolidation therapy after ASCT. Eligible participants are randomized within a defined period after transplantation to one of two treatment arms in a 1:1 ratio.
Participants assigned to the experimental arm receive maintenance therapy with teclistamab and talquetamab. Participants assigned to the control arm receive maintenance therapy with daratumumab and lenalidomide. Treatment administration and duration follow protocol-defined procedures.
Treatment response is assessed according to International Myeloma Working Group (IMWG) criteria. MRD is evaluated in bone marrow samples using next-generation flow cytometry (NGF) at a sensitivity level of 10-⁵.
Disease assessments include evaluation of monoclonal protein using standard laboratory methods, including serum and urine protein electrophoresis, immunofixation, serum free light chain assessment, and imaging studies when clinically indicated.
Participants are followed throughout the study for evaluation of disease status, response to treatment, safety, and survival outcomes. Following completion of study treatment, participants continue protocol-defined follow-up assessments. After disease progression, information on subsequent anti-myeloma therapies and long-term outcomes is collected until study completion.
Safety and tolerability are assessed throughout the study using adverse event reporting, clinical examinations, and laboratory evaluations. Adverse events are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Persistence of MRD after ASCT is associated with an increased risk of disease progression in multiple myeloma. This study evaluates whether an immunotherapy-based maintenance strategy can achieve deeper disease control than standard maintenance treatment in patients with residual disease after transplantation and further explores the relationship between MRD status and clinical outcomes.
- Conditions
- Multiple Myeloma (MM)
- Being tested
- Teclistamab, Talquetamab, Daratumumab (Subcutaneously), Lenalidomide
- Keywords
- Multiple Myeloma, Maintanance Therapy, Measurable residual disease, Autologous stem cell transplantation, Bispecific antibodies, Bone marrow disease assessment
- Medical subject headings
- Multiple Myeloma, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeclistamabDrug
Teclistamab is administered as part of combination immunotherapy according to protocol-defined dosing and schedule in participants receiving maintenance treatment for multiple myeloma.
TalquetamabDrug
Talquetamab is administered in combination with teclistamab as part of maintenance immunotherapy according to protocol-defined dosing and schedule.
Daratumumab (Subcutaneously)Drug
Daratumumab is administered as part of standard maintenance therapy according to protocol-defined dosing and schedule in participants with multiple myeloma.
LenalidomideDrug
Lenalidomide is administered as continuous maintenance therapy according to protocol-defined dosing and schedule in combination with daratumumab.
| Study group | Role | What they receive |
|---|---|---|
| Arm A (Tec-Tal) | Experimental | Participants receive maintenance therapy with teclistamab in combination with talquetamab. The study evaluates whether maintenance treatment with dual immunotherapy can improve eradication of measurable residual disease in participants with newly diagnosed multiple myeloma who remain MRD-positive after autologous stem cell transplantation. Treatment is administered according to protocol-defined procedures, and participants are followed for assessment of efficacy and safety outcomes. Receives: Drug: Teclistamab; Drug: Talquetamab |
| Arm B (Dara-R) | Active comparator | Participants receive maintenance therapy with daratumumab and lenalidomide. This treatment regimen represents the comparator maintenance strategy for participants with newly diagnosed multiple myeloma who remain MRD-positive after autologous stem cell transplantation. Treatment is administered according to protocol-defined procedures, and participants are followed for assessment of efficacy and safety outcomes. Receives: Drug: Daratumumab (Subcutaneously); Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Achieving MRD Negativity With Complete Response
The proportion of participants achieving measurable residual disease negativity at a sensitivity level of 10^-5 together with complete response, assessed according to International Myeloma Working Group (IMWG) criteria at the specified timepoint.
Measured: At Month 12
Secondary outcomes (10)
Progression-Free Survival
Time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first.
Measured: Through study completion, up to approximately 36 months after enrollment of the last participant
Change From Baseline in Global Health Status and Functional Scales Assessed by EORTC QLQ-C30
Mean change from baseline in global health status and functional scales assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Measured: From baseline through study completion (up to approximately 36 months after enrollment of the last participant)
Change From Baseline in Multiple Myeloma-Specific Quality of Life Assessed by EORTC QLQ-MY20
Mean change from baseline in multiple myeloma-specific quality of life assessed using the European Organisation for Research and Treatment of Cancer Multiple Myeloma Module (EORTC QLQ-MY20).
Measured: From baseline through study completion (up to approximately 36 months after enrollment of the last participant)
Overall Survival
Time from randomization to death from any cause.
Measured: Through study completion, up to approximately 36 months after enrollment of the last participant
Proportion of Participants Achieving Complete Response or Better
The proportion of participants achieving complete response or better, assessed according to International Myeloma Working Group (IMWG) criteria.
Measured: Through study completion, up to approximately 36 months after enrollment of the last participant
Progression-Free Survival in Subsequent Therapy (PFS2)
Time from randomization to progression following the next line of therapy or death from any cause.
Measured: Through study completion, up to approximately 36 months after enrollment of the last participant
Proportion of Participants Achieving MRD Negativity
The proportion of participants achieving measurable residual disease negativity at a sensitivity level of 10^-5.
Measured: Through study completion, up to approximately 36 months after enrollment of the last participant
Duration of MRD Negativity
Time from first documented measurable residual disease negativity to loss of MRD negativity or disease progression.
Measured: Through study completion, up to approximately 36 months after enrollment of the last participant
Incidence of Adverse Events
Number of participants experiencing adverse events, including severity and relationship to study treatment, assessed according to CTCAE criteria.
Measured: From first dose up to study completion (approximately 36 months after enrollment of the last participant)
Incidence of Serious Adverse Events
Number of participants experiencing serious adverse events.
Measured: From first dose up to study completion (approximately 36 months after enrollment of the last participant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionJun 2031 (estimated)
- Study completionApr 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma (MM)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Polish Myeloma Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Agency, Poland, Johnson & Johnson
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740486
- Sponsor's protocol ID
- PMC011
- Other IDs
- 2024/ABM/02/00004, 64407564MMY3011, 2025-525097-11-00, 2025
- Acronym
- TiTan
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Randomized Study of Teclistamab and Talquetamab (Tec-Tal) Versus Daratumumab and Lenalidomide (DR) in Minimal Residual Disease (MRD) Positive Patients With Newly Diagnosed Multiple Myeloma After Autologous Hematopoietic Stem Cell Transplantation (TiTan)
- ClinicalTrials.gov ID
- NCT07740486
- Acronym / sponsor ID
- TiTan / PMC011
- Conditions
- Multiple Myeloma (MM)
- Keywords
- Multiple Myeloma, Maintanance Therapy, Measurable residual disease, Autologous stem cell transplantation, Bispecific antibodies, Bone marrow disease assessment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Polish Myeloma ConsortiumUniversity, hospital or other
- Collaborators
- Medical Research Agency, Poland, Johnson & Johnson
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jun 2031 (estimated)
- Study completion
- Apr 2033 (estimated)
- First posted
- 31 Jul 2026 (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.
Multiple myeloma is a type of blood cancer that can come back even after effective treatment. After high-dose therapy and autologous stem cell transplantation (ASCT), some patients have no visible signs of disease, but small numbers of cancer cells may still remain in the body. This is called measurable residual disease (MRD). These remaining cells may lead to disease relapse.
The purpose of this study is to find out whether a new maintenance treatment can eliminate these remaining cancer cells more effectively than the current standard treatment. More effective maintenance therapy may help reduce the risk of disease progression and improve long-term outcomes for patients.
This study, called TiTan, is a phase III, multicenter clinical trial conducted in Poland. It will include 248 adult patients with newly diagnosed multiple myeloma who have undergone ASCT, have no signs of disease progression, but still have detectable MRD.
Participants will be randomly assigned (by chance) to one of two treatment groups. Neither the patient nor the doctor can choose the group.
In the experimental group, patients will receive two immunotherapy medicines, teclistamab and talquetamab. If MRD becomes undetectable after the protocol-defined period, treatment may be stopped and the patient will continue under observation.
In the standard treatment group, patients will receive daratumumab and lenalidomide, which are commonly used maintenance treatments. The duration and adjustments of treatment may depend on MRD results.
The main goal of the study is to determine how many patients achieve undetectable MRD after 12 months of treatment together with a complete response to therapy. This will show whether the new treatment is more effective in removing residual cancer cells.
The study will also evaluate how long patients live without disease progression, overall survival, treatment safety, and the impact of treatment on patients' daily functioning and quality of life. In addition, researchers will assess whether achieving undetectable MRD leads to better long-term outcomes.
Patient safety will be closely monitored throughout the study. Participants will undergo regular medical check-ups, including blood tests, bone marrow tests, and imaging studies. All side effects will be carefully recorded and assessed according to international standards. Patients may withdraw from the study at any time without giving a reason.
This non-commercial study aims to improve knowledge about maintenance treatment in multiple myeloma after ASCT and may help support future treatment decisions for patients with this disease.
Detailed description
Multiple myeloma is a malignant plasma cell disorder characterized by repeated relapses despite advances in treatment. Following induction therapy and high-dose chemotherapy with autologous stem cell transplantation (ASCT), many patients achieve deep clinical responses. However, a proportion of patients remain positive for measurable residual disease (MRD), indicating the presence of residual malignant plasma cells and an increased risk of disease progression.
The TiTan study (protocol PMC011) is a phase III, randomized, open-label, multicenter clinical trial conducted in Poland. The study evaluates the efficacy and safety of two maintenance treatment strategies in adult patients with newly diagnosed multiple myeloma who remain MRD-positive after ASCT.
The study is designed to evaluate whether maintenance therapy with teclistamab in combination with talquetamab can improve treatment outcomes compared with standard maintenance therapy with daratumumab and lenalidomide in participants with newly diagnosed multiple myeloma who remain MRD-positive after ASCT.
This is a randomized, open-label, parallel-group study enrolling approximately 248 adult participants. Eligible participants have newly diagnosed multiple myeloma, have completed high-dose chemotherapy and ASCT, and have confirmed MRD positivity assessed using sensitive laboratory methods.
Participants may receive up to two cycles of consolidation therapy after ASCT. Eligible participants are randomized within a defined period after transplantation to one of two treatment arms in a 1:1 ratio.
Participants assigned to the experimental arm receive maintenance therapy with teclistamab and talquetamab. Participants assigned to the control arm receive maintenance therapy with daratumumab and lenalidomide. Treatment administration and duration follow protocol-defined procedures.
Treatment response is assessed according to International Myeloma Working Group (IMWG) criteria. MRD is evaluated in bone marrow samples using next-generation flow cytometry (NGF) at a sensitivity level of 10-⁵.
Disease assessments include evaluation of monoclonal protein using standard laboratory methods, including serum and urine protein electrophoresis, immunofixation, serum free light chain assessment, and imaging studies when clinically indicated.
Participants are followed throughout the study for evaluation of disease status, response to treatment, safety, and survival outcomes. Following completion of study treatment, participants continue protocol-defined follow-up assessments. After disease progression, information on subsequent anti-myeloma therapies and long-term outcomes is collected until study completion.
Safety and tolerability are assessed throughout the study using adverse event reporting, clinical examinations, and laboratory evaluations. Adverse events are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Persistence of MRD after ASCT is associated with an increased risk of disease progression in multiple myeloma. This study evaluates whether an immunotherapy-based maintenance strategy can achieve deeper disease control than standard maintenance treatment in patients with residual disease after transplantation and further explores the relationship between MRD status and clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (Tec-Tal) | Experimental | Drug: Teclistamab, Drug: TalquetamabParticipants receive maintenance therapy with teclistamab in combination with talquetamab. The study evaluates whether maintenance treatment with dual immunotherapy can improve eradication of measurable residual disease in participants with newly diagnosed multiple myeloma who remain MRD-positive after autologous stem cell transplantation. Treatment is administered according to protocol-defined procedures, and participants are followed for assessment of efficacy and safety outcomes. |
| Arm B (Dara-R) | Active comparator | Drug: Daratumumab (Subcutaneously), Drug: LenalidomideParticipants receive maintenance therapy with daratumumab and lenalidomide. This treatment regimen represents the comparator maintenance strategy for participants with newly diagnosed multiple myeloma who remain MRD-positive after autologous stem cell transplantation. Treatment is administered according to protocol-defined procedures, and participants are followed for assessment of efficacy and safety outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Documented diagnosis of MM as per IMWG diagnostic criteria.
- Newly diagnosed patients who have completed a single or tandem autologous stem cell transplant after receiving quadruplet induction (containing an anti-CD38 antibody, an immunomodulatory drug, and a proteasome inhibitor). Up to 2 cycles of post-ASCT consolidation are acceptable.
- Patients must have received high-dose chemotherapy and a first ASCT within 12 months from the initiation of induction therapy.
- Patients must be within 6 months of their most recent ASCT, or within 7 months for patients who received consolidation therapy.
- Positive minimal residual disease (at a 10-⁵ threshold) in the bone marrow assessed by NGF after autologous stem cell transplantation (assessed 60 to 150 days after transplantation and after completion of any consolidation therapy, with the assessment used for eligibility performed prior randomization).
Key exclusion criteria (39 listed)
- Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the NCI CTCAE Version 5.0.
- COPD with a 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.
- Severe persistent asthma within the past 2 years (see Appendix x[DS2.1] [for severity of Asthma]), uncontrolled asthma of any classification. Note that FEV1 testing is required for participants known or suspected asthma and participants must be excluded if FEV1 <50% of predicted normal.
- CNS involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain MRI and lumbar cytology are required.
- Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis.
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 is administered as part of combination immunotherapy according to protocol-defined dosing and schedule in participants receiving maintenance treatment for multiple myeloma. | Drug | Arm A (Tec-Tal) |
| TalquetamabTalquetamab is administered in combination with teclistamab as part of maintenance immunotherapy according to protocol-defined dosing and schedule. | Drug | Arm A (Tec-Tal) |
| Daratumumab (Subcutaneously)Daratumumab is administered as part of standard maintenance therapy according to protocol-defined dosing and schedule in participants with multiple myeloma. | Drug | Arm B (Dara-R) |
| LenalidomideLenalidomide is administered as continuous maintenance therapy according to protocol-defined dosing and schedule in combination with daratumumab. | Drug | Arm B (Dara-R) |
Primary outcome
Proportion of Participants Achieving MRD Negativity With Complete Response
Time frame: At Month 12
The proportion of participants achieving measurable residual disease negativity at a sensitivity level of 10^-5 together with complete response, assessed according to International Myeloma Working Group (IMWG) criteria at the specified timepoint.
10 secondary outcomes
Progression-Free Survival
Time frame: Through study completion, up to approximately 36 months after enrollment of the last participant
Change From Baseline in Global Health Status and Functional Scales Assessed by EORTC QLQ-C30
Time frame: From baseline through study completion (up to approximately 36 months after enrollment of the last participant)
Change From Baseline in Multiple Myeloma-Specific Quality of Life Assessed by EORTC QLQ-MY20
Time frame: From baseline through study completion (up to approximately 36 months after enrollment of the last participant)
Overall Survival
Time frame: Through study completion, up to approximately 36 months after enrollment of the last participant
Proportion of Participants Achieving Complete Response or Better
Time frame: Through study completion, up to approximately 36 months after enrollment of the last participant
Progression-Free Survival in Subsequent Therapy (PFS2)
Time frame: Through study completion, up to approximately 36 months after enrollment of the last participant
Proportion of Participants Achieving MRD Negativity
Time frame: Through study completion, up to approximately 36 months after enrollment of the last participant
Duration of MRD Negativity
Time frame: Through study completion, up to approximately 36 months after enrollment of the last participant
Incidence of Adverse Events
Time frame: From first dose up to study completion (approximately 36 months after enrollment of the last participant)
Incidence of Serious Adverse Events
Time frame: From first dose up to study completion (approximately 36 months after enrollment of the last participant)
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 31 Jul 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Teclistamab, Talquetamab and Daratumumab (Subcutaneously) in people with Multiple Myeloma (MM), run by Polish Myeloma Consortium.
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 15 inclusion and 39 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: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Dominik Dytfeld, Professor (+48 61 854 95 71, dytfeld@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Achieving MRD Negativity With Complete Response (time frame: At Month 12). 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 31 Jul 2026.