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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Bispecific T-cell Redirectors as Part of First Line Treatment in Transplant Eligible Multiple Myeloma Patients

A Phase II Study Measuring MRD Negativity After Bispecific T-cell Redirectors Talquetamab and Teclistamab Consolidation in Sequence as Part of First Line Treatment in Transplant Eligible Multiple Myeloma Patients

Bispecific T-cell Redirectors as Part of First Line Treatment in Transplant Eligible Multiple Myeloma Patients (NCT06505369) is a Phase 2 interventional studying Multiple Myeloma, sponsored by North Estonia Medical Centre. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is Phase 2, open-label, multicentre, non-randomised study evaluating participants with newly diagnosed MM eligible for high-dose therapy. The goal of the study is to determine if consolidation with T-cell redirectors - Talquetamab and Teclistamab in sequence will improve the response depth: increase MRD negative CR rate.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Multiple Myeloma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 50 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Multiple Myeloma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Participant must have documented MM satisfying the IMWG criteria. 2. Newly diagnosed patients eligible for high dose therapy and ASCT. 3. ECOG performance status score ≤2. 4. HIV-positive participants are eligible if they meet all of the following 1. No detectable viral load (ie, \<50 copies/mL) at screening 2. CD4+ count \>300 cells/mm3 at screening 3. No AIDS-defining opportunistic infection within 6 months of screening 4. Receiving HAART. Any changes in HAART due to resistance/progression should occur at least 3 months prior to screening. A change in HAART due to toxicity is allowed up to 4 weeks prior to screening. 5. Must sign an ICF indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study. 6. Willing and able to adhere to the lifestyle restrictions specified in this protocol. 7. A female participant of childbearing potential must have a negative highly sensitive serum (β hCG) pregnancy test at screening 8. A female participant must be 1. Not of childbearing potential or 2. Of childbearing potential and practicing true abstinence; or have a sole partner who is vasectomized; or practicing 2 effective methods of contraception 9. A female participant must agree not to donate eggs or freeze for future use during the study and for 6 months after receiving the last dose of study treatment. 10. A male participant must wear a condom when engaging any sexual activity that allows for passage of ejaculate to another person during the study and for a minimum of 100 days after receiving the last dose of study treatment. 11. A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 100 days after receiving the last dose of study treatment. 12. Have clinical laboratory values meeting the following criteria 1. blood count (hemoglobin) at least 8 g/dL ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Participant must have documented MM satisfying the IMWG criteria. 2. Newly diagnosed patients eligible for high dose therapy and ASCT. 3. ECOG performance status score ≤2. 4. HIV-positive participants are eligible if they meet all of the following 1. No detectable viral load (ie, \<50 copies/mL) at screening 2. CD4+ count \>300 cells/mm3 at screening 3. No AIDS-defining opportunistic infection within 6 months of screening 4. Receiving HAART. Any changes in HAART due to resistance/progression should occur at least 3 months prior to screening. A change in HAART due to toxicity is allowed up to 4 weeks prior to screening. 5. Must sign an ICF indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study. 6. Willing and able to adhere to the lifestyle restrictions specified in this protocol. 7. A female participant of childbearing potential must have a negative highly sensitive serum (β hCG) pregnancy test at screening 8. A female participant must be 1. Not of childbearing potential or 2. Of childbearing potential and practicing true abstinence; or have a sole partner who is vasectomized; or practicing 2 effective methods of contraception 9. A female participant must agree not to donate eggs or freeze for future use during the study and for 6 months after receiving the last dose of study treatment. 10. A male participant must wear a condom when engaging any sexual activity that allows for passage of ejaculate to another person during the study and for a minimum of 100 days after receiving the last dose of study treatment. 11. A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 100 days after receiving the last dose of study treatment. 12. Have clinical laboratory values meeting the following criteria 1. Hemoglobin ≥8 g/dL 2. Platelets ≥75×109/L 3. ANC ≥1.0×109/L 4. AST and ALT ≤2.5×ULN 5. eGFR ≥30 mL/min 6. Total bilirubin \<1.5×ULN Exclusion Criteria: 1. Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloid light chain amyloidosis. 2. Known active CNS involvement or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole brain MRI and lumbar cytology are required. 3. Peripheral neuropathy or neuropathic pain Grade 2 or higher 4. Excluded for any of the following: 1. Any ongoing myelodysplastic syndrome or B cell malignancy (other than MM). 2. Any history of malignancy, other than MM, which is considered at high risk of recurrence requiring systemic therapy. 3. Any active malignancy (ie, progressing or requiring treatment change in the last 24 months) other than MM. The only allowed exceptions are malignancies treated within the last 24 months that are considered cured: 1. Non-muscle invasive bladder cancer (solitary Ta-PUN-LMP or low grade, \<3 cm, no CIS). 2. Non-melanoma skin cancers treated with curative therapy or localized melanoma treated with curative surgical resection alone. 3. Non-invasive cervical cancer. 4. Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ or history of localized breast cancer (anti-hormonal therapy is permitted). 5. Localized prostate cancer (M0, N0) with a Gleason Score ≤7a, treated locally only (RP/RT/focal treatment). 6. Other malignancy that is considered cured with minimal risk of recurrence in consultation with the sponsor's medical monitor. 5. Stroke within 6 months prior to signing ICF. 6. Presence of the following cardiac conditions: 1. New York Heart Association stage III or IV congestive heart failure (see Appendix ) 2. Myocardial infarction or coronary artery bypass graft ≤6 months prior to enrollment, or an unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina) 3. Uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities 4. History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration 5. History of severe non-ischemic cardiomyopathy 7. 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: 1. Uncontrolled diabetes 2. Evidence of active systemic viral, fungal, or bacterial infection, requiring systemic antimicrobial therapy 3. 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 4. Gastrointestinal disease that may significantly alter the absorption of oral drugs 5. Disabling psychiatric conditions (eg, alcohol or drug abuse), severe dementia, or altered mental status 8. 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 9. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients 10. Any of the following: 1. Hepatitis B infection (ie, HBsAg or HBV-DNA positive). 2. Active hepatitis C infection as measured by positive HCV-RNA testing. 11. Prior or current systemic therapy or stem cell transplantation for any plasma cell dyscrasia, with the exception of emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment. 12. Major surgery 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. 13. Contraindications to the use of Dara-VRd per SmPC. 14. Prior or concurrent exposure to any of the following, in the specified time frame prior to first dose of study treatment: 1. Investigational vaccine other than SARS-CoV-2 vaccine approved/in use under emergency approval within 4 weeks. Non-live or non-replicating vaccines authorized for emergency use (eg, COVID-19) by local health authorities are allowed. 2. Live, attenuated vaccine within 4 weeks 3. Monoclonal antibody therapy within 21 days (not used for the treatment of MM) 4. Received a strong CYP3A4 inducer within 5 half-lives prior to start of administration of study treatment 15. Participant is pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment. 16. Participant plans to father a child while enrolled in this study or within 100 days after the last dose of study treatment.

Treatments Being Tested

DRUG

Daratumumab

Daratumumab will be administered by SC injection

DRUG

Bortezomib

Bortezomib will be administered by SC injection

DRUG

Lenalidomide

Lenalidomide will be administered by oral route

DRUG

Dexamethasone

Dexamethasone will be administered by oral route

DRUG

Talquetamab

Talquetamab will be administered by SC injection

DRUG

Teclistamab

Teclistamab will be administered by SC injection

Locations (7)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Copenhagen University Hospital (Rigshospitalet)
Copenhagen, Denmark
Odense University Hospital
Odense, Denmark
Vejle hospital
Vejle, Denmark
North Estonia Medical Centre
Tallinn, Estonia
Oslo University Hospital, Oslo Myeloma Centre
Oslo, Norway
Stavanger University Hospital
Stavanger, Norway
St. Olavs Hospital
Trondheim, Norway

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06505369), the sponsor (North Estonia Medical Centre), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06505369 clinical trial studying?

This is Phase 2, open-label, multicentre, non-randomised study evaluating participants with newly diagnosed MM eligible for high-dose therapy. The goal of the study is to determine if consolidation with T-cell redirectors - Talquetamab and Teclistamab in sequence will improve the response depth: increase MRD negative CR rate. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06505369?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06505369?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06505369. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06505369. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.