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Multiple MyelomaPhase 2TALTECNCT06505369

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

A Phase 2 study testing Daratumumab, Bortezomib and Lenalidomide in people with Multiple Myeloma, run by North Estonia Medical Centre at 7 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Multiple Myeloma
What is being tested?
Daratumumab, Bortezomib and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
7 sitesin 3 countries
Study dates
19 Jun 2024to Oct 2028
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant must have documented MM satisfying the IMWG criteria.
  • Newly diagnosed patients eligible for high dose therapy and ASCT.
  • ECOG performance status score ≤2.
  • HIV-positive participants are eligible if they meet all of the following
  • No detectable viral load (ie, <50 copies/mL) at screening
  • CD4+ count >300 cells/mm3 at screening
Show all 24Show fewer
  • No AIDS-defining opportunistic infection within 6 months of screening
  • 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.
  • 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.
  • Willing and able to adhere to the lifestyle restrictions specified in this protocol.
  • A female participant of childbearing potential must have a negative highly sensitive serum (β hCG) pregnancy test at screening
  • A female participant must be
  • Not of childbearing potential or
  • Of childbearing potential and practicing true abstinence; or have a sole partner who is vasectomized; or practicing 2 effective methods of contraception
  • 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.
  • 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.
  • 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.
  • Have clinical laboratory values meeting the following criteria
  • Hemoglobin ≥8 g/dL
  • Platelets ≥75×109/L
  • ANC ≥1.0×109/L
  • AST and ALT ≤2.5×ULN
  • eGFR ≥30 mL/min
  • Total bilirubin <1.5×ULN

Who cannot join

  • Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloid light chain amyloidosis.
  • 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.
  • Peripheral neuropathy or neuropathic pain Grade 2 or higher
  • Excluded for any of the following:
  • Any ongoing myelodysplastic syndrome or B cell malignancy (other than MM).
  • Any history of malignancy, other than MM, which is considered at high risk of recurrence requiring systemic therapy.
Show all 41Show fewer
  • 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:
  • Non-muscle invasive bladder cancer (solitary Ta-PUN-LMP or low grade, <3 cm, no CIS).
  • Non-melanoma skin cancers treated with curative therapy or localized melanoma treated with curative surgical resection alone.
  • Non-invasive cervical cancer.
  • Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ or history of localized breast cancer (anti-hormonal therapy is permitted).
  • Localized prostate cancer (M0, N0) with a Gleason Score ≤7a, treated locally only (RP/RT/focal treatment).
  • Other malignancy that is considered cured with minimal risk of recurrence in consultation with the sponsor's medical monitor.
  • Stroke within 6 months prior to signing ICF.
  • Presence of the following cardiac conditions:
  • New York Heart Association stage III or IV congestive heart failure (see Appendix )
  • 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)
  • Uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities
  • History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration
  • 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:
  • Uncontrolled diabetes
  • 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 thyroiditis that is currently euthyroid based on clinical symptoms and laboratory testing
  • Gastrointestinal disease that may significantly alter the absorption of oral drugs
  • 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
  • Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients
  • Any of the following:
  • Hepatitis B infection (ie, HBsAg or HBV-DNA positive).
  • Active hepatitis C infection as measured by positive HCV-RNA testing.
  • 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.
  • 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.
  • Contraindications to the use of Dara-VRd per SmPC.
  • Prior or concurrent exposure to any of the following, in the specified time frame prior to first dose of study treatment:
  • 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.
  • Live, attenuated vaccine within 4 weeks
  • Monoclonal antibody therapy within 21 days (not used for the treatment of MM)
  • Received a strong CYP3A4 inducer within 5 half-lives prior to start of administration of study treatment
  • 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.
  • Participant plans to father a child while enrolled in this study or within 100 days after the last dose of study treatment.

Trial locations and contacts

7 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Diana Loigom, MD contact

+372 6172173

diana.loigom@regionaalhaigla.ee

7 sites in 3 countries

Denmark3 sites, 3 recruiting

  • Copenhagen University Hospital (Rigshospitalet)

    Copenhagen, 2100

    Agoston Gyula Szabo, MD; PhD, +45-35-45-37-36, agoston.gyula.szabo@regionh.dk

    Not yet recruiting

  • Odense University Hospital

    Odense, 5000

    Thomas Lund, MD; PhD, +45 2145 0256, Thomas.Lund2@rsyd.dk

    Not yet recruiting

  • Vejle hospital

    Vejle, 7100

    Sarah Leeth Hansen Farmer, MD; PhD, +45 7940 5957, Sarah.Farmer1@rsyd.dk

    Not yet recruiting

Other trials in Denmark

Norway3 sites, 3 recruiting

  • Oslo University Hospital, Oslo Myeloma Centre

    Oslo, 0450

    Jakob Nordberg Nørgaard, MD, (+47) 23 07 04 60, jaknoe@ous-hf.no

    Not yet recruiting

  • Stavanger University Hospital

    Stavanger, 4068

    Einar Haukås, MD; PhD

    +47 51518383, einar.haukas@sus.no

    Not yet recruiting

  • St. Olavs Hospital

    Trondheim, 7030

    Tobias Schmidt Slørdahl, MD; PhD

    (+47) 911 45 009, tobias.s.slordahl@ntnu.no

    Not yet recruiting

Other trials in Norway

Estonia1 site, 1 recruiting

  • North Estonia Medical Centre

    Tallinn, 13419

    Diana Loigom, MD, +372 617 2173, diana.loigom@regionaalhaigla.ee

    Recruiting

Other trials in Estonia

About this study

Official title: 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

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.

Read the detailed description

A total of 50 transplant-eligible patients with newly diagnosed multiple myeloma in need of treatment will be enrolled.

The study consists of three phases: Induction, Consolidation, and Follow-up. Induction will consist of Dara-VRd and consolidation Part I will include talquetamab and Part II will include teclistamab.

Follow-up Phase After consolidation, treatment continues upon physician's choice: the options are ASCT with maintenance or only maintenance with lenalidomide.

Efficacy will be evaluated by serum/urine electrophoresis monthly; by serum/urine immunofixation, bone marrow morphology and flow cytometry when CR/sCR is suspected;

MRD will be evaluated by NGS ( at the level of 10-6) and FDG PET-CT ( by Deauville score) at various timepoints during induction, consolidation and follow-up.

Participants quality of life, symptoms, functional and general well-being will be captured using 3 PRO measures ( PRO-CTCAE, EORTC QLQ-C30, FACT-Cog).

The safety of study drugs will be assessed by physical examinations, vital signs, ECGs, clinical laboratory tests, neurologic examinations (including ICE scores), ECOG performance status, and AE monitoring according to NCI-CTCAE Version 5.0), grading of CRS and ICANS will be assessed based on ASTCT guidelines.

Being tested
Daratumumab, Bortezomib, Lenalidomide, Dexamethasone, Talquetamab
Keywords
Multiple Myeloma, Transplant Eligible, Talquetamab, Teclistamab, MRD negativity
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DaratumumabDrug

    Also called JNJ-54767414

    Daratumumab will be administered by SC injection

  • BortezomibDrug

    Also called EU Substance number SUB20020

    Bortezomib will be administered by SC injection

  • LenalidomideDrug

    Also called EU Substance number SUB25389

    Lenalidomide will be administered by oral route

  • DexamethasoneDrug

    Also called EU Substance number SUB07017MIG

    Dexamethasone will be administered by oral route

  • TalquetamabDrug

    Also called JNJ-64407564

    Talquetamab will be administered by SC injection

  • TeclistamabDrug

    Also called JNJ-64007957

    Teclistamab will be administered by SC injection

Study groups in NCT06505369
Study groupRoleWhat they receive
Induction with Dara -VRd + Consolidation with Talquetamab and Teclistamab as monotherapy in sequenceExperimentalInduction with Daratumumab-VRd; Consolidation part I with Talquetamab; Consolidation part II with Teclistamab.
Receives: Drug: Daratumumab; Drug: Bortezomib; Drug: Lenalidomide; Drug: Dexamethasone; Drug: Talquetamab; Drug: Teclistamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate efficacy in terms of Minimal Residual Disease (MRD) negative Complete Remission rate by next generation sequencing ( NGS) after completing consolidation with talquetamab and teclistamab.

    MRD measured by NGS with a sensitivity level of 10-6.

    Measured: 18 months approximately

  2. Evaluate efficacy in terms of Minimal Residual Disease (MRD) negative Complete Remission rate by Fluorodeoxyglucose Positron Emission Tomography-Computerized Tomography (FDG PET-CT) scan after completing consolidation with talquetamab and teclistamab.

    MRD assessed by FDG PET-CT scan using Deauville score.

    Measured: 18 months approximately

Secondary outcomes (16)

  1. Evaluate efficacy in terms of Minimal Residual Disease (MRD) negative Complete Remission rate by next generation sequencing ( NGS) after completing induction treatment with Daratumumab-VRd

    MRD measured by NGS with a sensitivity level of 10-6.

    Measured: 6 months approximately

  2. Evaluate efficacy in terms of Minimal Residual Disease (MRD) negative Complete Remission rate by Fluorodeoxyglucose Positron Emission Tomography-Computerized Tomography (FDG PET-CT) scan after completing induction treatment with Daratumumab-VRd.

    MRD assessed by FDG PET-CT scan using Deauville score.

    Measured: 6 months approximately

  3. Evaluate efficacy in terms of Minimal Residual Disease (MRD) negative Complete Remission conversion by next generation sequencing ( NGS) after completing consolidation treatment with talquetamab.

    MRD measured by NGS with a sensitivity level of 10-6.

    Measured: 12 months approximately

  4. Evaluate efficacy in terms of Minimal Residual Disease (MRD) negative Complete Remission conversion by Fluorodeoxyglucose Positron Emission Tomography-Computerized Tomography (FDG PET-CT) scan after completing consolidation treatment with talquetamab.

    MRD assessed by FDG PET-CT scan using Deauville score.

    Measured: 12 months approximately

  5. Evaluate efficacy in terms of Minimal Residual Disease (MRD) negative Complete Remission conversion by next generation sequencing ( NGS) after completing consolidation treatment with teclistamab.

    MRD measured by NGS with a sensitivity level of 10-6.

    Measured: 18 months approximately

  6. Evaluate efficacy in terms of Minimal Residual Disease (MRD) negative Complete Remission conversion by Fluorodeoxyglucose Positron Emission Tomography-Computerized Tomography (FDG PET-CT) scan after completing consolidation treatment with teclistamab.

    MRD assessed by FDG PET-CT scan using Deauville score.

    Measured: 18 months approximately

  7. Evaluate efficacy in terms of Sustained Minimal Residual Disease (MRD) negative Complete Remission rate by next generation sequencing ( NGS).

    MRD measured by NGS with a sensitivity level of 10-6.

    Measured: 42 months approximately

  8. Evaluate efficacy in terms of Sustained Minimal Residual Disease (MRD) negative Complete Remission rate by Fluorodeoxyglucose Positron Emission Tomography-Computerized Tomography (FDG PET-CT) scan.

    MRD assessed by FDG PET-CT scan using Deauville score.

    Measured: 42 months approximately

  9. To assess Overall Response Rate (ORR)

    ORR is defined as proportion of patients achieveing documentation of a response (Partial Response or better) from the first dose of study drug on treatment. Response to treatment is defined according to the International Myeloma Working Group (IMWG) criteria.

    Measured: 42 months approximately

  10. To assess Overall Survival (OS).

    OS is defined as the time from the date of first dose of study drug to the date of the subject's death. If the subject is alive or the vital status is unknown, then the subject's data will be censored at the date the subject was last known to be alive. OS is measured in months.

    Measured: 42 months approximately

  11. To assess Progression free Survival (PFS).

    PFS is defined as the time from the date of first dose of study drug to the date of first documented disease progression, as defined in the International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurs first. For subjects who have not progressed and are alive, data will be censored at the last disease evaluation before the start of any subsequent anti-myeloma therapy. PFS is measured in months.

    Measured: 42 months approximately

  12. To assess Duration of Response ( DoR).

    DoR is the date of initial documentation of a response (Partial Response or better) to the date of first documented evidence of progressive disease, as defined in the International Myeloma Working Group (IMWG) criteria. Relapse from complete response is not considered as disease progression. For subjects who have not progressed, data will be censored at the last disease evaluation before the start of any subsequent anti-myeloma therapy. DoR is measured in months.

    Measured: 42 months approximately

  13. To assess Time to Next anti-myeloma Treatment (TNT).

    TNT is defined as the time between date of first dose of study drug and the first dose of the next treatment received. TNT is measured in months.

    Measured: 42 months approximately

  14. To assess the safety and tolerability of the treatment described in the protocol.

    Incidence of treatment-emergent adverse events. AE monitoring according to NCI-CTCAE Version 5.0), grading of CRS and ICANS will be assessed based on ASTCT guidelines.

    Measured: 42 months approximately

  15. To assess quality of life on the treatment described in the protocol.

    Quality of life in general is assessed using PRO questionnaire, such as EORTC QLQ-C30.

    Measured: 42 months approximately

  16. To assess incidence of participant -recorded side effects on the treatment described in the protocol.

    Participant - recorded side effects are assessed using PRO questionnaire, such as PRO-CTCAE.

    Measured: 42 months approximately

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2024
  2. Study start19 Jun 2024
  3. Primary completionNov 2026 (estimated)
  4. Study completionOct 2028 (estimated)

Resources

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
Sequential
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06505369
Sponsor's protocol ID
CT number 2023-508212-38-00
Acronym
TALTEC
Status last verified
Jul 2024
First submitted
18 Jun 2024
Last updated
17 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Daratumumab, Bortezomib and Lenalidomide in people with Multiple Myeloma, run by North Estonia Medical Centre at 7 sites in 3 countries.

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 24 inclusion and 41 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 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Denmark, Norway, Estonia. 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 Diana Loigom, MD (+372 6172173, diana.loigom@regionaalhaigla.ee), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate efficacy in terms of Minimal Residual Disease (MRD) negative Complete Remission rate by next generation sequencing ( NGS) after completing consolidation with talquetamab and teclistamab. (time frame: 18 months approximately). The study lists 2 primary outcomes in all. 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 NCT06505369.

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 17 Jul 2024.

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