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Multiple MyelomaPhase 2HD10/DSMMXXNCT05695508

GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5

A Phase 2 study testing Teclistamab (Tec), Daratumumab and Dexamethasone in people with Multiple Myeloma, run by University of Heidelberg Medical Center at 11 sites in Germany.

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

A Phase 2 Study to Evaluate Safety and Efficacy of Teclistamab-, Talquetamab-, and JNJ-79635322-based Combination Regimens in Participants with Newly Diagnosed Transplant Eligible Multiple Myeloma OBJECTIVES: To evaluate the safety and tolerability of teclistamab-, talquetamab-, and JNJ-79635322-based combination… 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?
Teclistamab (Tec), Daratumumab and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
11 sitesGermany
Study dates
1 Dec 2022to 15 Sep 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years of age to 70 years of age, inclusive
  • Have an ECOG performance status score of 0 to 2 at screening
  • Have an ECOG performance status score of 0 to 2 at screening and immediately prior to the start of administration of study treatment
  • Participants in Arms A, A1, B, D, E, E1, F, F1 and G must also satisfy all of the following criteria to be enrolled in the study:
  • 1. Documented multiple myeloma requiring treatment as defined by the criteria below:
  • Multiple myeloma diagnosis according to the IMWG diagnostic criteria
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  • Measurable disease at screening as defined by any of the following:
  • 1. Serum M-protein level ≥1.0 g/dL or 2. Urine M-protein level ≥200 mg/24 hours or 3. Serum immunoglobulin free light chain level ≥10 mg/dL and abnormal serum free light chain ratio 2. Newly diagnosed participants for whom HDT and ASCT is part of the intended treatment plan (except Arm D and G participants).
  • Participants Arm C and C2 must also satisfy all of the following criteria:
  • Newly diagnosed multiple myeloma according to IMWG criteria.
  • Must have received 4 to 6 28-day cycles of 3 or 4 drug-induction therapy that includes a proteasome inhibitor and/or an IMiD with or without anti-CD38 monoclonal antibody and a single or tandem ASCT. Post-ASCT consolidation is permitted for up to 2 cycles as long as the total number of induction plus consolidation cycles does not exceed 6.
  • 3 Must have received only one line of therapy and achieved at least a PR as per IMWG 2016 response criteria based on the investigator's assessment. Participants with plasmacytomas at the time of diagnosis must meet IMWG 2016 response criteria for ≥PR based on repeat imaging utilizing the same modality 4. Must have received HDT and ASCT within 12 months of the start of induction therapy and be within 6 months of the last ASCT (7 months for participants who received consolidation) at the time of enrollment.

Who cannot join

  • CNS involvement or clinical signs of meningeal involvement of multiple myeloma.
  • Stroke or seizure within 6 months prior study start Cycle1 Day1.
  • History of transplantations requiring immunosuppressive therapy.
  • Seropositive for HIV, HEP B, Active Hep C infection (details see protocol).
  • COPD with a FEV1 <50% of predicted normal.
  • Moderate /severe persistent asthma within the past 2 years or any uncontrolled asthma. Exclude if FEV1 <50% of predicted normal.
Show all 20Show fewer
  • Concurrent medical or psychiatric condition or disease that is likely to interfere with study procedures, or that in the investigators opinion would constitute a hazard for participants.
  • Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug/excipients.
  • Pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of any study treatment regimen.
  • Plans to father a child while enrolled in this study or within 100 days after the last dose of any component of the study treatment regimen.
  • Arm A, A1, B, D, E, E1, F, F1
  • Prior or current systemic therapy or stem cell transplant 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.
  • Arm B only: Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by the NCI-CTCAE Version 5.
  • Due to a potential interaction with bortezomib, received a strong CYP3A4 inducer within 5 half-lives prior to enrollment
  • Arm C and C2
  • Discontinued treatment due to any AE related to lenalidomide as determined by the investigator.
  • Progressed on multiple myeloma therapy at any time prior to screening.
  • Received a cumulative dose of corticosteroids equivalent to ≥40 mg of dexamethasone within the 14 day period before the start of study treatment administration.
  • Intolerant to the starting dose of lenalidomide (10 mg).
  • For further details on inclusion/exclusion criteria please refer to the study protocol.

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Marc S Raab, Prof. Dr. med contact

+49 6221 56 ext. 8198

s.gmmg@med.uni-heidelberg.de

11 sites in 1 country

Germany11 sites, 11 recruiting

  • Charité University Medicin Berlin

    Berlin, 12203

    Recruiting

  • Clinic Chemnitz gGmbH

    Chemnitz, 09113

    Recruiting

  • University Clinic Technical University Dresden

    Dresden, 01307

    Recruiting

  • University Clinic Düsseldorf

    Düsseldorf, 40225

    Recruiting

  • University Clinic Freiburg

    Freiburg im Breisgau, 79106

    Recruiting

  • Hamburg University Clinic Eppendorf

    Hamburg, 20246

    Recruiting

  • Asklepios Clinic Hamburg Altona

    Hamburg, 22763

    Recruiting

  • University Hospital Heidelberg

    Heidelberg, 69120

    Marc S Raab

    Recruiting

  • University Clinic Schleswig-Holstein Campus Kiel

    Kiel, 24105

    Recruiting

  • Technical University Munich

    Munich, 81675

    Recruiting

  • University Würzburg

    Würzburg

    Recruiting

Other trials in Germany

About this study

Official title: A Phase 2 Study to Evaluate Safety and Efficacy of Teclistamab-, Talquetamab-, and JNJ-79635322-based Combination Regimens in Participants With Newly Diagnosed Transplant Eligible Multiple Myeloma

A Phase 2 Study to Evaluate Safety and Efficacy of Teclistamab-, Talquetamab-, and JNJ-79635322-based Combination Regimens in Participants with Newly Diagnosed Transplant Eligible Multiple Myeloma

OBJECTIVES:

To evaluate the safety and tolerability of teclistamab-, talquetamab-, and JNJ-79635322-based combination regimens over the entire treatment phase for each arm, in participants with ND-TEMM

To evaluate the efficacy of teclistamab- and talquetamab-based combination regimens as induction and post-transplant maintenance treatments; JNJ-79635322-based combinations as induction and as replacement for HDT+ASCT following induction; and teclistamab in combination with talquetamab

Read the detailed description

OVERALL DESIGN:

160 participants will be enrolled with 10 participants in Arm A, 20 participants in Arm A1, 20 participants in Arm B, 10 participants in Arms C and 10 in C2, 20 participants in Arm D, 10 participants in each Arm E, E1 and optionally F and F, and 20 participants in Arm G. Cohorts may be further expanded.

Arms A, A1, B, D, E, E1, F, F1 will receive Induction therapy of 6 cycles (28-days each):

Treatment: Tec-DRd (Arm A, A1), Tec-DVRd (Arm B), Tal-DRd (Arms E, E1), Tal-DVRd (Arms F, F1) followed by HDT and a single ASCT according to local SoC treatment. Thereafter a Maintenance Therapy of maximum 18 cycles with either Tec-D (Arms A, A1, B, E, F) or Tal-D (E1, F1) is performed.

Arm D will receive 6 28-days cycles Tec-DVRd induction followed by 18 cycles Tec-Tal. Arm G will receive 6 28-day cycles of JNJ-79635322-DRd induction, followed by JNJ-79635322-D. No HDT ASCT will be performed in Arm D and Arm G.

In Arm C and C2 participants will enter the study for maintenance treatment of 18 cycles with Tec-D (Arm C) or Tal-DR (Arm C2) , after induction, HDT and ASCT according to local SoC (outside of the study).

Participants will receive maintenance treatment or following induction treatment (Arm D and G) for a maximum of 18 cycles or until confirmed progressive disease, death, intolerable toxicity, loss to follow-up, or consent withdrawal, whichever comes first. An optional end of treatment is possible for patients who have 12 months sustained MRD negativity.

Periodic safety evaluations will be conducted to ensure that treatment is safe and tolerable. Upon treatment discontinuation, an EOT Visit will be conducted. Thereafter, the participant will continue in the Follow-up Phase until death, withdrawal of consent, loss to follow-up, or end of the study, whichever occurs first.

Being tested
Teclistamab (Tec), Daratumumab, Dexamethasone, Lenalidomide, Bortezomib
Medical subject headings
Multiple Myeloma

What participants receive

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

  • Teclistamab (Tec)Drug

    Also called JNJ-64007957

    Subcutaneous administration of Teclistamab

  • DaratumumabDrug

    Subcutaneous administration of Daratumumab

  • DexamethasoneDrug

    administered i.v. or orally

  • LenalidomideDrug

    Administration oral

  • BortezomibDrug

    Subcutaneous administration

  • TalquetamabDrug

    Subcutaneous administration of Daratumumab

  • JNJ-79635322Drug

    Subcutaneous administration

Study groups in NCT05695508
Study groupRoleWhat they receive
Arm A Tec-DRd Induction and Tec-D MaintenanceExperimentalArm A participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
Receives: Drug: Teclistamab (Tec); Drug: Daratumumab; Drug: Dexamethasone; Drug: Lenalidomide
Arm B Tec-DVRd Induction and Tec-D MaintenanceExperimentalArm B participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide, dexamethasone and bortezomib in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
Receives: Drug: Teclistamab (Tec); Drug: Daratumumab; Drug: Dexamethasone; Drug: Lenalidomide; Drug: Bortezomib
Arm C Tec-D MaintenanceExperimentalArm C participants will receive maximum 18 cycles of teclistamab SC injection in combination with daratumumab SC and lenalidomide as maintenance therapy.
Receives: Drug: Teclistamab (Tec); Drug: Daratumumab
Arm A1 Tec-DRd Induction and Tec-D MaintenanceExperimentalArm A1 participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
Receives: Drug: Teclistamab (Tec); Drug: Daratumumab; Drug: Dexamethasone; Drug: Lenalidomide
Arm C2 Tal-DR MaintenanceExperimentalArm C2 participants will receive maximum 18 cycles of talquetamab SC injection in combination with daratumumab SC and lenalidomide as maintenance therapy.
Receives: Drug: Daratumumab; Drug: Lenalidomide; Drug: Talquetamab
Arm D Tec-DRd Induction and Tec-Tal following inductionExperimentalArm D participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by a combination of teclistamab and talquetamab SC injection in maximum 18 cycles of following induction therapy.
Receives: Drug: Teclistamab (Tec); Drug: Daratumumab; Drug: Dexamethasone; Drug: Lenalidomide; Drug: Talquetamab
Arm E Tal-DRd Induction and Tec-D MaintenanceExperimentalArm E participants will receive talquetamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
Receives: Drug: Teclistamab (Tec); Drug: Daratumumab; Drug: Dexamethasone; Drug: Lenalidomide; Drug: Talquetamab
Arm E1 Tal-DRd Induction and Tal-D MaintenanceExperimentalArm E1 participants will receive talquetamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by talquetamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
Receives: Drug: Daratumumab; Drug: Dexamethasone; Drug: Lenalidomide; Drug: Talquetamab
Arm F Tal-DVRd Induction and Tec-D MaintenanceExperimentalArm F participants will receive talquetamab as subcutaneous (SC) injection in combination with daratumumab SC, bortezomib, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
Receives: Drug: Teclistamab (Tec); Drug: Daratumumab; Drug: Dexamethasone; Drug: Lenalidomide; Drug: Bortezomib; Drug: Talquetamab
Arm F1 Tal-DVRd Induction and Tal-D MaintenanceExperimentalArm F1 participants will receive talquetamab as subcutaneous (SC) injection in combination with daratumumab SC, bortezomib, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by talquetamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
Receives: Drug: Daratumumab; Drug: Dexamethasone; Drug: Lenalidomide; Drug: Bortezomib; Drug: Talquetamab
Arm-G JNJ-79635322-DRd induction - JNJ-79635322-D following indExperimentalArm G participants will receive six 28-day cycles of JNJ-79635322-DRd induction, followed byJNJ-79635322-D treatment for a maximum of eighteen 28-day cycles or until confirmed PD, death, intolerable toxicity, loss to follow-up, or consent withdrawal, whichever comes first. Tec-Tal or JNJ-79635322-D treatment can be discontinued when 12 months of sustained MRD negativity has been observed during the study.
Receives: Drug: Daratumumab; Drug: Dexamethasone; Drug: Lenalidomide; Drug: JNJ-79635322

What is being measured

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

  1. number of incidence and severity of adverse events [safety and tolerability]

    Measured: through study completion, up to 28 months

Secondary outcomes (7)

  1. MRD negativity rate

    MRD negativity rate measured by Flow Cytometry

    Measured: after 6 cycles (each cycle is 28 days) induction therapy (app.month 6), after High Dose Therapy (app. month 10), after 18 cycles (each cycle is 28 days) of maintenance therapy (app. month 28)

  2. Response on therapy [efficacy]

    Response on therapy according to IMWG:

    • Overall Response Rate (ORR) (at least a PR or better)
    • Complete Response (CR) or better
    • Very Good Partial Response (VGPR) or better
    • Duration of Response (DoR)

    Measured: after each cycle (each cycle is 28 days) induction ( app. at month 1,2,...,6), after High Dose therapy (app. month 10), after each cycle (each cycle is 28 days) of maintenance (app. at month 11,12, ...28), during FU every 3 months (app. up to 3-4 years)

  3. Progression Free Survival [efficacy]

    Measured: From randomization to the date of disease progression to death (app. up to 3-4 years)

  4. Serum concentration of teclistamab, talquetamab and daratumumab [pharmacokinetics]

    Measured: through study completion, up to 28 months

  5. Presence of ADAs to teclistamab, talquetamab and daratumumab [immunogenicity]

    Measured: through study completion, up to 28 months

  6. Stem cell yield

    feasibility of successful transplantation

    Measured: after High Dose Therapy (after app. 10 months)

  7. days to engraftment

    feasibility of successful transplantation

    Measured: after High Dose Therapy (after app. 10 months)

Timeline

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

  1. First posted25 Jan 2023
  2. Study start1 Dec 2022
  3. Primary completion15 Sep 2028 (estimated)
  4. Study completion15 Sep 2029 (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
Non-randomised
Intervention model
Parallel groups
Model description
Induction phase contains 6 cycles of Tec-DRd \[Arm A, A1, D\] , Tec-DVRd \[Arm B\], Tal-DRd \[Arm E, E1\] or Tal-DVRd \[Arm F, F1\] or JNJ-79635322-DRd \[Arm G\] . Enrollment will be staggered with Arm A opening first. Induction therapy (except Arms D and G) is followed by HDT and a single ASCT according to local SoC. Participants will receive maintenance treatment with Tec-D \[Arm A, A1, B, E. F\] or Tal-D \[E1, F1\] or JNJ-79635322-D \[Arm G\]. Arm C, C1 and C2 participants will enter the study at Maintenance Treatment with Tec-D or Tal-DR after induction, HDT, and ASCT according to local SoC (outside of the study). All Arms receive maintenance treatment for a max. of 18 cycles or until confirmed PD, death, intolerable toxicity, loss to follow-up, or consent withdrawal, whichever comes first. An optional EoT is possible for those patients who have sustained MRD negativity of 12 months. Periodic safety evaluations will be conducted to ensure that treatment is safe and tolerable.
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05695508
Sponsor's protocol ID
GMMG-HD10/DSMM-XX
Acronym
HD10/DSMMXX
Status last verified
Dec 2025
First submitted
30 Nov 2022
Last updated
24 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Raab MS, Weinhold N, Kortum KM, Kronke J, Fenk R, Weisel K, Podola L, Bertsch U, Brobeil A, Mersi J, Huhn S, Arlinghaus R, Hundemer M, Bohl SR, Mai EK, Schub N, Waldschmidt J, Bassermann F, Muller-Tidow C, Heuck C, Sakabedoyan C, Khan J, Ershova E, Koster BD, Engelhardt M, Hanel M, Salwender H, Teipel R, Goldschmidt H, Einsele H, Rasche L; GMMG-HD10/DSMM-XX (MajesTEC-5) investigators. Teclistamab-based induction treatment in transplant-eligible, newly diagnosed multiple myeloma: a phase 2 trial. Nat Med. 2026 Jul;32(7):2440-2448. doi: 10.1038/s41591-026-04471-x. Epub 2026 Jun 25.

    PubMed 42350642

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Teclistamab (Tec), Daratumumab and Dexamethasone in people with Multiple Myeloma, run by University of Heidelberg Medical Center at 11 sites in Germany.

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 12 inclusion and 20 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 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Germany. 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 Marc S Raab, Prof. Dr. med (+49 6221 56 ext. 8198, s.gmmg@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

number of incidence and severity of adverse events [safety and tolerability] (time frame: through study completion, up to 28 months). 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 NCT05695508, which also lists 1 linked publication.

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 24 Dec 2025.

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