Multiple MyelomaPhase 3AugMMentNCT07671287
GMMG-HD11/DSMM XXI/64007957MMY3010
A Phase 3 study testing Teclistamab, Daratumumab and Lenalidomide in people with Multiple Myeloma, run by University of Heidelberg Medical Center.
Trial summary
This is an open-label, randomized interventional multicenter Phase 3 clinical trial to investigate the efficacy and safety of Tec-DRd induction therapy and fixed-duration Tec-D maintenance post ASCT in adult participants with TE NDMM, compared with the SoC PERSEUS regimen. 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, Daratumumab and Lenalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 399 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2026to 30 Jan 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 70 years of age, inclusive.
- Documented MM as defined by the criteria below:
- MM diagnosis according to IMWG diagnostic criteria (Appendix 3),
- Untreated MM requiring systemic therapy,
- Measurable disease at screening, as defined by any of the following:
- Serum M-protein level ≥1.0 g/dL (central laboratory); or ii. Urine M-protein level ≥200 mg/24 hours (central laboratory); or iii. Serum immunoglobulin free light chain ≥10 mg/dL (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio.
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- Have an ECOG performance status 0-2 (Appendix 5) at screening and immediately prior to the start of administration of study treatment.
- Have clinical laboratory values meeting the following criteria during the screening period. Refer to Section 5.4.3 for criteria prior to first dose.
- Hemoglobin ≥7.5 g/dL (≥4.65 mmol/L; without prior RBC transfusion ≤7 days before the screening laboratory test; recombinant human erythropoietin use is permitted). Platelets ≥75×109/L in participants in whom <50% of bone marrow nucleated cells are plasma cells and ≥50×109/L in participants in whom ≥50% of bone marrow nucleated cells are plasma cells. Absolute neutrophil count ≥1.0×109/L (prior growth factor support is permitted but must be without support for ≥7 days for G-CSF or GM-CSF and ≥14 days for pegylated-G-CSF) before the screening laboratory test.
- Chemistry:
- AST and ALT ≤3×ULN. Total bilirubin Total bilirubin ≤2.0×ULN; except in participants with congenital bilirubinemia, such as Gilbert syndrome (in which case if total bilirubin is >2.0×ULN, then direct bilirubin ≤1.5×ULN is required).
- eGFR ≥30 mL/min based on Cockcroft-Gault formula or creatine clearance measured by a 24-h urine collection. Serum calcium corrected for albumin ≤14 mg/dL (≤3.5 mmol/L) or free ionized calcium ≤6.5 mg/dL (≤1.6 mmol/L; see Appendix 10).
- Eligible for HD melphalan and ASCT (in the opinion of the investigator).
- A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test at screening and again either a serum or urine pregnancy test within 24 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study.
- A female participant must be (as defined in Appendix 1):
- Not of childbearing potential, or
- Of childbearing potential and practicing at least 1 highly effective method of contraception
- A female participant must agree not to donate eggs (ova, oocytes) or freeze for future use, for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study treatment. Female participants should consider preservation of eggs prior to study treatment because anticancer treatments may impair fertility.
- A male participant must wear a condom (with or without spermicidal foam/gel/film/cream/suppository) when engaging in any activity that allows for
- A male participant must agree not to donate sperm for the purpose of reproduction during the study and for 3 months after receiving the last dose of study treatment. Male participants should consider preservation of sperm prior to study treatment as anticancer treatments may impair fertility.
- Must agree to abstain from donating blood while taking lenalidomide and for 28 days following discontinuation of lenalidomide therapy.
- 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.
- Must be willing and able to adhere to the lifestyle restrictions specified in this protocol
Who cannot join
- 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.
- 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:
- Nonmuscle invasive bladder cancer (solitary Ta-PUN-LMP or low grade, <3 cm, no carcinoma in situ).
- Nonmelanoma skin cancers treated with curative therapy or localized melanoma treated with curative surgical resection alone.
- Noninvasive cervical cancer.
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- Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ or history of localized breast cancer (antihormonal therapy is permitted).
- Localized prostate cancer (M0, N0) with a Gleason Score ≤7a, treated locally only (radical prostatectomy/radiation therapy/focal treatment).
- Other malignancy that is considered cured with minimal risk of recurrence in consultation with the sponsor's medical monitor.
- Plasma cell leukemia (presence of ≥5% circulating plasma cells in peripheral blood smears in patients otherwise diagnosed with symptomatic MM; Fernández de Larrea 2021), smoldering MM, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), primary light chain amyloidosis.
- CNS involvement or clinical signs of meningeal involvement of MM. If either is suspected, negative whole brain MRI and lumbar cytology are required to exclude CNS involvement.
- Prior BCMA-directed therapy.
- Prior T-cell redirection therapy.
- History of allogeneic or autologous stem cell transplant or prior organ transplant.
- Prior or concurrent exposure to any of the following within the specified timeframe prior to randomization:
- Targeted therapy, epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or ≥5 half-lives, whichever is less.
- Investigational vaccine within 4 weeks.
- Monoclonal antibody therapy within 21 days.
- Radiotherapy within 14 days or focal radiation within 7 days.
- Received a cumulative dose of corticosteroids equivalent to dexamethasone ≥160 mg within 14 days before treatment randomization (see Appendix 7).
- Received a live, attenuated vaccine within 4 weeks before the first dose of study treatment. Nonlive or nonreplicating vaccines authorized for emergency use (eg, COVID-19) by local health authorities are allowed.
- 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.
- Concurrent medical or psychiatric condition or disease that is likely to interfere with study procedures or results, ie, those listed below, or any others that in the opinion of the investigator would constitute a hazard for participating in the study.
- Acute diffuse infiltrative pulmonary disease.
- Evidence of active systemic viral, fungal, or bacterial infection, requiring systemic antimicrobial therapy.
- Active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before start of study treatment. Exception: Participants with vitiligo, controlled type I diabetes, and prior autoimmune thyroid disease that is currently euthyroid based on clinical symptoms and laboratory testing are eligible regardless of when these conditions were diagnosed.
- 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 study 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.
- Stroke, transient ischemic attack, or seizure within 6 months prior to randomization.
- Any of the following:
- Seropositive for human immunodeficiency virus (HIV).
- Hepatitis B infection (ie, positive HBsAg or detectable HBV DNA levels by RTPCR).
- In the event the infection status is unclear, quantitative viral levels are necessary to determine the infection status see Section 6.8.2.8 for further required assessments.
- Active hepatitis C infection as measured by detectable HCV RNA. 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.
- 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.
- Moderate or severe persistent asthma within the past 2 years (see Appendix 8), or 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.
- Presence of the following cardiac conditions:
- New York Heart Association stage III or IV congestive heart failure (Appendix 12).
- Myocardial infarction, unstable angina, 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.
- 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 3 months after the last dose of study treatment.
- History of hypersensitivity to study intervention or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
- Participation in other clinical studies or observation period of competing clinical studies, respectively.
- Held in an institution by legal or official order.
- Legally incapacitated.
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: Accelerate Improvement in Multiple Myeloma for Newly Diagnosed Transplant-Eligible Patients
This is an open-label, randomized interventional multicenter Phase 3 clinical trial to investigate the efficacy and safety of Tec-DRd induction therapy and fixed-duration Tec-D maintenance post ASCT in adult participants with TE NDMM, compared with the SoC PERSEUS regimen.
A total of 399 participants with TE NDMM aged ≥18 and ≤70 years and an Eastern CooperativeOncology Group (ECOG) status 0-2 will be included.
Read more
The primary objective of the clinical trial:
To determine the efficacy of Tec-DRd compared to DVRd after 6 cycles of induction/consolidation therapy and HD melphalan and ASCT, before start of maintenance therapy in participants with TE NDMM.
Endpoint: Cumulative MRD negativity by NGS at a sensitivity level of 10-6 before start of maintenance therapy.
Read the detailed description
This is an open-label, randomized interventional multicenter Phase 3 clinical trial to investigate the efficacy and safety of Tec-DRd induction therapy and fixed-duration Tec-D maintenance post ASCT in adult participants with TE NDMM, compared with the SoC PERSEUS regimen. The trial will comprise 3 phases: screening, treatment, and follow-up. The treatment phase includes induction therapy (incorporating HDT+ASCT lasting 1-2 months, which is not part of the clinical trial and will be performed as SoC according to local guidelines), followed by maintenance therapy and follow up. A total of 399 participants with TE NDMM aged ≥18 and ≤70 years and an Eastern Cooperative Oncology Group (ECOG) status 0-2 will be included.
Eligible participants will receive one of 3 treatments:
- Arm A (SoC treatment based on the PERSEUS regimen - control): DVRd induction therapy, HD melphalan + ASCT, DVRd consolidation therapy, followed by DR maintenance therapy. After maintenance therapy, the participant will be treated according to SoC.
- Arm B: Tec-DRd induction therapy, HD melphalan + ASCT, followed by DR maintenance therapy. Treatment stopped thereafter.
- Arm C: Tec-DRd induction therapy, HD melphalan + ASCT, followed by Tec-D then DR maintenance therapy. Treatment stopped thereafter. The stratification variables will be age (<65/≥65) and high risk/no-high-risk/unknown based on the International Myeloma Working Group (IMWG) 2025 definition.
- Conditions
- Multiple Myeloma
- Being tested
- Teclistamab, Daratumumab, Lenalidomide, Bortezomib (B), dexamethsone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeclistamabDrug
TEC SC
DaratumumabDrug
subcutaneous
LenalidomideDrug
oral administration
Bortezomib (B)Drug
subcutaneous
dexamethsoneDrug
iv; po
| Study group | Role | What they receive |
|---|---|---|
| Arm A DVRd induction (+ HDT ASCT), DVRd consolidation therapy followed by DR maintenance | Active comparator | SoC treatment based on the PERSEUS regimen - control):
DVRd induction therapy, HD melphalan + ASCT, DVRd consolidation therapy, followed by DR maintenance therapy. After the maintenance therapy, the participant will be treated according to SoC. Receives: Drug: Daratumumab; Drug: Lenalidomide; Drug: Bortezomib (B); Drug: dexamethsone |
| Arm B - Tec-DRd induction ( incl. HDT ASCT) followed by DR maintenance therapy. | Experimental | Tec-DRd induction therapy, HD melphalan + ASCT, followed by DR maintenance therapy. Treatment stopped thereafter. Receives: Drug: Teclistamab; Drug: Daratumumab; Drug: Lenalidomide; Drug: dexamethsone |
| Arm C - Tec-DRd induction (incl. HDT ASCT), followed by Tec-D then DR maintenance therapy | Experimental | Tec-DRd induction therapy, HD melphalan + ASCT, followed by Tec-D then DR maintenance therapy. Treatment stopped thereafter. Receives: Drug: Teclistamab; Drug: Daratumumab; Drug: Lenalidomide; Drug: dexamethsone |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the efficacy (MRD negativity at a level of 10-6) of Tec-DRd compared to DVRd after induction/consolidation therapy and HD melphalan and ASCT, before start of maintenance therapy in participants with TE NDMM
Cumulative MRD negativity by NGS at a sensitivity level of 10-6 before start of maintenance therapy.
Measured: after 6 cycles (each cycle is 28 days) of induction/consolidation therapy and HD melphalan and ASCT (which occurs appr. 1 year after start of treatment), before start of maintenance therapy.
Secondary outcomes (2)
Sustained MRDnegative CR rate composite endpoint of events (death, progression, discontinuation of all treatments, Grade 3 or Grade 4 infections, and pause of more than 62 days of all study treatments).
- Sustained (≥12 months) cumulative MRDnegative CR rate (10-6) by NGS up to 24 months of maintenance therapy.
- Hierarchical composite endpoint of events (within 24 months of maintenance therapy), including death, progression, discontinuation of all treatments, Grade 3 or Grade 4 infections, and pause of more than 62 days of all study treatments.
Measured: 1) up to 24 months of maintenance therapy. 2) within 24 months of maintenance therapy
To determine response rates, MRD at a level of 10-5, best overall response and DOR, PFS, OS, stem cell harvest.
MRD at level 10-5 by NGS PFS DOR Time-to-next treatment (TTnT) OS Stem cell harvest QoL Best and overall response and CR rates before start of maintenance and up to 24 months of maintenance
Measured: up to 24 months of maintenance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start30 Jun 2026 (estimated)
- Primary completion14 Feb 2031 (estimated)
- Study completion30 Jan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies 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
- 399 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Heidelberg Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Raab, University of Heidelberg Medical Center
- Investigators
- Marc S Raab, Prof. Dr. med, Principal investigator, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671287
- Sponsor's protocol ID
- GMMG-HD11/DSMM-XXI
- Other IDs
- 2025-523990-40-00, 2025
- Acronym
- AugMMent
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Avet-Loiseau H, Davies FE, Samur MK, Corre J, D'Agostino M, Kaiser MF, Raab MS, Weinhold N, Gutierrez NC, Paiva B, Neri P, Weisel K, Maura F, Walker BA, Bustoros M, Stewart AK, Usmani SZ, Hillengass J, Chng WJ, Keats JJ, Martinez-Lopez J, Sperling AS, Touzeau C, Zhan F, Raje NS, Cavo M, Bolli N, Ghobrial IM, Dhodapkar MV, Jagannath S, Spencer A, Parekh S, Bahlis NJ, Lonial S, Sonneveld P, Bergsagel L, Orlowski RZ, Morgan G, Mateos MV, Rajkumar SV, San Miguel JF, Anderson KC, Moreau P, Kumar S, Prosper F, Munshi NC. International Myeloma Society/International Myeloma Working Group Consensus Recommendations on the Definition of High-Risk Multiple Myeloma. J Clin Oncol. 2025 Aug 20;43(24):2739-2751. doi: 10.1200/JCO-24-01893. Epub 2025 Jun 9.
PubMed 40489728
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerate Improvement in Multiple Myeloma for Newly Diagnosed Transplant-Eligible Patients
- ClinicalTrials.gov ID
- NCT07671287
- Acronym / sponsor ID
- AugMMent / GMMG-HD11/DSMM-XXI
- Conditions
- Multiple Myeloma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 399 participants (estimated)
- Lead sponsor
- University of Heidelberg Medical CenterUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 14 Feb 2031 (estimated)
- Study completion
- 30 Jan 2033 (estimated)
- First posted
- 26 Jun 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.
This is an open-label, randomized interventional multicenter Phase 3 clinical trial to investigate the efficacy and safety of Tec-DRd induction therapy and fixed-duration Tec-D maintenance post ASCT in adult participants with TE NDMM, compared with the SoC PERSEUS regimen.
A total of 399 participants with TE NDMM aged ≥18 and ≤70 years and an Eastern CooperativeOncology Group (ECOG) status 0-2 will be included.
The primary objective of the clinical trial:
To determine the efficacy of Tec-DRd compared to DVRd after 6 cycles of induction/consolidation therapy and HD melphalan and ASCT, before start of maintenance therapy in participants with TE NDMM.
Endpoint: Cumulative MRD negativity by NGS at a sensitivity level of 10-6 before start of maintenance therapy.
Detailed description
This is an open-label, randomized interventional multicenter Phase 3 clinical trial to investigate the efficacy and safety of Tec-DRd induction therapy and fixed-duration Tec-D maintenance post ASCT in adult participants with TE NDMM, compared with the SoC PERSEUS regimen. The trial will comprise 3 phases: screening, treatment, and follow-up. The treatment phase includes induction therapy (incorporating HDT+ASCT lasting 1-2 months, which is not part of the clinical trial and will be performed as SoC according to local guidelines), followed by maintenance therapy and follow up. A total of 399 participants with TE NDMM aged ≥18 and ≤70 years and an Eastern Cooperative Oncology Group (ECOG) status 0-2 will be included.
Eligible participants will receive one of 3 treatments:
- Arm A (SoC treatment based on the PERSEUS regimen - control): DVRd induction therapy, HD melphalan + ASCT, DVRd consolidation therapy, followed by DR maintenance therapy. After maintenance therapy, the participant will be treated according to SoC.
- Arm B: Tec-DRd induction therapy, HD melphalan + ASCT, followed by DR maintenance therapy. Treatment stopped thereafter.
- Arm C: Tec-DRd induction therapy, HD melphalan + ASCT, followed by Tec-D then DR maintenance therapy. Treatment stopped thereafter. The stratification variables will be age (<65/≥65) and high risk/no-high-risk/unknown based on the International Myeloma Working Group (IMWG) 2025 definition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A DVRd induction (+ HDT ASCT), DVRd consolidation therapy followed by DR maintenance | Active comparator | Drug: Daratumumab, Drug: Lenalidomide, Drug: Bortezomib (B), Drug: dexamethsoneSoC treatment based on the PERSEUS regimen - control): DVRd induction therapy, HD melphalan + ASCT, DVRd consolidation therapy, followed by DR maintenance therapy. After the maintenance therapy, the participant will be treated according to SoC. |
| Arm B - Tec-DRd induction ( incl. HDT ASCT) followed by DR maintenance therapy. | Experimental | Drug: Teclistamab, Drug: Daratumumab, Drug: Lenalidomide, Drug: dexamethsoneTec-DRd induction therapy, HD melphalan + ASCT, followed by DR maintenance therapy. Treatment stopped thereafter. |
| Arm C - Tec-DRd induction (incl. HDT ASCT), followed by Tec-D then DR maintenance therapy | Experimental | Drug: Teclistamab, Drug: Daratumumab, Drug: Lenalidomide, Drug: dexamethsoneTec-DRd induction therapy, HD melphalan + ASCT, followed by Tec-D then DR maintenance therapy. Treatment stopped thereafter. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 18 to 70 years of age, inclusive.
- Documented MM as defined by the criteria below:
- Have an ECOG performance status 0-2 (Appendix 5) at screening and immediately prior to the start of administration of study treatment.
- Have clinical laboratory values meeting the following criteria during the screening period. Refer to Section 5.4.3 for criteria prior to first dose.
- Hemoglobin ≥7.5 g/dL (≥4.65 mmol/L; without prior RBC transfusion ≤7 days before the screening laboratory test; recombinant human erythropoietin use is permitted). Platelets ≥75×109/L in participants in whom <50% of bone marrow nucleated cells are plasma cells and ≥50×109/L in participants in whom ≥50% of bone marrow nucleated cells are plasma cells. Absolute neutrophil count ≥1.0×109/L (prior growth factor support is permitted but must be without support for ≥7 days for G-CSF or GM-CSF and ≥14 days for pegylated-G-CSF) before the screening laboratory test.
Key exclusion criteria (49 listed)
- 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.
- 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:
- Plasma cell leukemia (presence of ≥5% circulating plasma cells in peripheral blood smears in patients otherwise diagnosed with symptomatic MM; Fernández de Larrea 2021), smoldering MM, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), primary light chain amyloidosis.
- CNS involvement or clinical signs of meningeal involvement of MM. If either is suspected, negative whole brain MRI and lumbar cytology are required to exclude CNS involvement.
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 |
|---|---|---|
| TeclistamabTEC SC | Drug | Arm B - Tec-DRd induction ( incl. HDT ASCT) followed by DR maintenance therapy., Arm C - Tec-DRd induction (incl. HDT ASCT), followed by Tec-D then DR maintenance therapy |
| Daratumumabsubcutaneous | Drug | Arm A DVRd induction (+ HDT ASCT), DVRd consolidation therapy followed by DR maintenance, Arm B - Tec-DRd induction ( incl. HDT ASCT) followed by DR maintenance therapy., Arm C - Tec-DRd induction (incl. HDT ASCT), followed by Tec-D then DR maintenance therapy |
| Lenalidomideoral administration | Drug | Arm A DVRd induction (+ HDT ASCT), DVRd consolidation therapy followed by DR maintenance, Arm B - Tec-DRd induction ( incl. HDT ASCT) followed by DR maintenance therapy., Arm C - Tec-DRd induction (incl. HDT ASCT), followed by Tec-D then DR maintenance therapy |
| Bortezomib (B)subcutaneous | Drug | Arm A DVRd induction (+ HDT ASCT), DVRd consolidation therapy followed by DR maintenance |
| dexamethsoneiv; po | Drug | Arm A DVRd induction (+ HDT ASCT), DVRd consolidation therapy followed by DR maintenance, Arm B - Tec-DRd induction ( incl. HDT ASCT) followed by DR maintenance therapy., Arm C - Tec-DRd induction (incl. HDT ASCT), followed by Tec-D then DR maintenance therapy |
Primary outcome
To determine the efficacy (MRD negativity at a level of 10-6) of Tec-DRd compared to DVRd after induction/consolidation therapy and HD melphalan and ASCT, before start of maintenance therapy in participants with TE NDMM
Time frame: after 6 cycles (each cycle is 28 days) of induction/consolidation therapy and HD melphalan and ASCT (which occurs appr. 1 year after start of treatment), before start of maintenance therapy.
Cumulative MRD negativity by NGS at a sensitivity level of 10-6 before start of maintenance therapy.
2 secondary outcomes
Sustained MRDnegative CR rate composite endpoint of events (death, progression, discontinuation of all treatments, Grade 3 or Grade 4 infections, and pause of more than 62 days of all study treatments).
Time frame: 1) up to 24 months of maintenance therapy. 2) within 24 months of maintenance therapy
To determine response rates, MRD at a level of 10-5, best overall response and DOR, PFS, OS, stem cell harvest.
Time frame: up to 24 months of maintenance
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 26 Jun 2026.
- Background: PubMed 40489728Avet-Loiseau H, Davies FE, Samur MK, Corre J, D'Agostino M, Kaiser MF, Raab MS, Weinhold N, Gutierrez NC, Paiva B, Neri P, Weisel K, Maura F, Walker BA, Bustoros M, Stewart AK, Usmani SZ, Hillengass J, Chng WJ, Keats JJ, Martinez-Lopez J, Sperling AS, Touzeau C, Zhan F, Raje NS, Cavo M, Bolli N, Ghobrial IM, Dhodapkar MV, Jagannath S, Spencer A, Parekh S, Bahlis NJ, Lonial S, Sonneveld P, Bergsagel L, Orlowski RZ, Morgan G, Mateos MV, Rajkumar SV, San Miguel JF, Anderson KC, Moreau P, Kumar S, Prosper F, Munshi NC. International Myeloma Society/International Myeloma Working Group Consensus Recommendations on the Definition of High-Risk Multiple Myeloma. J Clin Oncol. 2025 Aug 20;43(24):2739-2751. doi: 10.1200/JCO-24-01893. Epub 2025 Jun 9.
- Related InfoLink provided by the sponsor.
- 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.
Marc S Raab, Prof. Dr. med principal investigator
University Hospital Heidelberg
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Teclistamab, Daratumumab and Lenalidomide in people with Multiple Myeloma, run by University of Heidelberg Medical Center.
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 23 inclusion and 49 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 26 Jun 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 Marc S Raab, Prof. Dr. med (+49 6221-56819, marc.raab@med.uni-.heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the efficacy (MRD negativity at a level of 10-6) of Tec-DRd compared to DVRd after induction/consolidation therapy and HD melphalan and ASCT, before start of maintenance therapy in participants with TE NDMM (time frame: after 6 cycles (each cycle is 28 days) of induction/consolidation therapy and HD melphalan and ASCT (which occurs appr. 1 year after start of treatment), before start of maintenance therapy.). 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 NCT07671287, 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 26 Jun 2026.