NCT04557098Active, not recruitingPhase 2
A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
TECLIMMY1001-P3: A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Teclistamab, a Humanized BCMA x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma
Source: ClinicalTrials.gov · Last updated 31 Jul 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate the efficacy of teclistamab at the recommended Phase 2 dose (RP2D).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 194 (actual)
- First submitted
- 17 Sept 2020
- Start date
- 17 Sept 2020
- Primary completion date
- 9 Nov 2021
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Multiple myeloma
- NCT number
- NCT04557098
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 194
- From 17 Sept 2020 to the primary completion date, 9 Nov 2021
- 51 sites in 11 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received any therapy that is targeted to BCMA, with the exception of Cohort C in Part 3
- Prior antitumor therapy, within 21 days (PI or radiotherapy within 14 days, IMiDs within 7 days, Gene modified adoptive cell therapy within 3 months) prior to first dose of study drug
- Toxicities from previous anticancer therapies that have not resolved to baseline or to \<= grade 1 (except for alopecia or peripheral neuropathy)
- Received a cumulative dose of corticosteroids equivalent to \>=140 mg of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication)
- Myelodysplastic syndrome or active malignancies other than relapsed/refractory multiple myeloma with exceptions are: 1) Non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured 2) Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured. 3) Noninvasive cervical cancer treated within the last 24 months that is considered completely cured. 4) Localized prostate cancer (N0M0) 5) Breast cancer: Adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence. 6) Malignancy that is considered cured with minimal risk of recurrence
- Prior allogenic stem cell transplant \<=6 months
- Prior autologous stem cell transplant \<=12 weeks
- Live, attenuated vaccine within 4 weeks prior to the first dose of teclistamab
Other illness
- Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloid light-chain amyloidosis
- The following medical conditions: Pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency virus (HIV) infection, hepatitis B or C infection, stroke or seizure less than or equal to (\<=) 6 m, autoimmune disease, uncontrolled systemic infection, cardiac conditions (Myocardial Infarction \<= 6 m, stage III-IV congestive heart failure, etc)
Other
- Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma (MM)
Who the study is looking for
- Documented diagnosis of multiple myeloma according to IMWG diagnostic criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Measurable disease: Cohort A and Cohort C: Multiple myeloma must be measurable by central laboratory assessment
- A female participant of childbearing potential must have a negative pregnancy test at screening
- Willing and able to adhere to the prohibitions and restrictions specified in this protocol
- Cohort A: received at least \>=3 prior lines of therapy and previously received a PI, an IMiD and an anti-CD38 monoclonal antibody; Cohort C: received \>= 3 prior lines of therapy that included a PI, an IMiD, an anti-CD38 monoclonal antibody, and an anti-B cell maturation antigen (BCMA) treatment (with CART-T cells or an antibody drug conjugate (ADC)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (51)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Ziekenhuis Gent (Uz Gent) Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| Universitaire Ziekenhuizen Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| Arthur J.E. Child Comprehensive Cancer Centre Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Cross Cancer Institute Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| University Health Network UHN Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| West China Hospital Si Chuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| First Affiliated Hospital of Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Shanghai Changzheng Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shengjing Hospital Of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Tianjin Medical University Cancer Institute and Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| The Second Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Universitaetsklinikum Heidelberg Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| Universitaetsklinikum Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
| Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II, Coordinator of this site? Confirm its status | Tübingen | Germany | Unknown status |
| Universitätsklinikum Würzburg Coordinator of this site? Confirm its status | Würzburg | Germany | Unknown status |
| Hosp. Univ. Germans Trias I Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| Hosp Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hosp. Univ. 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Clinica Univ. de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| Hosp. Quiron Madrid Pozuelo Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Unknown status |
| Hosp Clinico Univ de Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Unknown status |
| Hosp. Univ. Marques de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Unknown status |
| Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Centre Hospitalier Lyon Sud Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| C.H.U. Hotel Dieu - France Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| CHU Poitiers - Hôpital la Milétrie Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
| Pôle IUC Oncopole CHU Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| CHRU - Hôpital Bretonneau Coordinator of this site? Confirm its status | Tours | France | Unknown status |
| University College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| University Hospital Southampton Coordinator of this site? Confirm its status | Sothampton | United Kingdom | Unknown status |
| Royal Marsden Hospital Coordinator of this site? Confirm its status | Sutton | United Kingdom | Unknown status |
| Azienda Ospedaliera Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Unknown status |
| Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| VU Medisch Centrum Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Sahlgrenska University Hospital Coordinator of this site? Confirm its status | Gothenburg | Sweden | Unknown status |
| Skåne University Hospital Coordinator of this site? Confirm its status | Lund | Sweden | Unknown status |
| Haematology Centre, R 51 Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
| Winship Cancer Institute, Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Levine Cancer Institute Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Barbara Ann Karmanos Cancer Institute Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| City of Hope Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Stanford University Medical Center Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
Related publications
- Efficacy and Safety of Teclistamab in Relapsed/Refractory Multiple Myeloma: 2-Year Follow-Up From MajesTEC-1 China Cohort.EJHaem · 2026 · PMID 42534634
- Longitudinal mechanisms of response, resistance and relapse to teclistamab in multiple myeloma: results from MajesTEC-1.Haematologica · 2026 · PMID 42273947
- Revised Recommendations for Restarting Teclistamab Following Dose Delays: Insights from the MajesTEC-1 Study on Clinical Safety, and from Simulated Pharmacokinetics and Cytokine Dynamics.Target Oncol · 2026 · PMID 41886220
- Plain language summary of the management of certain side effects of teclistamab in people with multiple myeloma.Future Oncol · 2026 · PMID 41574880
- Efficacy and safety of teclistamab in triple-class exposed relapsed/refractory multiple myeloma: Pooled findings from three clinical cohorts and a retrospective cohort.Cancer · 2026 · PMID 41485109
This page is information, not medical advice. Discuss any trial with your doctor.