Multiple MyelomaPhase 1NCT04108195
A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma
A Phase 1 study testing Daratumumab, Talquetamab and Teclistamab in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 24 sites in 5 countries.
Trial summary
The purpose of this study is to identify recommended Phase 2 doses (RP2Ds) for each treatment combination (between daratumumab plus talquetamab and teclistamab plus daratumumab with or without pomalidomide) and to characterize the safety of each RP2D for selected treatment combinations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Daratumumab, Talquetamab and Teclistamab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 24 sitesin 5 countries
- Study dates
- 21 Feb 2020to 31 Dec 2027
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
- Must have either of the following: a) received at least 3 prior lines of therapy including a proteasome inhibitor (PI) (greater than or equal to [>=] 2 cycles or 2 months of treatment) and an immunomodulatory drug (IMiD) (>=2 cycles or 2 months of treatment) in any order during the treatment or b) disease that is double refractory to a PI and an IMiD
- Measurable disease at screening as defined by any of the following: Serum monoclonal protein (M-protein) level >=1.0 grams per deciliter (g/dL) (in non- immunoglobulin G (IgG) myeloma, an M-protein level >=0.5 g/dL); or Urine M-protein level >=200 milligrams (mg)/24 hours; or Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 at screening and at Cycle 1, Day 1 predose
- Female participants of childbearing potential must have a negative highly-sensitive serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test (less than [<] 5 international units per milliliter [IU/mL]) at screening and a negative urine or serum pregnancy test within 1 day before the first dose of study drug
Who cannot join
- Treatment in the prior 3 months with an anti- cluster of differentiation 38 (CD38) therapy (example, daratumumab), or discontinuation of a prior anti-CD38 therapy at any time due to an adverse event related to the anti-CD38 therapy
- Live, attenuated vaccine within 4 weeks prior to the first dose of study drug unless approved by sponsor
- Active Central nervous system involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
- Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Participants with resolved infection must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded
- Active hepatitis C infection as measured by positive hepatitis C virus- ribonucleotide (HCV)-RNA testing. Participants with a history of Hepatitis C virus antibody positivity must undergo HCV-RNA testing
Trial locations and contacts
24 sites in 5 countries.
24 sites in 5 countries
United States10 sites
Levine Cancer Institute
Charlotte, North Carolina, 28204
City of Hope National Medical Center
Duarte, California, 91010
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, 92618
Medical College Of Wisconsin
Milwaukee, Wisconsin, 53226
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, 37232
The Blavatnik Family Chelsea Medical Center at Mount Sinai
New York, New York, 10011
Mount Sinai Medical Center
New York, New York, 10029
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of California San Francisco
San Francisco, California, 94143
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
Spain6 sites
Hosp Clinic de Barcelona
Barcelona, 08036
Inst. Cat. Doncologia-H Duran I Reynals
Barcelona, 08908
Germans Trias I Pujol
Barcelona, 08916
Hosp Univ Fund Jimenez Diaz
Madrid, 28040
Clinica Univ. de Navarra
Pamplona, 31008
Hosp Clinico Univ de Salamanca
Salamanca, 37007
Germany4 sites
Universitatsklinikum Freiburg
Freiburg im Breisgau, 79106
Universitaetsklinikum Hamburg Eppendorf
Hamburg, 20246
Universitaetsklinikum Heidelberg
Heidelberg, 69120
Universitatsklinikum Wurzburg
Würzburg, 97080
Canada2 sites
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2
University Health Network UHN Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Netherlands2 sites
VU Medisch Centrum
Amsterdam, 1081 HV
LUMC
Leiden, 2333ZA
About this study
Official title: A Phase 1b Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Subjects With Multiple Myeloma
The purpose of this study is to identify recommended Phase 2 doses (RP2Ds) for each treatment combination (between daratumumab plus talquetamab and teclistamab plus daratumumab with or without pomalidomide) and to characterize the safety of each RP2D for selected treatment combinations.
Read the detailed description
Multiple myeloma is a malignant plasma cell disorder characterized by osteolytic lesions, increased susceptibility to infections, hypercalcemia, and renal failure. Overall rationale of study is that daratumumab in combination with talquetamab or teclistamab with or without pomalidomide may lead to enhanced clinical responses in treatment of relapsed or refractory multiple myeloma through multiple mechanisms of action. Daratumumab is human immunoglobulin G1 kappa monoclonal antibody (IgG1k) that binds with high affinity to a unique epitope on cluster of differentiation 38 (CD38) in a variety of hematological malignancies including multiple myeloma. Talquetamab and teclistamab are bispecific T cell redirection antibodies. Talquetamab binds to cluster of differentiation 3 (CD3) receptor complex on T cells and to G protein-coupled receptor family C group 5-member D (GPRC5D), a 7-transmembrane receptor protein on plasma cells and teclistamab binds to human and cynomolgus-CD3 and B cell maturation antigen (BCMA). Purpose of study is to evaluate safety of daratumumab in combination with talquetamab and teclistamab with or without pomalidomide, and to evaluate preliminary antitumor activity of each combination. Study consists of a screening period, treatment period (Part 1: dose escalation and Part 2: dose expansion), a Post-treatment Follow-up Period (after the last dose of study drug and will continue for up to 16 weeks for each subject), and a Long-term Extension Period. The study will end when one of the following occurs: 1) the study drug has received marketing authorization and, if regionally applicable, government reimbursement is available; 2) a long-term extension rollover study has commenced for participants who are still benefiting from study treatment as determined by their investigator; or 3) all participants have discontinued study treatment. Total duration of study is approximately 5 years and 6 months. Efficacy, safety, pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points. Participants safety will be monitored throughout study by Study Evaluation Team (SET). SET consists of members of sponsor's study team and participating investigators.
- Conditions
- Multiple Myeloma
- Being tested
- Daratumumab, Talquetamab, Teclistamab, Pomalidomide
- 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, Darzalex
Participants will receive daratumumab.
TalquetamabDrug
Also called JNJ-64407564
Participants will receive talquetamab.
TeclistamabDrug
Also called JNJ-64007957
Participants will receive teclistamab.
PomalidomideDrug
Participants will receive pomalidomide.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose Escalation | Experimental | Participants will be assigned to either a combination of 1) daratumumab plus teclistamab or 2) daratumumab plus talquetamab or 3) daratumumab plus talquetamab plus pomalidomide or 4) daratumumab plus teclistamab plus pomalidomide. Receives: Drug: Daratumumab; Drug: Talquetamab; Drug: Teclistamab; Drug: Pomalidomide |
| Part 2: Dose Expansion | Experimental | Participants will be treated with the RP2D(s) for selected treatment combinations determined in Part 1. Receives: Drug: Daratumumab; Drug: Talquetamab; Drug: Teclistamab; Drug: Pomalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Participants With Dose Limiting Toxicity (DLT)
The dose limiting toxicities are based on drug related adverse events and defined as any of the following events: hematological or non-hematological toxicity of grade 3 or higher.
Measured: Up to 52 Weeks
Part 1: Number of Participants With Dose Limiting Toxicity by Severity
The dose limiting toxicities are based on drug related adverse events and defined as any of the following events: hematological or non-hematological toxicity of grade 3 or higher.
Measured: Up to 52 Weeks
Part 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product.
Measured: Up to 48 Weeks
Part 2: Number of Participants With Adverse Events and SAEs by Severity
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product.
Measured: Up to 48 Weeks
Secondary outcomes (13)
Serum Concentration of Daratumumab
Serum concentration of daratumumab will be assessed.
Measured: Up to 52 Weeks
Serum Concentration of Talquetamab
Serum concentration of talquetamab will be assessed.
Measured: Up to 52 Weeks
Serum Concentration of Teclistamab
Serum concentration of teclistamab will be assessed.
Measured: Up to 52 Weeks
Biomarker Assessment of Daratumumab
Serum cytokine concentrations will be measured at the time of drug infusion of daratumumab for biomarker assessment.
Measured: Up to Cycle 7 Day 1 (each cycle of 28-days)
Biomarker Assessment of Talquetamab
Serum cytokine concentrations will be measured at the time of drug infusion of talquetamab for biomarker assessment.
Measured: Up to Cycle 7 Day 1 (each cycle of 28-days)
Biomarker Assessment of Teclistamab
Serum cytokine concentrations will be measured at the time of drug infusion of teclistamab for biomarker assessment.
Measured: Up to Cycle 7 Day 1 (each cycle of 28-days)
Number of Participants With Anti-Drug Antibodies to Daratumumab
Number of participants with anti-drug antibodies to daratumumab will be assessed.
Measured: Up to 52 Weeks
Number of Participants With Anti-Drug Antibodies to Talquetamab
Number of participants with anti-drug antibodies to talquetamab will be assessed.
Measured: Up to 52 Weeks
Number of Participants With Anti-Drug Antibodies to Teclistamab
Number of Participants with anti-drug antibodies to teclistamab will be assessed.
Measured: Up to 52 Weeks
Overall Response Rate (ORR)
ORR is defined as the percentage of participants who have a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria.
Measured: Up to 48 Weeks
Clinical Benefit Rate
Clinical benefit rate (ORR + minimal response [MR]) is defined as the of participants who have a MR or better according to the IMWG criteria.
Measured: Up to 48 Weeks
Duration of Response (DOR)
DOR is defined as the time from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria.
Measured: Up to 48 Weeks
Time to Response
Time to response is defined as the time between date of first dose of study drug and the first efficacy evaluation that the participant has met all criteria for PR or better.
Measured: Up to 48 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start21 Feb 2020
- Primary completion7 Apr 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108195
- Sponsor's protocol ID
- CR108620
- Other IDs
- 64407564MMY1002, 2019-000330-19, 2023-503468-17-00, 2023, 2019
- Status last verified
- Nov 2026
- First submitted
- 26 Sep 2019
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Publications
Rodriguez-Otero P, Morillo D, D'Souza A, Reece D, van de Donk N, Chari A, Dholaria B, Kortum KM, Mateos MV, Mckay JT, Rosinol L, Sureda A, Wasch R, Bhutani M, Weisel KC, Bahlis NJ, Vishwamitra D, Skerget S, Bakshi KK, Guo Y, Sun W, Goldberg JD, Stephenson T, Prior TJ, Vandenberk L, Lee S, Smit MD, Verona RI, Oriol A, Krishnan A. Teclistamab and Daratumumab Immune-Based Doublet Therapy for Relapsed/Refractory Multiple Myeloma: the TRIMM-2 Study. Blood Adv. 2026 Sep 2:bloodadvances.2026020648. doi: 10.1182/bloodadvances.2026020648. Online ahead of print.
PubMed 42685673Chari A, van de Donk NWCJ, Dholaria B, Weisel K, Mateos MV, Goldschmidt H, Martin TG, Morillo D, Reece D, Rodriguez-Otero P, Bhutani M, D'Souza A, Oriol A, Rosinol L, Bahlis NJ, Vishwamitra D, Skerget S, Verona RI, Bakshi K, Kang L, Prior TJ, Vandenberk L, Tolbert J, Lee S, Smit MD, Wasch R. Talquetamab plus daratumumab for the treatment of relapsed or refractory multiple myeloma in the TRIMM-2 study. Blood. 2025 Dec 11;146(24):2902-2913. doi: 10.1182/blood.2025029360.
PubMed 40983036Pillarisetti K, Powers G, Luistro L, Babich A, Baldwin E, Li Y, Zhang X, Mendonca M, Majewski N, Nanjunda R, Chin D, Packman K, Elsayed Y, Attar R, Gaudet F. Teclistamab is an active T cell-redirecting bispecific antibody against B-cell maturation antigen for multiple myeloma. Blood Adv. 2020 Sep 22;4(18):4538-4549. doi: 10.1182/bloodadvances.2020002393.
PubMed 32956453
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Subjects With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04108195
- Acronym / sponsor ID
- CR108620
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2020 (actual)
- Primary completion
- 7 Apr 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Sep 2019 (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.
The purpose of this study is to identify recommended Phase 2 doses (RP2Ds) for each treatment combination (between daratumumab plus talquetamab and teclistamab plus daratumumab with or without pomalidomide) and to characterize the safety of each RP2D for selected treatment combinations.
Detailed description
Multiple myeloma is a malignant plasma cell disorder characterized by osteolytic lesions, increased susceptibility to infections, hypercalcemia, and renal failure. Overall rationale of study is that daratumumab in combination with talquetamab or teclistamab with or without pomalidomide may lead to enhanced clinical responses in treatment of relapsed or refractory multiple myeloma through multiple mechanisms of action. Daratumumab is human immunoglobulin G1 kappa monoclonal antibody (IgG1k) that binds with high affinity to a unique epitope on cluster of differentiation 38 (CD38) in a variety of hematological malignancies including multiple myeloma. Talquetamab and teclistamab are bispecific T cell redirection antibodies. Talquetamab binds to cluster of differentiation 3 (CD3) receptor complex on T cells and to G protein-coupled receptor family C group 5-member D (GPRC5D), a 7-transmembrane receptor protein on plasma cells and teclistamab binds to human and cynomolgus-CD3 and B cell maturation antigen (BCMA). Purpose of study is to evaluate safety of daratumumab in combination with talquetamab and teclistamab with or without pomalidomide, and to evaluate preliminary antitumor activity of each combination. Study consists of a screening period, treatment period (Part 1: dose escalation and Part 2: dose expansion), a Post-treatment Follow-up Period (after the last dose of study drug and will continue for up to 16 weeks for each subject), and a Long-term Extension Period. The study will end when one of the following occurs: 1) the study drug has received marketing authorization and, if regionally applicable, government reimbursement is available; 2) a long-term extension rollover study has commenced for participants who are still benefiting from study treatment as determined by their investigator; or 3) all participants have discontinued study treatment. Total duration of study is approximately 5 years and 6 months. Efficacy, safety, pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points. Participants safety will be monitored throughout study by Study Evaluation Team (SET). SET consists of members of sponsor's study team and participating investigators.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose Escalation | Experimental | Drug: Daratumumab, Drug: Talquetamab, Drug: Teclistamab, Drug: PomalidomideParticipants will be assigned to either a combination of 1) daratumumab plus teclistamab or 2) daratumumab plus talquetamab or 3) daratumumab plus talquetamab plus pomalidomide or 4) daratumumab plus teclistamab plus pomalidomide. |
| Part 2: Dose Expansion | Experimental | Drug: Daratumumab, Drug: Talquetamab, Drug: Teclistamab, Drug: PomalidomideParticipants will be treated with the RP2D(s) for selected treatment combinations determined in Part 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
- Must have either of the following: a) received at least 3 prior lines of therapy including a proteasome inhibitor (PI) (greater than or equal to [>=] 2 cycles or 2 months of treatment) and an immunomodulatory drug (IMiD) (>=2 cycles or 2 months of treatment) in any order during the treatment or b) disease that is double refractory to a PI and an IMiD
- Measurable disease at screening as defined by any of the following: Serum monoclonal protein (M-protein) level >=1.0 grams per deciliter (g/dL) (in non- immunoglobulin G (IgG) myeloma, an M-protein level >=0.5 g/dL); or Urine M-protein level >=200 milligrams (mg)/24 hours; or Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 at screening and at Cycle 1, Day 1 predose
- Female participants of childbearing potential must have a negative highly-sensitive serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test (less than [<] 5 international units per milliliter [IU/mL]) at screening and a negative urine or serum pregnancy test within 1 day before the first dose of study drug
Key exclusion criteria (5 listed)
- Treatment in the prior 3 months with an anti- cluster of differentiation 38 (CD38) therapy (example, daratumumab), or discontinuation of a prior anti-CD38 therapy at any time due to an adverse event related to the anti-CD38 therapy
- Live, attenuated vaccine within 4 weeks prior to the first dose of study drug unless approved by sponsor
- Active Central nervous system involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
- Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Participants with resolved infection must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded
- Active hepatitis C infection as measured by positive hepatitis C virus- ribonucleotide (HCV)-RNA testing. Participants with a history of Hepatitis C virus antibody positivity must undergo HCV-RNA testing
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 |
|---|---|---|
| DaratumumabAlso: JNJ-54767414, DarzalexParticipants will receive daratumumab. | Drug | Part 1: Dose Escalation, Part 2: Dose Expansion |
| TalquetamabAlso: JNJ-64407564Participants will receive talquetamab. | Drug | Part 1: Dose Escalation, Part 2: Dose Expansion |
| TeclistamabAlso: JNJ-64007957Participants will receive teclistamab. | Drug | Part 1: Dose Escalation, Part 2: Dose Expansion |
| PomalidomideParticipants will receive pomalidomide. | Drug | Part 1: Dose Escalation, Part 2: Dose Expansion |
Primary outcome
Part 1: Number of Participants With Dose Limiting Toxicity (DLT)
Time frame: Up to 52 Weeks
The dose limiting toxicities are based on drug related adverse events and defined as any of the following events: hematological or non-hematological toxicity of grade 3 or higher.
Part 1: Number of Participants With Dose Limiting Toxicity by Severity
Time frame: Up to 52 Weeks
The dose limiting toxicities are based on drug related adverse events and defined as any of the following events: hematological or non-hematological toxicity of grade 3 or higher.
Part 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 48 Weeks
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product.
Part 2: Number of Participants With Adverse Events and SAEs by Severity
Time frame: Up to 48 Weeks
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product.
13 secondary outcomes
Serum Concentration of Daratumumab
Time frame: Up to 52 Weeks
Serum Concentration of Talquetamab
Time frame: Up to 52 Weeks
Serum Concentration of Teclistamab
Time frame: Up to 52 Weeks
Biomarker Assessment of Daratumumab
Time frame: Up to Cycle 7 Day 1 (each cycle of 28-days)
Biomarker Assessment of Talquetamab
Time frame: Up to Cycle 7 Day 1 (each cycle of 28-days)
Biomarker Assessment of Teclistamab
Time frame: Up to Cycle 7 Day 1 (each cycle of 28-days)
Number of Participants With Anti-Drug Antibodies to Daratumumab
Time frame: Up to 52 Weeks
Number of Participants With Anti-Drug Antibodies to Talquetamab
Time frame: Up to 52 Weeks
Number of Participants With Anti-Drug Antibodies to Teclistamab
Time frame: Up to 52 Weeks
Overall Response Rate (ORR)
Time frame: Up to 48 Weeks
Clinical Benefit Rate
Time frame: Up to 48 Weeks
Duration of Response (DOR)
Time frame: Up to 48 Weeks
Time to Response
Time frame: Up to 48 Weeks
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 3 Nov 2026.
- Derived from this study: PubMed 42685673Rodriguez-Otero P, Morillo D, D'Souza A, Reece D, van de Donk N, Chari A, Dholaria B, Kortum KM, Mateos MV, Mckay JT, Rosinol L, Sureda A, Wasch R, Bhutani M, Weisel KC, Bahlis NJ, Vishwamitra D, Skerget S, Bakshi KK, Guo Y, Sun W, Goldberg JD, Stephenson T, Prior TJ, Vandenberk L, Lee S, Smit MD, Verona RI, Oriol A, Krishnan A. Teclistamab and Daratumumab Immune-Based Doublet Therapy for Relapsed/Refractory Multiple Myeloma: the TRIMM-2 Study. Blood Adv. 2026 Sep 2:bloodadvances.2026020648. doi: 10.1182/bloodadvances.2026020648. Online ahead of print.
- Derived from this study: PubMed 40983036Chari A, van de Donk NWCJ, Dholaria B, Weisel K, Mateos MV, Goldschmidt H, Martin TG, Morillo D, Reece D, Rodriguez-Otero P, Bhutani M, D'Souza A, Oriol A, Rosinol L, Bahlis NJ, Vishwamitra D, Skerget S, Verona RI, Bakshi K, Kang L, Prior TJ, Vandenberk L, Tolbert J, Lee S, Smit MD, Wasch R. Talquetamab plus daratumumab for the treatment of relapsed or refractory multiple myeloma in the TRIMM-2 study. Blood. 2025 Dec 11;146(24):2902-2913. doi: 10.1182/blood.2025029360.
- Derived from this study: PubMed 32956453Pillarisetti K, Powers G, Luistro L, Babich A, Baldwin E, Li Y, Zhang X, Mendonca M, Majewski N, Nanjunda R, Chin D, Packman K, Elsayed Y, Attar R, Gaudet F. Teclistamab is an active T cell-redirecting bispecific antibody against B-cell maturation antigen for multiple myeloma. Blood Adv. 2020 Sep 22;4(18):4538-4549. doi: 10.1182/bloodadvances.2020002393.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
24 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Daratumumab, Talquetamab and Teclistamab in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 24 sites in 5 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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Spain, Germany, Canada, Netherlands. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Number of Participants With Dose Limiting Toxicity (DLT) (time frame: Up to 52 Weeks). The study lists 4 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 NCT04108195, which also lists 3 linked publications.
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 3 Nov 2026.