Multiple MyelomaPhase 1MonumenTAL-2NCT05050097
A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma
A Phase 1 study testing Talquetamab, Carfilzomib and Daratumumab SC in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 31 sites in 6 countries.
Trial summary
The purpose of this study is to characterize the safety and tolerability of talquetamab when administered in different combination regimens and to identify the safe dose(s) of talquetamab combination regimens. 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?
- Talquetamab, Carfilzomib and Daratumumab SC
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 31 sitesin 6 countries
- Study dates
- 22 Sep 2021to 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
- Have documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
- Have measurable disease at screening as defined by at least 1 of the following: a. Serum monoclonal protein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL); or b. Urine M-protein level >= 200 milligrams (mg)/24 hours; or c. 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
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at screening and immediately before the start of study treatment administration
- A woman of childbearing potential must have a negative highly sensitive serum beta human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours before the start of study treatment administration
- Be willing and able to adhere to the lifestyle restrictions specified in the protocol, including adherence to the applicable immunomodulatory drug (IMiD) global Pregnancy Prevention Plan (PPP) or local PPP/Risk Evaluation and Mitigation Strategy (REMS) program
Who cannot join
- Live, attenuated vaccine within 4 weeks before the first dose of study treatment
- Received a cumulative dose of corticosteroids equivalent to >=140 mg of prednisone within the 14-day period before the start of study treatment administration
- Active central nervous system (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
- Known to be seropositive for human immunodeficiency virus
- History of stroke or seizure within 6 months prior to the first dose of study treatment
Trial locations and contacts
31 sites in 6 countries.
31 sites in 6 countries
United States12 sites
Emory University
Atlanta, Georgia, 30322
University of Alabama Birmingham
Birmingham, Alabama, 35294
Levine Cancer Institute
Charlotte, North Carolina, 28204
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Indiana University
Indianapolis, Indiana, 46202
Medical College Of Wisconsin
Milwaukee, Wisconsin, 53226
Tennessee Oncology
Nashville, Tennessee, 37203
Mt. Sinai School of Medicine
New York, New York, 10029
Weill Cornell Medical College
New York, New York, 10065
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
University of California San Francisco
San Francisco, California, 94143
Australia4 sites
St Vincents Hospital Melbourne
Fitzroy, 3065
Alfred Health
Melbourne, 3004
Gold Coast University Hospital
Southport, 4215
Wollongong Hospital
Wollongong, 2500
Belgium4 sites
Cliniques Universitaires St-Luc
Brussels, 1200
UZA
Edegem, 2650
UZ Gent
Ghent, 9000
UZ Leuven
Leuven, 3000
France4 sites
CHU Nantes
Nantes, 44093
CHU de Bordeaux - Hospital Haut-Leveque
Pessac, 33604
Chu Rennes Hopital Pontchaillou
Rennes, 35000
Institut Universitaire du cancer de Toulouse-Oncopole
Toulouse, 31059
United Kingdom4 sites
University College Hospital London
London, W1T 7HA
The Christie Nhs Foundation Trust
Manchester, M20 4BX
Churchill Hospital
Oxford, OX3 7LE
The Royal Marsden NHS Trust Sutton
Surrey, SM2 5PT
Netherlands3 sites
UMCG
Groningen, 9713 GZ
Maastricht University Medical Centre
Maastricht, 6229 HX
UMCU
Utrecht, 3584 CX
About this study
Official title: A Multi-arm Phase 1b Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma
The purpose of this study is to characterize the safety and tolerability of talquetamab when administered in different combination regimens and to identify the safe dose(s) of talquetamab combination regimens.
- Conditions
- Multiple Myeloma
- Being tested
- Talquetamab, Carfilzomib, Daratumumab SC, Lenalidomide, 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.
TalquetamabDrug
Also called JNJ-64407564
Talquetamab will be administered subcutaneously.
CarfilzomibDrug
Carfilzomib will be administered as an IV infusion.
Daratumumab SCDrug
Daratumumab will be administered subcutaneously.
LenalidomideDrug
Lenalidomide will be self-administered orally.
PomalidomideDrug
Pomalidomide will be self-administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Regimen A: Talquetamab + Carfilzomib | Experimental | Participants assigned to Treatment regimen A will receive talquetamab subcutaneously (SC) in combination with carfilzomib as an intravenous (IV) infusion. Receives: Drug: Talquetamab; Drug: Carfilzomib |
| Treatment Regimen B: Talquetamab + Daratumumab + Carfilzomib | Experimental | Participants assigned to Treatment regimen B will receive talquetamab SC in combination with daratumumab SC and carfilzomib as an IV infusion. Receives: Drug: Talquetamab; Drug: Carfilzomib; Drug: Daratumumab SC |
| Treatment Regimen C: Talquetamab + Lenalidomide | Experimental | Participants assigned to Treatment regimen C will receive talquetamab SC in combination with lenalidomide orally. Receives: Drug: Talquetamab; Drug: Lenalidomide |
| Treatment Regimen D: Talquetamab + Daratumumab + Lenalidomide | Experimental | Participants assigned to Treatment regimen D will receive talquetamab SC in combination with daratumumab SC and lenalidomide orally. Receives: Drug: Talquetamab; Drug: Daratumumab SC; Drug: Lenalidomide |
| Treatment Regimen E: Talquetamab + Pomalidomide | Experimental | Participants assigned to Treatment regimen E will receive talquetamab SC in combination with pomalidomide orally. Receives: Drug: Talquetamab; Drug: Pomalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Measured: Up to 1 year and 10 months
Number of Participants with AEs by Severity
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to AE.
Measured: Up to 1 year and 10 months
Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
Number of participants with clinically significant abnormalities in laboratory parameters such as hematology and serum chemistry will be reported.
Measured: Up to 1 year and 6 months
Number of Participants with Dose Limiting Toxicity (DLT)
Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity of grade 3 or higher, clinical laboratory abnormalities, or hematologic toxicity.
Measured: Up to 49 days
Secondary outcomes (11)
Overall Response Rate (ORR)
ORR is defined as the percentage of participants who achieve partial response (PR) or better according to the International Myeloma Working Group (IMWG) 2016 criteria. Response to treatment will be evaluated by the investigator based on IMWG criteria.
Measured: Up to 1 year and 10 months
Very Good Partial Response (VGPR) or Better Response Rate
VGPR or better response rate is defined as the percentage of participants who achieve a VGPR or better response (stringent complete response [sCR] + complete response [CR] +VGPR) according to the IMWG 2016 criteria.
Measured: Up to 1 year and 10 months
Complete Response (CR) or Better Response Rate
CR or better response rate is defined as the percentage of participants who achieve a CR or better response (sCR+CR) according to the IMWG 2016 criteria.
Measured: Up to 1 year and 10 months
Stringent Complete Response (sCR)
sCR rate is defined as the percentage of participants who achieve an sCR according to the IMWG 2016 criteria.
Measured: Up to 1 year and 10 months
Duration of Response
Duration of response is defined as 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 2016 criteria, or death due to disease progression, whichever occurs first.
Measured: Up to 1 year and 10 months
Time to Response
Time to response is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participant has met all criteria for PR or better.
Measured: Up to 1 year and 10 months
Serum Concentration of Talquetamab
Serum samples will be analyzed to determine concentrations of talquetamab.
Measured: Up to 1 year and 10 months
Serum Concentration of Daratumumab
Serum samples will be analyzed to determine concentrations of daratumumab for treatment regimens B and D.
Measured: Up to 1 year and 10 months
Number of Participants with Anti-Drug Antibodies to Talquetamab
Number of participants with anti-drug antibodies to talquetamab will be reported.
Measured: Up to 1 year and 10 months
Number of Participants with Anti-Drug Antibodies to Daratumumab
Number of participants with anti-drug antibodies to daratumumab will be reported for treatment regimens B and D.
Measured: Up to 1 year and 10 months
Number of Participants with Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20)
Number of participants with anti-drug antibodies to rHuPH20 will be reported.
Measured: Up to 1 year and 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start22 Sep 2021
- Primary completion31 Mar 2025
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 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
- NCT05050097
- Sponsor's protocol ID
- CR108946
- Other IDs
- 64407564MMY1004, 2020-004502-55, 2023-503620-60-00, 2023
- Acronym
- MonumenTAL-2
- Status last verified
- Nov 2026
- First submitted
- 10 Sep 2021
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and 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
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 Multi-arm Phase 1b Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05050097
- Acronym / sponsor ID
- MonumenTAL-2 / CR108946
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Sep 2021 (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 characterize the safety and tolerability of talquetamab when administered in different combination regimens and to identify the safe dose(s) of talquetamab combination regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment Regimen A: Talquetamab + Carfilzomib | Experimental | Drug: Talquetamab, Drug: CarfilzomibParticipants assigned to Treatment regimen A will receive talquetamab subcutaneously (SC) in combination with carfilzomib as an intravenous (IV) infusion. |
| Treatment Regimen B: Talquetamab + Daratumumab + Carfilzomib | Experimental | Drug: Talquetamab, Drug: Carfilzomib, Drug: Daratumumab SCParticipants assigned to Treatment regimen B will receive talquetamab SC in combination with daratumumab SC and carfilzomib as an IV infusion. |
| Treatment Regimen C: Talquetamab + Lenalidomide | Experimental | Drug: Talquetamab, Drug: LenalidomideParticipants assigned to Treatment regimen C will receive talquetamab SC in combination with lenalidomide orally. |
| Treatment Regimen D: Talquetamab + Daratumumab + Lenalidomide | Experimental | Drug: Talquetamab, Drug: Daratumumab SC, Drug: LenalidomideParticipants assigned to Treatment regimen D will receive talquetamab SC in combination with daratumumab SC and lenalidomide orally. |
| Treatment Regimen E: Talquetamab + Pomalidomide | Experimental | Drug: Talquetamab, Drug: PomalidomideParticipants assigned to Treatment regimen E will receive talquetamab SC in combination with pomalidomide orally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
- Have measurable disease at screening as defined by at least 1 of the following: a. Serum monoclonal protein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL); or b. Urine M-protein level >= 200 milligrams (mg)/24 hours; or c. 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
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at screening and immediately before the start of study treatment administration
- A woman of childbearing potential must have a negative highly sensitive serum beta human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours before the start of study treatment administration
- Be willing and able to adhere to the lifestyle restrictions specified in the protocol, including adherence to the applicable immunomodulatory drug (IMiD) global Pregnancy Prevention Plan (PPP) or local PPP/Risk Evaluation and Mitigation Strategy (REMS) program
Key exclusion criteria (5 listed)
- Live, attenuated vaccine within 4 weeks before the first dose of study treatment
- Received a cumulative dose of corticosteroids equivalent to >=140 mg of prednisone within the 14-day period before the start of study treatment administration
- Active central nervous system (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
- Known to be seropositive for human immunodeficiency virus
- History of stroke or seizure within 6 months prior to the first dose of study treatment
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 |
|---|---|---|
| TalquetamabAlso: JNJ-64407564Talquetamab will be administered subcutaneously. | Drug | Treatment Regimen A: Talquetamab + Carfilzomib, Treatment Regimen B: Talquetamab + Daratumumab + Carfilzomib, Treatment Regimen C: Talquetamab + Lenalidomide, Treatment Regimen D: Talquetamab + Daratumumab + Lenalidomide, Treatment Regimen E: Talquetamab + Pomalidomide |
| CarfilzomibCarfilzomib will be administered as an IV infusion. | Drug | Treatment Regimen A: Talquetamab + Carfilzomib, Treatment Regimen B: Talquetamab + Daratumumab + Carfilzomib |
| Daratumumab SCDaratumumab will be administered subcutaneously. | Drug | Treatment Regimen B: Talquetamab + Daratumumab + Carfilzomib, Treatment Regimen D: Talquetamab + Daratumumab + Lenalidomide |
| LenalidomideLenalidomide will be self-administered orally. | Drug | Treatment Regimen C: Talquetamab + Lenalidomide, Treatment Regimen D: Talquetamab + Daratumumab + Lenalidomide |
| PomalidomidePomalidomide will be self-administered orally. | Drug | Treatment Regimen E: Talquetamab + Pomalidomide |
Primary outcome
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Time frame: Up to 1 year and 10 months
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Number of Participants with AEs by Severity
Time frame: Up to 1 year and 10 months
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to AE.
Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
Time frame: Up to 1 year and 6 months
Number of participants with clinically significant abnormalities in laboratory parameters such as hematology and serum chemistry will be reported.
Number of Participants with Dose Limiting Toxicity (DLT)
Time frame: Up to 49 days
Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity of grade 3 or higher, clinical laboratory abnormalities, or hematologic toxicity.
11 secondary outcomes
Overall Response Rate (ORR)
Time frame: Up to 1 year and 10 months
Very Good Partial Response (VGPR) or Better Response Rate
Time frame: Up to 1 year and 10 months
Complete Response (CR) or Better Response Rate
Time frame: Up to 1 year and 10 months
Stringent Complete Response (sCR)
Time frame: Up to 1 year and 10 months
Duration of Response
Time frame: Up to 1 year and 10 months
Time to Response
Time frame: Up to 1 year and 10 months
Serum Concentration of Talquetamab
Time frame: Up to 1 year and 10 months
Serum Concentration of Daratumumab
Time frame: Up to 1 year and 10 months
Number of Participants with Anti-Drug Antibodies to Talquetamab
Time frame: Up to 1 year and 10 months
Number of Participants with Anti-Drug Antibodies to Daratumumab
Time frame: Up to 1 year and 10 months
Number of Participants with Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20)
Time frame: Up to 1 year and 10 months
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.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and 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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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
31 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Talquetamab, Carfilzomib and Daratumumab SC in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 31 sites in 6 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 31 sites in United States, Australia, Belgium, France, United Kingdom and 1 more country. 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?
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability (time frame: Up to 1 year and 10 months). 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?
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.