A study comparing talquetamab in combination with daratumumab or in combination with daratumumab and pomalidomide versus daratumumab in combination with pomalidomide and dexamethasone in participants with multiple myeloma that returns after treatment or is resistant to treatment
| ISRCTN | ISRCTN12220131 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12220131 |
| EudraCT/CTIS number | 2021-000202-22 |
| IRAS number | 1006071 |
| ClinicalTrials.gov number | NCT05455320 |
| Secondary identifying numbers | 64407564MMY3002, IRAS 1006071, CPMS 52938 |
- Submission date
- 26/10/2022
- Registration date
- 09/02/2023
- Last edited
- 06/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Multiple myeloma is a blood cancer that affects certain types of white blood cells called plasma cells. Although treatments are available, multiple myeloma can come back after treatment or be resistant to standard treatment. Drugs that induce the body's T cells (a type of white blood cell) to attack cancer cells may be an effective way to destroy cancer cells. Talquetamab (JNJ-64407564) is a modified antibody that binds to T cells and myeloma cells. Talquetamab activates the T cells, which leads to the killing of myeloma cells. In this study, the researchers want to study whether Tal-DP and Tal-D keep the participants’ cancer from getting worse for a longer period compared to DPd.
Who can participate?
Patients aged 18 years or older with multiple myeloma that has either come back after treatment or is resistant to standard treatment, who have received at least one prior anticancer therapy
What does the study involve?
The study will be conducted as:
1. Screening (28 days)
2. Treatment phase: participants will receive one of three treatments in a 28-day cycle:
2.1. Talquetamab subcutaneous (SC; as an injection under skin) in combination with daratumumab subcutaneous (SC; as an injection under skin) and pomalidomide (Tal-DP) orally
2.2. Daratumumab SC in combination with pomalidomide orally and dexamethasone (DPd) either orally or as an injection in the veins
2.3. Talquetamab SC in combination with daratumumab SC (Tal-D)
3. Posttreatment follow-up phase: participants will be followed up for safety until death, withdrawal of consent, or end of the study, whichever occurs first
During the study, some tests will be performed, such as blood tests, physical and neurologic examinations, vital signs, Eastern Cooperative Oncology Group (ECOG) performance status and questionnaires. Blood samples will be taken at multiple timepoints to see how the body responds to treatment. Disease status will be checked based on International Myeloma Working Group (IMWG) criteria for multiple myeloma. Side effects will be recorded until the study ends (up to 6 years 6 months).
What are the possible benefits and risks of participating?
Based on scientific theory, taking talquetamab may improve multiple myeloma. However, this cannot be guaranteed because talquetamab is still under investigation as a treatment and it is not known whether talquetamab will work.
Participants may experience some benefit from participation in the study that is not due to receiving talquetamab, but rather is due to regular visits and assessments monitoring overall health. Participation in the study may help other people with multiple myeloma in the future.
Participants may have side effects from the drug(s) or procedures used in this study that may be mild to severe and even life-threatening, and they can vary from person to person. The most common, known risks are getting symptoms such as cytokine release syndrome (CRS), cytopenias, skin and nail changes, oral side-effects, infection, injection-site reactions, and increased risk for immune effector cell-associated neurotoxicity syndrome (ICANS). The participant information sheet and informed consent form, which will be signed by every participant agreeing to participate in the study, includes a detailed section outlining the known risks of participating in the study. Not all possible side effects and risks related to talquetamab are known at this moment. During the study, the sponsor may learn new information about talquetamab. The study doctor will tell participants as soon as possible about any new information that might make them change their mind about being in the study, such as new risks.
To minimise the risk associated with taking part in the study, participants are frequently looked at and asked about any side effects and other medical events. Participants are educated to report any such events to the study doctor, who will provide appropriate medical care. Any serious side effects that are reported to the sponsor are thoroughly reviewed by a drug safety team. There are no costs to participants to be in the study. The sponsor will pay for the study drug and tests that are part of the study. The participant will receive reasonable reimbursement for study-related costs (for example, travel/parking costs).
Where is the study run from?
Janssen (Netherlands)
When is the study starting and how long is it expected to run for?
January 2021 to September 2029
Who is funding the study?
Janssen (Netherlands)
Who is the main contact?
Dogan Colakoglu, JanssenUKRegistryQueries@its.jnj.com
Contact information
Scientific
50-100 Holmers Farm Way
High Wycombe
HP12 4DP
United Kingdom
| Phone | +44 (0)7443742758 |
|---|---|
| JanssenUKRegistryQueries@its.jnj.com |
Principal Investigator
Derriford Road
Plymouth
PL6 8DH
United Kingdom
Scientific
Janssen Research and Development
50-100 Holmers Farm Way
High Wycombe
HP12 4DP
United Kingdom
| Phone | +44 (0)800 731 8450 |
|---|---|
| medinfo@its.jnj.com |
Study information
| Study design | Randomized controlled open trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | A Phase III randomized study comparing talquetamab in combination with daratumumab (SC) and pomalidomide (Tal-DP) or talquetamab (SC) in combination with daratumumab SC (Tal-D) versus daratumumab SC, pomalidomide and dexamethasone (DPd), in participants with relapsed or refractory multiple myeloma who have received at least one prior line of therapy |
| Study acronym | MonumenTAL-3 |
| Study objectives | The overall rationale of the study is that combination treatments of talquetamab, daratumumab, pomalidomide and dexamethasone may lead to enhanced clinical responses in treatment of relapsed or refractory multiple myeloma through multiple mechanisms of action. |
| Ethics approval(s) |
Approved 19/01/2023, West Midlands - Edgbaston Research Ethics Committee (3rd Floor Barlow House, Minshull Street, Manchester, M1 3DZ, United Kingdom; +44 207 104 8357; edgbaston.rec@hra.nhs.uk), ref: 22/WM/0261 |
| Health condition(s) or problem(s) studied | Relapsed or refractory multiple myeloma |
| Intervention | Central randomisation will be implemented in this study. Participants will be randomly assigned to one of three treatment arms based on a computer-generated randomisation schedule prepared before the study by or under the supervision of the sponsor. Experimental: Arm A: Talquetamab Subcutaneous (SC) in Combination With Daratumumab SC and Pomalidomide (Tal-DP) Participants will receive talquetamab and daratumumab as SC injections; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug. Drug: Talquetamab Talquetamab will be administered subcutaneously. Other Name: JNJ-64407564 Drug: Daratumumab Daratumumab will be administered subcutaneously. Drug: Pomalidomide Pomalidomide will be administered orally. Drug: Dexamethasone Dexamethasone will be administered orally or intravenously. Experimental: Arm B: Daratumumab in Combination With Pomalidomide and Dexamethasone (DPd) Participants will receive daratumumab as an SC injection; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug. Drug: Daratumumab Daratumumab will be administered subcutaneously. Drug: Pomalidomide Pomalidomide will be administered orally. Drug: Dexamethasone Dexamethasone will be administered orally or intravenously Experimental: Arm C: Talquetamab SC in Combination With Daratumumab SC (Tal-D) Participants will receive talquetamab and daratumumab as injection SC injections; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug. Drug: Talquetamab Talquetamab will be administered subcutaneously. Other Name: JNJ-64407564 Drug: Daratumumab Daratumumab will be administered subcutaneously. Drug: Dexamethasone Dexamethasone will be administered orally or intravenously. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Talquetamab, daratumumab, pomalidomide, dexamethasone |
| Primary outcome measure | Progression-free survival (PFS), defined as the time interval between the date of randomisation to the date of either disease progression or death due to any cause, whichever comes first, measured up to 6 years 6 months. |
| Secondary outcome measures | Current secondary outcome measures as of 07/11/2023: 1. Overall response (partial response [PR] or better), defined as the percentage of participants who have a PR or better according to International Myeloma Working Group (IMWG) criteria, measured up to 6 years 6 months. 2. Very good partial response (VGPR) or better rate, defined as the percentage of participants who achieve a VGPR or better according to IMWG response criteria, measured up to 6 years 6 months. 3. Complete response (CR) or better rate, defined as the percentage of participants who achieve CR or better according to IMWG response criteria, measured up to 6 years 6 months. 4. Overall minimal residual disease (MRD) negative status, defined as a proportion of participants who achieve MRD negativity (at a threshold of 10^-5), at any timepoint after the first dose of the study drug and before disease progression or the start of subsequent antimyeloma therapy, measured up to 6 years 6 months. 5. Overall survival (OS), defined as the time from the date of randomisation to the date of the participant's death, measured up to 6 years 6 months. 6. Progression-free survival on next-line therapy (PFS2), defined as the time interval between the date of randomisation and the date of the event, which is defined as progressive disease as assessed by the investigator on the first subsequent line of antimyeloma therapy, or death from any cause, whichever occurs first, measured up to 6 years 6 months. 7. Time to next therapy (TTNT), defined as the time from randomisation to the start of subsequent antimyeloma treatment, measured up to 6 years 6 months. 8. Number of participants with adverse events (AEs), which 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 6 years 6 months. 9. Number of participants with AEs by severity, where severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), measured up to 6 years 6 months. 10. Serum concentrations of talquetamab, measured using an electrochemiluminescence-based immunoassay (ECLIA) up to 6 years 6 months 11. Serum concentrations of daratumumab, measured using an electrochemiluminescence-based immunoassay (ECLIA) up to 6 years 6 months 12. Number of participants with the presence of anti-drug antibodies (ADAs) to talquetamab, measured using an electrochemiluminescence-based immunoassay (ECLIA) up to 6 years 6 months 13. Number of participants with the presence of anti-drug antibodies (ADAs) to daratumumab, measured using an electrochemiluminescence-based immunoassay (ECLIA) up to 6 years 6 months 14. Time to worsening in symptoms, functioning, and overall health-related quality of life (HRQoL) as assessed by multiple myeloma symptom and impact questionnaire (MySIm-Q), a disease-specific patient-reported outcome (PRO) assessment complementary to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC-QLQ-C30), measured up to 6 years 6 months. 15. Time to worsening in symptoms, functioning, and HRQoL as assessed by PROMIS Short Form Version 2.0 –Physical Functioning 8c, an 8-item fixed-length short form derived from the PROMIS Physical Function item bank, measured up to 6 years 6 months. 16. Time to worsening in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30, measured up to 6 years 6 months. 17. Time to worsening in symptoms, functioning, and HRQoL as assessed by PRO-CTCAE, an item library of common AEs experienced by people with cancer that are appropriate for self-reporting of treatment tolerability, measured up to 6 years 6 months. 18. Time to worsening in symptoms, functioning, and HRQoL as assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L) a generic measure of health status. For purposes of this study, the EQ-5D-5L will be used to generate utility scores for use in cost-effectiveness analyses, measured up to 6 years 6 months. 19. Time to worsening in symptoms, functioning, and HRQoL as assessed by Patient Global Impression - Severity (PGI-S) which will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and PROMIS SF PF 8c in this population, measured up to 6 years 6 months. 20. Change from baseline in symptoms, functioning, and overall HRQoL as assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q), a disease-specific PRO assessment complementary to the EORTC-QLQ-C30, measured from baseline up to 6 years 6 months. 21. Change from baseline in symptoms, functioning, and HRQoL as assessed by PROMIS Short Form Version 2.0 –Physical Functioning 8c, an 8-item fixed-length short form derived from the PROMIS Physical Function item bank, measured from baseline up to 6 years 6 months. 22. Change from baseline in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30, measured from baseline up to 6 years 6 months. 23. Change from baseline in symptoms, functioning, and HRQoL as assessed by PRO-CTCAE an item library of common AEs experienced by people with cancer that are appropriate for self-reporting of treatment tolerability, measured from baseline up to 6 years 6 months. 24. Change from baseline in symptoms, functioning, and HRQoL as assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L) a generic measure of health status. For purposes of this study, the EQ-5D-5L will be used to generate utility scores for use in cost-effectiveness analyses, measured from baseline up to 6 years 6 months. 25. Change from baseline in symptoms, functioning, and HRQoL as assessed by Patient Global Impression - Severity (PGI-S), which will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and PROMIS SF PF 8c in this population, measured from baseline up to 6 years 6 months. _____ Previous secondary outcome measures: 1. Overall response (partial response [PR] or better), defined as the percentage of participants who have a PR or better according to International Myeloma Working Group (IMWG) criteria, measured up to 6 years 6 months. 2. Very good partial response (VGPR) or better rate, defined as the percentage of participants who achieve a VGPR or better according to IMWG response criteria, measured up to 6 years 6 months. 3. Complete response (CR) or better rate, defined as the percentage of participants who achieve CR or better according to IMWG response criteria, measured up to 6 years 6 months. 4. Overall minimal residual disease (MRD) negative status, defined as the percentage of participants who achieve MRD negativity (at a threshold of 10^-5), at any timepoint after the first dose of the study drug and before disease progression or the start of subsequent antimyeloma therapy, measured up to 6 years 6 months. 5. Overall survival (OS), defined as the time from the date of the first dose of the study drug to the date of the participant's death, measured up to 6 years 6 months. 6. Progression-free survival on next-line therapy (PFS2), defined as the time interval between the date of the first dose of the study drug and the date of the event, which is defined as progressive disease as assessed by the investigator on the first subsequent line of antimyeloma therapy, or death from any cause, whichever occurs first, measured up to 6 years 6 months. 7. Time to next therapy (TTNT), defined as the time from the first dose of the study drug to the start of subsequent antimyeloma treatment, measured up to 6 years 6 months. 8. Number of participants with adverse events (AEs), which 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 6 years 6 months. 9. Number of participants with AEs by severity, where severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), measured up to 6 years 6 months. 10. Serum concentrations of talquetamab, measured using an electrochemiluminescence-based immunoassay (ECLIA) up to 6 years 6 months 11. Number of participants with the presence of anti-drug antibodies (ADAs) to talquetamab, measured using an electrochemiluminescence-based immunoassay (ECLIA) up to 6 years 6 months 12. Number of participants with the presence of anti-drug antibodies (ADAs) to daratumumab, measured using an electrochemiluminescence-based immunoassay (ECLIA) up to 6 years 6 months 13. Time to worsening in symptoms, functioning, and overall health-related quality of life (HRQoL) as assessed by multiple myeloma symptom and impact questionnaire (MySIm-Q), a disease-specific patient-reported outcome (PRO) assessment complementary to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC-QLQ-C30), measured up to 6 years 6 months. 14. Time to worsening in symptoms, functioning, and HRQoL as assessed by PROMIS Short Form Version 2.0 –Physical Functioning 8c, an 8-item fixed-length short form derived from the PROMIS Physical Function item bank, measured up to 6 years 6 months. 15. Time to worsening in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30, measured up to 6 years 6 months. 16. Time to worsening in symptoms, functioning, and HRQoL as assessed by PRO-CTCAE, an item library of common AEs experienced by people with cancer that are appropriate for self-reporting of treatment tolerability, measured up to 6 years 6 months. 17. Time to worsening in symptoms, functioning, and HRQoL as assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L) a generic measure of health status. For purposes of this study, the EQ-5D-5L will be used to generate utility scores for use in cost-effectiveness analyses, measured up to 6 years 6 months. 18. Time to worsening in symptoms, functioning, and HRQoL as assessed by Patient Global Impression - Severity (PGI-S) which will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and PROMIS SF PF 8c in this population, measured up to 6 years 6 months. 19. Change from baseline in symptoms, functioning, and overall HRQoL as assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q), a disease-specific PRO assessment complementary to the EORTC-QLQ-C30, measured from baseline up to 6 years 6 months. 20. Change from baseline in symptoms, functioning, and HRQoL as assessed by PROMIS Short Form Version 2.0 –Physical Functioning 8c, an 8-item fixed-length short form derived from the PROMIS Physical Function item bank, measured from baseline up to 6 years 6 months. 21. Change from baseline in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30, measured from baseline up to 6 years 6 months. 22. Change from baseline in symptoms, functioning, and HRQoL as assessed by PRO-CTCAE an item library of common AEs experienced by people with cancer that are appropriate for self-reporting of treatment tolerability, measured from baseline up to 6 years 6 months. 23. Change from baseline in symptoms, functioning, and HRQoL as assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L) a generic measure of health status. For purposes of this study, the EQ-5D-5L will be used to generate utility scores for use in cost-effectiveness analyses, measured from baseline up to 6 years 6 months. 24. Change from baseline in symptoms, functioning, and HRQoL as assessed by Patient Global Impression - Severity (PGI-S), which will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and PROMIS SF PF 8c in this population, measured from baseline up to 6 years 6 months. |
| Overall study start date | 13/01/2021 |
| Completion date | 30/09/2029 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 810 |
| Total final enrolment | 864 |
| Key inclusion criteria | Current inclusion criteria as of 20/05/2024: 1. Documented multiple myeloma as defined: 1.1. Multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria 1.2. Measurable disease at screening as defined by any of the following: 1.2.1. Serum M-protein level ≥0.5 g/dL (central laboratory) 1.2.2. Urine M-protein level ≥200 mg/24 hours (central laboratory) 1.2.3. Light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin free light chain ≥10 mg/dL (central laboratory), and abnormal serum immunoglobulin kappa lambda free light chain ratio 2. Relapsed or refractory disease as defined by: 2.1. Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease by IMWG criteria greater than (>) 60 days after cessation of treatment 2.2. Refractory disease is defined as less than (<) 25% reduction in monoclonal paraprotein (M-protein) or confirmed progressive disease by IMWG criteria during previous treatment or less than or equal to (<=) 60 days after cessation of treatment 3. Received at least one prior line of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide. Participants who have received only one prior line of antimyeloma therapy must be considered lenalidomide-refractory (that is, have demonstrated progressive disease by IMWG criteria on or within 60 days of completion of lenalidomide-containing regimen). Participants who have received ≥2 prior lines of antimyeloma therapy must be considered lenalidomide exposed 4. Documented evidence of progressive disease based on the investigator’s determination of response by the IMWG criteria on or after their last regimen 5. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment _____ Previous inclusion criteria: 1. Documented multiple myeloma as defined: 1.1. Multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria 1.2. Measurable disease at screening as defined by any of the following: 1.2.1. Serum M-protein level ≥0.5 g/dL (central laboratory) 1.2.2. Urine M-protein level ≥200 mg/24 hours (central laboratory) 1.2.3. Light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin free light chain ≥10 mg/dL (central laboratory), and abnormal serum immunoglobulin kappa lambda free light chain ratio 2. Relapsed or refractory disease as defined: 2.1. Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease by IMWG criteria >60 days after cessation of treatment 2.2. Refractory disease is defined as <25% reduction in monoclonal paraprotein (M-protein) or confirmed progressive disease by IMWG criteria during previous treatment or less than or equal to 60 days after cessation of treatment 3. Received at least one prior line of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide. Participants who have received only one prior line of antimyeloma therapy must be considered lenalidomide-refractory (that is, have demonstrated progressive disease by IMWG criteria on or within 60 days of completion of lenalidomide-containing regimen). Participants who have received ≥2 prior lines of antimyeloma therapy must be considered lenalidomide exposed 4. Documented evidence of progressive disease based on the investigator’s determination of response by the IMWG criteria on or after their last regimen 5. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment |
| Key exclusion criteria | Current exclusion criteria as of 20/05/2024: 1. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to study drug excipients 2. Disease is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody as defined per IMWG consensus guidelines (progression during treatment or within 60 days of completing therapy with an anti-CD38 monoclonal antibody) 3. Received prior pomalidomide therapy 4. A maximum cumulative dose of corticosteroids to ≥140 mg of prednisone or equivalent within the 14-day period before the first dose of the study drug 5. Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole-brain magnetic resonance imaging (MRI) and lumbar cytology are required 6. Plasma cell leukaemia (per IMWG criteria) at the time of screening, Waldenström's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS syndrome), or primary amyloid light chain amyloidosis _____ Previous exclusion criteria as of 07/11/2023: 1. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to study drug excipients 2. Disease is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody as defined per IMWG consensus guidelines (progression during treatment or within 60 days of completing therapy with an anti-CD38 monoclonal antibody) 3. A maximum cumulative dose of corticosteroids to ≥140 mg of prednisone or equivalent within the 14-day period before the first dose of the study drug 4. Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole-brain magnetic resonance imaging (MRI) and lumbar cytology are required 5. Plasma cell leukaemia (per IMWG criteria) at the time of screening, Waldenström's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS syndrome), or primary amyloid light chain amyloidosis _____ Previous exclusion criteria: 1. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to study drug excipients 2. Disease is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody as defined per IMWG consensus guidelines (progression during treatment or within 60 days of completing therapy with an anti-CD38 monoclonal antibody) 3. A maximum cumulative dose of corticosteroids to ≥140 mg of prednisone or equivalent within the 14-day period before the first dose of the study drug 4. Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole-brain magnetic resonance imaging (MRI) and lumbar cytology are required 5. Plasma cell leukaemia at the time of screening, Waldenström's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS syndrome), or primary amyloid light chain amyloidosis |
| Date of first enrolment | 13/10/2022 |
| Date of final enrolment | 29/03/2024 |
Locations
Countries of recruitment
- Belgium
- Brazil
- China
- Czech Republic
- England
- France
- Germany
- Greece
- Israel
- Italy
- Japan
- Korea, South
- Netherlands
- Poland
- Spain
- Taiwan
- Türkiye
- United Kingdom
- United States of America
Study participating centre
Derriford
Plymouth
PL6 8DH
United Kingdom
Sponsor information
Industry
Archimedesweg 29
Leiden
2333 CM
Netherlands
| Phone | +31 (0)71 524 21 06 |
|---|---|
| ClinicalTrialsEU@its.jnj.com | |
"ROR" |
https://ror.org/04cxegr21 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Janssen R&D, Janssen Research & Development, Janssen Research & Development, LLC, Janssen Research & Development LLC, Janssen Pharmaceutical Companies of Johnson & Johnson, Research & Development at Janssen, JRD, J&J PRD
- Location
- United States of America
Results and Publications
| Intention to publish date | 06/04/2030 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. Peer-reviewed scientific journals 2. Internal report 3. Conference presentation 4. Publication on website 5. Submission to regulatory authorities 6. Other Study results will be available via publication in scientific journals, the EudraCT database and presentation at scientific meetings. Results will be made available to participants via a Plain Language Summary a year after the end of the study. The summary will describe the results regardless of the study outcome in language that is understandable to the general public. It will not contain individual participant results or their personal information. A copy of the Summary will be provided to the REC. |
| IPD sharing plan | The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at https://www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through the Yale Open Data Access (YODA) Project site at yoda.yale.edu. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
06/05/2025: Total final enrolment added.
01/05/2025: Contact details updated. The overall study end date was changed from 06/04/2029 to 30/09/2029.
20/05/2024: The following changes were made to the trial record:
1. The inclusion criteria were changed.
2. The exclusion criteria were changed.
3. The recruitment end date was changed from 07/05/2024 to 29/03/2024.
07/11/2023: The following changes were made to the trial record:
1. The public title was changed from "A study comparing talquetamab in combination with daratumumab or in combination with daratumumab and pomalidomide versus daratumumab in combination with pomalidomide and dexamethasone in participants with relapsed or refractory multiple myeloma" to "A study comparing talquetamab in combination with daratumumab or in combination with daratumumab and pomalidomide versus daratumumab in combination with pomalidomide and dexamethasone in participants with multiple myeloma that returns after treatment or is resistant to treatment".
2. The overall end date was changed from 06/09/2029 to 06/04/2029.
3. The secondary outcome measures were changed.
4. The exclusion criteria were changed.
5. The plain English summary was updated to reflect these changes.
01/03/2023: Internal review.
26/01/2023: ISRCTN received notification of combined HRA/MHRA approval for this trial on 26/01/2023
26/10/2022: Trial's existence confirmed by the HRA.
