Comparing 3 approaches for multiple myeloma
Official title: A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma
A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab SC and Lenalidomide (Tal-DR) Versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Either Ineligible or Not Intended for Autologous Stem Cell Transplant as Initial Therapy
- Phase 3
- 3 groups
- Sites in Calgary, Edmonton and 3 more cities
- Recruiting
Interventions (5)
- Medication
Teclistamab
Teclistamab will be administered as SC injection.
- Medication
Daratumumab
Daratumumab will be administered as SC injection.
- Medication
Lenalidomide
Lenalidomide will be administered orally.
- Medication
Dexamethasone
Dexamethasone will be administered either orally or intravenously (IV).
- Medication
Talquetamab
Talquetamab will be administered as SC injection.
Canadian Sites (5)
1 of 5 recruiting
- Recruiting
Lakeridge Health Oshawa
Oshawa, Ontario
- Not currently recruiting
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta
- Completed
Cross Cancer Institute
Edmonton, Alberta
- Not currently recruiting
British Columbia Cancer Agency
Vancouver, British Columbia
- Not currently recruiting
CHU de Quebec L Hotel Dieu de Quebec
Québec, Quebec
Eligibility Criteria
See who this study is looking for11 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- +Have a diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria
- +A participant must agree not to plan to father a child while enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in this study or within 100 days after the last dose of study treatment
- +A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
- +Be newly diagnosed and not considered a candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to: ineligible due to advanced age OR; ineligible due to the presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT OR; deferral of high-dose chemotherapy with ASCT as initial treatment
Exclusion
- −Known allergies, hypersensitivity, or intolerance to teclistamab or talquetamab excipients
- −Received any prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids (not to exceed total of 160 milligrams \[mg\] dexamethasone or equivalent). In addition, received a cumulative dose of systemic corticosteroids equivalent to greater than or equals to (\>=) 20 mg of dexamethasone within 14 days before randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
- −Had plasmapheresis within 28 days of randomization
- −Had a stroke, transient ischemic attack, or seizure within 6 months prior to randomization
- −Known contraindications to the use of daratumumab or lenalidomide per local prescribing information
- −Myeloma Frailty Index of \>=2 with the exception of participants who have a score of 2 based on age alone
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Group A receives Teclistamab, Daratumumab and Lenalidomide.
Registry label: A: Teclistamab, Daratumumab SC, and Lenalidomide (Tec-DR)
Group B receives Talquetamab, Daratumumab and Lenalidomide.
Registry label: B: Talquetamab, Daratumumab SC, and Lenalidomide (Tal-DR)
Group C, the comparison group, receives Daratumumab, Lenalidomide and Dexamethasone.
Registry label: C: Daratumumab SC, Lenalidomide, and Dexamethasone (DRd)
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 1,590 people.
The study is currently expected to finish around October 2033.
The main measurement is taken over: From randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → to the date of disease progression or death (Up to 09 years).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Progression Free Survival (PFS) — measured over From randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → to the date of disease progression or death (Up to 09 years).
12-Month Minimal Residual Disease (MRD)-Negative Complete Response (CR) — measured over At Month 12.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05552222 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About TeclistamabDrug
Teclistamab will be administered as SC injection.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About DaratumumabDrug
Daratumumab will be administered as SC injection.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About LenalidomideDrug
Lenalidomide will be administered orally.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About DexamethasoneDrug
Dexamethasone will be administered either orally or intravenously (IV).
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About TalquetamabDrug
Talquetamab will be administered as SC injection.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → to the date of disease progression or death (Up to 09 years).
The study as a whole is currently expected to finish around 2033-10-28.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 1,590 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 15 locations, including: Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; Oshawa, Ontario, Canada; Québec, Quebec, Canada; Ann Arbor, Michigan, United States, and 9 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The purpose of this study is to compare the efficacy of teclistamab in combination with daratumumab and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab and lenalidomide (Tal-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).
Other Sites (12)
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Cancer - Detroit Brigitte Harris Cancer Pavilion
Detroit, Michigan, United States
Cancer And Hematology Centers of Western Michigan PC
Grand Rapids, Michigan, United States
Henry Ford Providence Novi Hospital
Novi, Michigan, United States
Henry Ford Providence Southfield CK Potluri Cancer Center
Southfield, Michigan, United States
Hematology-Oncology Associates of CNY
East Syracuse, New York, United States
Northwell Health Cancer Institute
Lake Success, New York, United States
NYU Langone Hospital Long Island
Mineola, New York, United States
Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
NorthWest Medical Specialties, PLLC
Tacoma, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.