A Phase 2 interventional study of Teclistamab and Talquetamab in Multiple Myeloma, sponsored by SCRI Development Innovations, LLC. Recruiting at 17 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by SCRI Development Innovations, LLC · Phase 2, Interventional, and Treatment
This is a phase II study to evaluate the outpatient administration of Teclistamab or Talquetamab in Multiple Myeloma patients
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's planned enrollment of 100 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →SCRI Development Innovations, LLC is the lead sponsor of 179 studies on the registry; 5 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 15 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Teclistamab + Oral Dexamethasone: has an ECOG performance status (Oken 1982) of 0 to 2.
at screening, as assessed by local laboratory, defined by any of the following:
-positive participants are eligible if they meet all of the following:
Exclusion Criteria:
Has myelodysplastic syndrome or active (ie, progressing or requiring treatment change in the last 12 months) other than RRMM. The only allowed exceptions are:
Presence of the following cardiac conditions:
History of prior anti-cancer therapy as follows, before the first dose of study drug:
History of stem cell transplant:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive step up dosing of Teclistamab following the recommended dosage of TECVAYLI™ USPI followed by weekly dosing for twelve 28-day cycles, until disease progression, unacceptable toxicity, or the EOT (end of Cycle 12). Teclistamab dosing may be reduced to once every 2 weeks for participants who achieve partial response (PR) or better after 6 months of therapy.
Drug: Teclistamab · Drug: Tocilizumab
Participants will receive step up dosing of Talquetamab following the recommended dosage of TALVEY™ USPI followed by every 2 week dosing for six 28-day cycles, until disease progression, unacceptable toxicity, or the EOT (end of Cycle 6). Talquetamab dosing may be reduced to once every 4 weeks for participants who achieve very good partial response (VGPR) or better after Cycle 4. Participants in the talquetemab arm cannot be re-screened for or re-enrolled into the teclistamab arm.
Drug: Talquetamab · Drug: Tocilizumab
Participants will receive step-up dosing of Teclistamab followed by weekly dosing for two cycles, every other week during Cycles 3-6 and once every 4 weeks from Cycles 7 through 12 until disease progression, unacceptable toxicity, or the EOT (end of Cycle 12). Teclistamab dosing may be reduced to once every 4 weeks for participants who achieve very good partial response (VGPR) or better starting with Cycle 3.
Drug: Teclistamab · Drug: Oral Dexamethasone
Teclistamab will be administered subcutaneously at step-up doses on Day 1, Day 4 and Day 8, one week after first treatment dose and weekly thereafter. In participants who have a partial response (PR) or better after 6 months of therapy, dosing frequency may be reduced to every 2 weeks.
Also known as: (TECVAYLI™)
Talquetamab will be administered subcutaneously at step-up doses on Day 1, Day 4, Day 8 and Day 15, one week after first treatment dose and every 2 weeks thereafter. In participants who have a very good partial response (VGPR) or better after Cycle 4, dosing frequency may be reduced to every 4 weeks
Also known as: TALVEY™
Tocilizumab will be administered as a pretreatment medication in advance of administration of the first step-up dose of teclistamab or talquetamab on Cycle 1 Day 1.
Also known as: Actemra
Oral dexamethasone will be administered as a pretreatment medication every 12 hours in 3 doses (PM/AM/PM) following each step-up dose and the first full dose of teclistamab in Cycle 1. A total of 9 doses of oral dexamethasone will be administered.
Also known as: Decadron
Incidence of CRS of any grade during the first two cycles
Evaluate the overall incidence of CRS in the first 2 cycles after a single dose of prophylactic tocilizumab given 2 to 4 hours prior to step-up dose 1 of teclistamab or talquetamab or after 3 doses of oral dexamethasone given after each step-up dose and the first full dose of teclistamab.
Time frame: From first dose of teclistamab or talquetamab, from Day 1 first step-up dose to the end of Cycle 2 (each cycle is 28 days)
Incidence of recurrent CRS of any grade
Evaluate the incidence of recurrent CRS either after a single dose of prophylactic tocilizumab given 2 to 4 hours prior to step-up dose 1 of teclistamab or talquetamab or after 3 doses of oral dexamethasone given after each step-up dose and the first full dose of teclistamab.
Time frame: From first dose of teclistamab or talquetamab, from Day 1 first step-up dose to the end of Cycle 2 (each cycle is 28 days)
Incidence of CRS of any grade
Evaluate the incidence of CRS after a single dose of prophylactic tocilizumab given 2 to 4 hours prior to step-up dose 1 of teclistamab or talquetamab or after 3 doses of oral dexamethasone given after each step-up dose and the first full dose of teclistamab.
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Incidence of recurrent CRS of any grade
Evaluate the incidence of recurrent CRS after a single dose of prophylactic tocilizumab given 2 to 4 hours prior to step-up dose 1 of teclistamab or talquetamab or after 3 doses of oral dexamethasone given after each step-up dose and the first full dose of teclistamab.
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Incidence of Grade ≥2 CRS
Evaluate the incidence of Grade ≥2 CRS based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for CRS (Grade 1 to 5 with grade 5 defined as the worse outcome-Death) in the first 2 cycles after a single dose of prophylactic tocilizumab given 2 to 4 hours prior to step-up dose 1 of teclistamab or talquetamab or after 3 doses of oral dexamethasone given after each step-up dose and the first full dose of teclistamab.
Time frame: From first dose of teclistamab or talquetamab, from Day 1 first step-up dose to the end of Cycle 2 (each cycle is 28 days)
Incidence of Recurrent Grade ≥2 CRS
Evaluate the incidence of Grade ≥2 CRS based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for CRS (Grade 1 to 5 with grade 5 defined as the worse outcome-Death) in the first 2 cycles after a single dose of prophylactic tocilizumab given 2 to 4 hours prior to step-up dose 1 of teclistamab or talquetamab or after 3 doses of oral dexamethasone given after each step-up dose and the first full dose of teclistamab.
Time frame: From first dose of teclistamab or talquetamab, from Day 1 first step-up dose to the end of Cycle 2 (each cycle is 28 days)
Incidence of Grade ≥2 CRS
Evaluate the incidence of Grade ≥2 CRS based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for CRS (Grade 1 to 5 with grade 5 defined as the worse outcome-Death) in the first 2 cycles and throughout the study after a single dose of prophylactic tocilizumab given 2 to 4 hours prior to step-up dose 1 of teclistamab or talquetamab or after 3 doses of oral dexamethasone given after each step-up dose and the first full dose of teclistamab.
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Incidence of Recurrent Grade ≥2 CRS
Evaluate the incidence of Grade ≥2 CRS based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for CRS (Grade 1 to 5 with grade 5 defined as the worse outcome-Death) in the first 2 cycles and throughout the study after a single dose of prophylactic tocilizumab given 2 to 4 hours prior to step-up dose 1 of teclistamab or talquetamab or after 3 doses of oral dexamethasone given after each step-up dose and the first full dose of teclistamab.
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Incidence of Grade ≥3 and any grade infections
Evaluate the risk of Grade ≥3 and any grade infections throughout the study based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 (Grade 1 to 5 with grade 5 representing a worse outcome)
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Incidence of All grade and Grade ≥3 neurotoxicity
Evaluate neurotoxicity in the setting of prophylactic tocilizumab or prophylactic oral dexamethasone based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 (Grade 1 to 5 with grade 5 representing a worse outcome)
Time frame: From first dose of teclistamab or talquetamab, from Day 1 first step-up dose to the end of Cycle 2 (each cycle is 28 days)
Incidence of All grade and Grade ≥3 ICANS
Evaluate neurotoxicity including ICANS in the setting of prophylactic tocilizumab or prophylactic oral dexamethasone based on the American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for ICANS (Grade 1 to 4 with grade 4 representing a worse outcome)
Time frame: From first dose of teclistamab or talquetamab, from Day 1 first step-up dose to the end of Cycle 2 (each cycle is 28 days)
Incidence of All grade neutropenia and Grade ≥3 neutropenia
Evaluate treatment-emergent neutropenia in the setting of teclistamab or talquetamab plus prophylactic tocilizumab or teclistamab plus prophylactic oral dexamethasone based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 (Grade 1 to 5 with grade 5 representing a worse outcome)
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Incidence of all grade febrile neutropenia and Grade ≥3 febrile neutropenia
Evaluate treatment-emergent febrile neutropenia in the setting of teclistamab or talquetamab plus prophylactic tocilizumab or teclistamab plus prophylactic oral dexamethasone based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 (Grade 1 to 5 with grade 5 representing a worse outcome)
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Total length of each hospital stay
Evaluate the length of each hospital stay in the setting of teclistamab or talquetamab plus prophylactic tocilizumab or teclistamab plus prophylactic oral dexamethasone
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Number of hospitalizations per participant
Evaluate the number of hospitalizations per participant, in the setting of teclistamab or talquetamab plus prophylactic tocilizumab or teclistamab plus prophylactic oral dexamethasone
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Healthcare resource utilization in the outpatient setting
Monitor the utilization of healthcare resources in the outpatient setting to mitigate the AEs associated with CRS/ICANS in the setting of teclistamab or talquetamab plus prophylactic tocilizumab or teclistamab plus prophylactic oral dexamethasone
Time frame: From first dose of teclistamab or talquetamab, from Day 1 first step-up dose to the end of Cycle 2 (each cycle is 28 days)
Overall response rate (ORR)
Overall response rate (ORR) will be defined as the proportion of participants who achieve a PR or better response according to the IMWG response criteria
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Time to initial response (TTR)
Time to initial response (TTR) will be defined as the time between the date of the first dose of teclistamab or talquetamab and the first efficacy evaluation that the participants have met all criteria for PR or better response according to the IMWG response criteria
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Time to best response (TTBR)
Time to best response (TTBR) will be defined as the time between the date of the first dose of teclistamab or talquetamab and the first efficacy evaluation that the participants have the best response according to the IMWG response criteria
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Duration of response (DOR)
Duration of response (DOR) will be calculated among responders (with a PR or better response) 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 response criteria
Time frame: Day 1 of every 2 cycles from Cycle 1 Day 1 and up to approximately 12 months of teclistamab treatment or 6 months for talquetamab. (each cycle is 28 days)
Time to next treatment (TTNT)
Time to next treatment (TTNT) is defined as the time from the date of the first dose of teclistamab or talquetamab to the date of next treatment, or death due to any cause, whichever occurs first.
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Overall survival (OS)
Overall survival (OS) is defined as the time from the date of the first dose of teclistamab or talquetamab to the date of death, due to any cause.
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time from the date of the first dose of teclistamab or talquetamab, to the date of first documented disease progression, as defined in the IMWG response criteria, or death due to any cause, whichever occurs first.
Time frame: Day 1 of every 2 cycles From Cycle 1 Day 1 and up to approximately 12 months of teclistamab or 6 months for talquetamab treatment. (each cycle is 28 days)_
Timing of each hospital stay
Evaluate the timing of each hospital stay in the setting of teclistamab or talquetamab plus prophylactic tocilizumab or teclistamab plus prophylactic oral dexamethasone
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Talquetamab Arm only: Number of participants who have had a change in health-related quality of life parameters, from baseline to end of treatment
Talquetamab Arm only: Assess health-related quality of life parameters related to overall health as well as specific impact of taste changes, xerostomia, dysphagia, oral mucositis, and other aspects of oral toxicity using EORTC-QLQ and Epstein taste scale
Time frame: Up to 6 months for talquetamab treatment
Talquetamab Arm only: Number of participants with oral toxicities
Talquetamab Arm only: Assess health-related quality of life parameters related to overall health as well as specific impact of taste changes, xerostomia, dysphagia, oral mucositis, and other aspects of oral toxicity using Epstein taste scale, PRO-CTCAE, STTA and SXI
Time frame: Up to 6 months for talquetamab treatment
Talquetamab Arm only: Number of patients with overall side effects
Talquetamab Arm only: Assess health-related quality of life parameters related to overall health as well as specific impact of taste changes, xerostomia, dysphagia, oral mucositis, and other aspects of oral toxicity using PGI-S and EORTC Q168/EORTC-IL46
Time frame: Up to 6 months for talquetamab treatment
Talquetamab Arm only: Rate of treatment-emergent dysgeusia, oral mucositis, dysphagia, and xerostomia
Talquetamab Arm only: To assess rate of treatment-emergent dysgeusia, oral mucositis, dysphagia, and xerostomia
Time frame: Up to 6 months for talquetamab treatment
Talquetamab Arm only: Time to first onset of treatment-emergent dysgeusia, oral mucositis, dysphagia, and xerostomia
Talquetamab Arm only: To assess time to first onset of treatment-emergent dysgeusia, oral mucositis, dysphagia, and xerostomia
Time frame: Up 6 to months for talquetamab treatment
Talquetamab Arm only: Duration of treatment-emergent dysgeusia, oral mucositis, dysphagia, and xerostomia
Talquetamab Arm only: To assess duration of treatment-emergent dysgeusia, oral mucositis, dysphagia, and xerostomia
Time frame: Up 6 to months for talquetamab treatment
Not enrolling at this site.
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2023 (actual). Primary completion is estimated for Aug 2027, 46 months after the start.
Of 412 non-industry phase 2 interventional studies under Multiple Myeloma, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 96. This study's planned 46 months is below that.
Counting every sponsor, half of 505 studies reached it within 57 months; a quarter within 35 and three quarters within 95.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Teclistamab · Talquetamab · Tocilizumab
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