A Phase 2 interventional study of Dexamethasone and Mezigdomide in Multiple Myeloma Refractory and Multiple Myeloma in Relapse, sponsored by PETHEMA Foundation. Not yet recruiting at 20 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by PETHEMA Foundation · Phase 2, Interventional, and Treatment
The goal of this clinical trial is to learn if the drug combination Elranatamab plus Mezigdomide plus Dexametahsone works to cure patients with relapsed/refractory multiple myeloma.
The main questions it aims to answer are:
Do participants receiving Elranatamab plus Mezigdomide plus Dexametahsone achieve optimal treatment response by showing negative minimal residual disease at the end of treatment?
By evaluating the incidence of adverse events and severe adverse events, is this drug combination tolerable for participants?
All participants will receive 1 cycle of Elranatamab plus Dexamethasone followed by 5 cycles of Elranatamab plus Mezigdomide plus Dexamethasone, and 6 cycles of Elranatamab plus Mezigdomide. At this timepoint (end of cycle 12), the level of minimal residual disease will be assessed to decide if patients receive Mezigdomide alone as maintenance (for patients with negative minimal residual disease), or continue reciving Elranatamab plus Mezigdomide.
This is a open-label, phase II clinical trial in which participants with relapsed or refractory multiple myeloma will receive a drug combination of Elranatamab plus Mezigdomide plus Dexametahsone to evaluate the proportion of patients who achieve negative minimal residual disease (defined by the presence of less than 1 tumoral cell out of 100.000 healthy hematopoietic cells). In additon, the tolerability of this drug combination will be assessed by recording the incidence of adverse and severe adverse events.
All participants will receive 1 cycle of Elranatamab plus Dexamethasone followed by 5 cycles of Elranatamab plus Mezigdomide plus Dexamethasone, and 6 cycles of Elranatamab plus Mezigdomide. At this timepoint (end of cycle 12), the level of minimal residual disease will be assessed to decide if patients receive Mezigdomide alone as maintenance (for patients with negative minimal residual disease) until unacceptable toxicity, disease progression, patient withdrawal, loss of follow-up, end of study, or death, whichever occurs first; or continue reciving Elranatamab plus Mezigdomide (for patients with positive minimal residual disease) until unacceptable toxicity, disease progression, patient withdrawal, loss of follow-up, end of study, or death, whichever occurs first.
In those participants receiving Mezigdomide as maintenance therapy from cycle 13 onwards (good responders) who show biological disease progression (according to the International Myeloma Working Group, IMWG) or positivization of minimal resdual disease, Elranatamab will be introduced to the Mezigdomide maintenance therapy.
293 studies on the registry are indexed under Neoplasm, Residual; 137 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 198 interventional studies indexed under Neoplasm, Residual.
Browse Neoplasm, Residual studies →PETHEMA Foundation is the lead sponsor of 107 studies on the registry; 12 are open to participants now.
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.
Patient is, in the investigator's opinion, willing and able to adhere/comply with visit schedule and other protocol requirements.
b. Patient must be able to understand the study procedures. c. Patients aged ≥18 years at the time of signing the form. d. Patients have documented diagnosis of MM according to the IMWG criteria (Lancet Oncol 2014).
e. Patients have a MM who have previously received treatment with at least one line of antimyeloma therapy.
f. Patients must have documented disease progression during or after their last antimyeloma regimen.
g. Patients must have received prior treatment with a lenalidomide-containing regimen and must be intolerant or refractory to it, defined as occurrence of disease progression on lenalidomide or within 60 days after the last dose of treatment to lenalidomide.
h. Patient must have a , defined as follows:
Serum free light-chain (sFLC) levels >100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambdda FLC ratio (for patients whose disease is only measurable by serum FLC) i. Patient must have an (ECOG) performance status score of ≤ 2.
j. All prior relevant treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events (), version 5.0 must be ≤grade 1 at the time of enrolment.
k. Reproductive Status
Male participants must practice true abstinence* (which must be reviewed on a monthly basis) or agree to use a condom during sexual contact with a pregnant individual or an IOCBP while participating in the study, during dose interruptions and for at least 28 days after the last dose of mezigdomide, or for at least 4 months (or 150 days) following last elranatamab dose whichever is longer, even if he has undergone a successful vasectomy.
*True Abstinence is acceptable when this is in line with the preferred and usual lifestyle of the individual. Periodic abstinence (eg, calendar, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
Participants must agree to refrain from donating blood while on study treatment, during dose interruptions, and for at least 28 days following the last dose of Mezigdomide or for 4 months (or 150 days) following last dose of elranatamab, whatever happens later.
Exclusion Criteria:
Patients with non-adequate hematological and/or non-hematological parameters defined as the following laboratory abnormalities:
The following relevant diseases or adverse clinical conditions:
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.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
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.
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 US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
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.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
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.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
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.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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.
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.
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.
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.
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.
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.
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.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
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.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
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.
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.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
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.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (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.
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.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
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.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask 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.
All participants will receive Elranatamab, Mezigdominde and Dexametahsone in 28-day cycles as follows: * Oral Mezigdomide: dose of 0.6 mg daily on days 1 to 21 of each cycle (from cycle 2 onwards). * Oral Dexamethasone: dose of 20 mg/day (≤ 75 years old) or 10 mg/day (\>75 years old) from cycle 1 to 6. * Subcutaneous Elranatamab: Cycle 1: day1 (step-up dose 12 mg), day4 (step-up dose 32 mg), day8 (target dose 76 mg), day15 (76 mg), and day22 (76 mg). Cycles 2 and 3: day1 and day15 (76 mg) of each 28-day cycle. From cycle 4 onwards: day1 (76 mg). From Cycle 13 onwards, participants will discontinue elranatamab and will continue with mezigdomide alone. In those patients who discontinue elranatamab due to sustained MRD negativity, Elranatamab will be reintroduced as from the cycle 2 in case of biological progression (IMWG criteria) or positivization of MRD.
Drug: Dexamethasone · Drug: Mezigdomide · Drug: Elranatamab
All participants will receive Elranatamab, Mezigdominde and Dexametahsone in 28-day cycles as follows: * Oral Mezigdomide: dose of 0.6 mg daily on days 1 to 21 of each cycle (from cycle 2 onwards). * Oral Dexamethasone: dose of 20 mg/day (≤ 75 years old) or 10 mg/day (\>75 years old) from cycle 1 to 6. * Subcutaneous Elranatamab will be given as follows: * Cycle 1: day1 (step-up dose 12 mg), day4 (step-up dose 32 mg), day8 (target dose 76 mg), day15 (76 mg), and day22 (76 mg). * Cycles 2 and 3: day1 and day15 (76 mg) of each 28-day cycle. * From cycle 4 onwards: day1 (76 mg). * From Cycle 13 onwards, patients with positive minimal residual disease will keep receiving Elranatamab as from cycle 4 plus Mezigdomide with above indicated dose.
Drug: Dexamethasone · Drug: Mezigdomide · Drug: Elranatamab
Oral at a dose of 20 mg/day (≤ 75 years old) or 10 mg/day (\>75 years old) weekly from cycle 1 to cycle 6.
Oral at a dose of 0.6 mg daily on days 1 to 21 of the 28-day cycle from C2 onwards (not in C1).
Subcutaneous Elranatamab willl be given as follows: * Cycle 1: day1 (step-up dose 12 mg), day4 (step-up dose 32 mg), day8 (target dose 76 mg), day15 (76 mg), and D22 (76 mg) of a 28-day cycle. * Cycles 2 and 3: day1 and day15 (76 mg) of each 28-day cycle. * From C4 onwards: day1 (76 mg) of each 28-day cycle. * From C13 onwards: those patients who have achieved MRD negativity sustained for at least 3 cycles, will discontinue elranatamab and will continue with mezigdomide alone as maintenance. In those patients who discontinue elranatamab due to sustained MRD negativity, it will be reintroduced as from the cycle 2 in case of biological progression (IMWG criteria) or positivization of MRD.
Proportion of patients achieving minimal residual disease (MRD) negativity.
To evaluate the percentage of participants achieving negative MRD. Negative MRD is defined as the presence of less than 1 tumour cell among 100,000 healthy hematopoietic cells by Next Generation Flow Cytometry in bone marrow, according to the IMWG criteria.
Time frame: 5 years
Proportion of participants showing sustained MRD negativity at 24 months
Percentage of participants showing sustained MRD negativity at 24. Negative MRD is defined as the presence of less than 1 tumour cell among 100,000 healthy hematopoietic cells by Next Generation Flow Cytometry in bone marrow, according to the IMWG criteria.
Time frame: 5 years
Proportion of participants showing MRD negativity after early rescue intervention with elranatamab in patients on mezigdomide alone after C12.
Those participants showing good initial treatment response (allocated in the MRD negative at end cycle 12 intervention arm and receiving Mezigdomide maintenance therapy) who show MRD positivization during maintenance therapy with Mezigdomide alone, will be evaluated to detect the rate of MRD negativization after early rescue intervention with Elranatamab. Negative MRD is defined as the presence of less than 1 tumour cell among 100,000 healthy hematopoietic cells by Next Generation Flow Cytometry in bone marrow, according to the IMWG criteria.
Time frame: 5 years
To evaluate the Complete Response rate to elranatamab in combination with mezigdomide and dexamethasone, based on confirmed response according to the IMWG criteria.
Defined as the percentage of patients who show the following 4 parameters: i) absence of monoclonal protein in serum, ii) absence of monoclonal protein in urine, iii) disappearance of any previous soft tissue plasmacytomas, iv) less than 5% plasma cells in bone marrow aspirates or biopsy
Time frame: 5 years
To evaluate the Very Good Partial Response rate to elranatamab in combination with mezigdomide and dexamethasone, based on confirmed response according to the IMWG criteria.
Defined as having the following conditions: i) \>90% reduction of M protein in serum, ii) less than 100 mg of M protein un urine within 24 hours, iiI) no presence of plasmocitomas.
Time frame: 5 years
To evaluate the Partial Response rate to elranatamab in combination with mezigdomide and dexamethasone, based on confirmed response according to the IMWG criteria.
Defined as havong the following: i) \>50% reduction of serum M protein, ii) \<200mg of M-protein in urine in 24-hour.
Time frame: 5 years
To evaluate the Minimal Response rate to elranatamab in combination with mezigdomide and dexamethasone, based on confirmed response according to the IMWG criteria.
Defined as showing a 25% to 49% reduction in serum monoclonal M-protein alongside a 50% to 89% reduction in 24-hour urinary M-protein.
Time frame: 5 years
To evaluate the Stable Disease rate to elranatamab in combination with mezigdomide and dexamethasone, based on confirmed response according to the IMWG criteria.
Defined as \>25% reduction in serum monoclonal M-protein alongside a \>50% reduction in 24-hour urine M-protein.
Time frame: 5 years
To evaluate the Duration of Response with Elranatamab in combination with mezigdomide and dexamethasone.
Defined as the time from the achievement of at least a Partial Response until the earliest date of documented disease progression by IMWG criteria.
Time frame: 5 years
To evaluate the Progression-free Survival with Elranatamab in combination with mezigdomide and dexamethasone.
Defined as the time from the date of Elranatamab treatment initiation until the earliest date of documented disease progression by IMWG criteria or death due to any cause.
Time frame: 5 years
To evaluate the Overall Survival with Elranatamab in combination with mezigdomide and dexamethasone.
Defined as the time from the date of Elranatamab treatment initiation until the date of death due to any cause.
Time frame: 5 years
Incidence of Adverse Events (AE) related with the treatment with elranatamab in combination with mezigdomide and dexamethasone
Number of adverse events registered within the clinical trial study period related with the treatment with elranatamab in combination with mezigdomide and dexamethasone. Adverse Events are defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure, and are evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Time frame: 5 years
Discontinuation of therapy due to Adverse Event related with the treatment with elranatamab in combination with mezigdomide and dexamethasone
Defined as the percentage of patients discontinuing therapy due to Adverse Events of treatment with elranatamab in combination with mezigdomide and dexamethasone
Time frame: 5 years
Dose modifications due to Adverse Events related with treatment with elranatamab in combination with mezigdomide and dexamethasone
Defined as the percentage of patients requiring dose modifications due to Adverse Events of treatment with elranatamab in combination with mezigdomide and dexamethasone
Time frame: 5 years
Incidence of Severe Adverse Events of treatment with elranatamab in combination with mezigdomide and dexamethasone
Number of severe adverse events, defined as: Any untoward medical occurrence that, at any dose; * Results in death; * Is life threatening; * Requires inpatient hospitalization\* or prolongation of existing hospitalization; * Results in persistent or significant disability/incapacity; * Is a congenital anomaly/birth defect; * Is an important medical event; * Is associated with liver injury and impaired liver function defined as: ALT ≥3 x ULN and total bilirubina ≥2 x ULN (\>35% direct), or ALT ≥3 x ULN and INRb \>1.5. * Any suspected transmission of any infectious agent via a product (medically significant)
Time frame: 5 years
Changes in laboratory analytes from the hematology and blood chemistry panel related to treatment with elranatamab in combination with mezigdomide and dexamethasone
Defined as the number of the changes in laboratory analytes from the hematology and blood chemistry panel related to treatment with elranatamab in combination with mezigdomide and dexamethasone
Time frame: 5 years
Incidence of deaths related with the treatment with elranatamab in combination with mezigdomide and dexamethasone
Defined as the number of deaths related with the treatment with elranatamab in combination with mezigdomide and dexamethasone
Time frame: 5 years
Primary cause of death of treatment with elranatamab in combination with mezigdomide and dexamethasone
Defined as the description of the cause of death related with the treatment with elranatamab in combination with mezigdomide and dexamethasone
Time frame: 5 years
To assess the immune profile induced by elranatamab alone, the triplet combination, and treatment with mezigdomide plus dexamethasone
Immune profiling (qualitative and quantitative study of the composition of B and T leukocytes) performed by Next Generation Flow Cytometry in peripheral blood, during treatment with: * Elranatamab + Dexamethasone * Elranatamab cycles 2 and 3 + Mezigdomide + Dexamethasone * Elranatamab from cycle 4 onwards + mezigdomide + Dexamethasone * Elranatamab from cycle 4 onwards + Mezigdomide * Mezigdomide maintenance
Time frame: 5 years
To assess Progression-free survival according to the quality of the response.
Estimated Progression-free survival according to achievement of MRD negativity (yes/no).
Time frame: 5 years
To assess Overall Survival according to the quality of the response.
Estimated Overall Survival according to achievement of MRD negativity (yes/no).
Time frame: 5 years
Plan to share: No
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Studies of the drugs tested here: Dexamethasone · Mezigdomide · Elranatamab