A Phase 1 interventional study of Biospecimen Collection and Bone Marrow Aspiration and Biopsy in Plasmacytoma, Recurrent Multiple Myeloma and Refractory Multiple Myeloma, sponsored by National Cancer Institute (NCI). Terminated at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-10.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment
This phase I trial studies the side effects and best dose of MDM2 Inhibitor KRT-232 when given together with carfilzomib, lenalidomide, and dexamethasone in treating patient with multiple myeloma that has come back (relapsed) or has not responded to previous treatment (refractory). KRT-232 (AMG 232) may stop the growth of cancer cells by blocking a protein called MDM2 that is needed for cell growth. Lenalidomide help shrink or slow the growth of multiple myeloma. Drugs used in chemotherapy, such as carfilzomib and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving MDM2 Inhibitor KRT-232, lenalidomide, carfilzomib, and dexamethasone together may work better in treating patients with multiple myeloma.
PRIMARY OBJECTIVES:
I. Evaluate safety and tolerability of MDM2 Inhibitor KRT-232 (KRT-232 [AMG 232]) in combination with carfilzomib, lenalidomide, and dexamethasone (KRd). (Part A) II. Determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of KRT-232 (AMG 232) in combination with carfilzomib, lenalidomide, and dexamethasone (KRd). (Part A) III. Confirm the safety and tolerability of KRT-232 (AMG 232) in combination with carfilzomib, lenalidomide, and dexamethasone (KRd) at MTD/tentative RP2D in a goal of 10 subjects with relapsed and/or refractory myeloma. (Part B)
SECONDARY OBJECTIVES:
I. Evaluate pharmacodynamic (PD) effects of KRT-232 (AMG 232) through serum MIC-1 levels. (Part A) II. Assess KRT-232 (AMG 232) exposure-response relationships (PD, toxicity, and efficacy). (Part A) III. Evaluate the overall response rate of KRT-232 (AMG 232) in combination with carfilzomib, lenalidomide, and dexamethasone (KRd) in relapsed/refractory myeloma by International Myeloma Working Group (IMWG) criteria. (Part B) IV. Evaluate PD effects of KRT-232 (AMG 232) through serum MIC-1 levels. (Part B) V. Assess KRT-232 (AMG 232) exposure-response relationships (PD, toxicity, and efficacy). (Part B)
EXPLORATORY OBJECTIVES:
I. To observe and record anti-tumor activity of KRT-232 (AMG 232) in combination with carfilzomib, lenalidomide, and dexamethasone (KRd) in relapsed/refractory myeloma by International Myeloma Working Group (IMWG) criteria. (Part A) II. Evaluate ribonucleic acid (RNA) expression levels of relevant genes in the TP53 pathway that may predict response to therapy using pre- and post-treatment bone marrow biopsies. (Parts A and B)
OUTLINE: This is a dose-escalation study of MDM2 Inhibitor KRT-232.
Patients receive MDM2 Inhibitor KRT-232 orally (PO) once daily (QD) on days 1-7, carfilzomib intravenously (IV) over 10-30 minutes on days 1-2, 8-9, and 15-16 of cycles 1-12 and on days 1-2 and 15-16 of cycles 13-18, lenalidomide PO on days 1-21, and dexamethasone PO or dexamethasone sodium phosphate IV on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unexpected toxicity. Patients undergo echocardiography during screening and bone marrow biopsy and aspiration, and blood sample collection throughout the study.
After completion of study treatment, patients are followed up for 30 days.
34 studies on the registry are indexed under Plasmacytoma; 6 are open to participants now.
This study's enrollment of 35 is above the median of 22 across 29 interventional studies indexed under Plasmacytoma.
Browse Plasmacytoma studies →National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) 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.
Subjects must have , as defined by at least one of the following:
Subjects must have disease that has after their most recent therapy, with progressive disease (PD) being defined as an increase of 25% from the lowest response value in any one or more of the following:
Subjects must have completed their most recent drug therapy directed at multiple myeloma in the following timeframes:
Exclusion Criteria:
(HIV)-positive subjects positive for human immunodeficiency virus (HIV) are NOT excluded from this study, but HIV-positive subjects must have:
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.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
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.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
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.
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.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
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.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
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).
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 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.
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.
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.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
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.
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.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
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.
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.
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.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
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.
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.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
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.
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.
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.
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.
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.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
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.
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.
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.
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.
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.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
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.
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.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
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.
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.
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.
Patients receive MDM2 Inhibitor KRT-232 PO QD on days 1-7, carfilzomib IV over 10-30 minutes on days 1-2, 8-9, and 15-16 of cycles 1-12 and on days 1-2 and 15-16 of cycles 13-18, lenalidomide PO on days 1-21, and dexamethasone PO or dexamethasone sodium phosphate IV on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unexpected toxicity. Patients undergo echocardiography during screening and bone marrow biopsy and aspiration, and blood sample collection throughout the study.
Procedure: Biospecimen Collection · Procedure: Bone Marrow Aspiration and Biopsy · Drug: Carfilzomib · Drug: Dexamethasone · Drug: Dexamethasone Sodium Phosphate · Procedure: Echocardiography · Drug: Lenalidomide · Drug: Navtemadlin
Undergo blood sample collection
Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo bone marrow aspiration and biopsy
Given IV
Also known as: Carfilnat, CFZ, Kyprolis, PR 171, PR-171, PR171
Given PO
Also known as: Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex, Alin, Alin Depot, Alin Oftalmico, Amplidermis, Anemul mono, Auricularum, Auxiloson, Baycadron, Baycuten, Baycuten N, Cortidexason, Cortisumman, Decacort, Decadrol, Decadron, Decadron DP, Decalix, Decameth, Decasone R.p., Dectancyl, Dekacort, Deltafluorene, Deronil, Desamethasone, Desameton, Dexa-Mamallet, Dexa-Rhinosan, Dexa-Scheroson, Dexa-sine, Dexacortal, Dexacortin, Dexafarma, Dexafluorene, Dexalocal, Dexamecortin, Dexameth, Dexamethasone Intensol, Dexamethasonum, Dexamonozon, Dexapos, Dexinoral, Dexone, Dinormon, Dxevo, Fluorodelta, Fortecortin, Gammacorten, Hemady, Hexadecadrol, Hexadrol, LenaDex, Lokalison-F, Loverine, Methylfluorprednisolone, Millicorten, Mymethasone, Orgadrone, Spersadex, TaperDex, Visumetazone, ZoDex
Given IV
Also known as: Cebedex, Corson, Dalalone, Decaject, Dekasol LA, Dexacen, Dexamethasone Sodium Phosphates, Dexasone, Dezone, ReadySharp Dexamethasone, Soludecadron, Solurex, Topidex
Undergo echocardiography
Also known as: EC
Given PO
Also known as: CC 5013, CC-5013, CC5013, CDC 501, Revlimid
Given PO
Also known as: (3R,5R,6S)-5-(3-Chlorophenyl)-6-(4-chlorophenyl)-3-methyl-1-((1S)-2-methyl-1-(((1-methylethyl)sulfonyl)methyl)propyl)-2-oxo-3-piperidineacetic Acid, AMG 232, AMG-232, KRT 232, KRT-232, KRT232, MDM2 Inhibitor KRT-232
Evaluate Safety and Tolerability of KRT-232 (AMG 232) in Combination With Carfilzomib, Lenalidomdie, and Dexamethasone (KRd)
Time frame: at least 6 months of treatment, an average of 1 year
Determine Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of KRT-232 (AMG 232) in Combination With Carfilzomib, Lenalidomdie, and Dexamethasone (KRd)
Time frame: at least 6 months of treatment, an average of 1 year
Evaluate PD Effects of KRT-232 (AMG 232) Through Serum MIC-1 Levels.
Time frame: 30 days after last dose
Assess KRT-232 (AMG 232) Exposure-response Relationships (PD, Toxicity, and Efficacy).
Time frame: 30 days after last dose
Study opened to accrual on 10/2017 at 6 sites across ETCTN network (MD Anderson, UC Davis, UT San Antonio, UT Austin, University of Utah, Weill Cornell). Study closed to accrual 07/2024 due to uncertain development plan of MDM2 inhibitors in myeloma and slow accrual after discussion with NCI CTEP leadership and study industry collaborator, Kartos Therapeutics.
| Milestone | Part A (Dose-escalation) 60mg | Part A (Dose-escalation) 90mg | Part A (Dose-escalation) 120mg | Part A (Dose-escalation) 190mg | Part A (Dose-escalation) 240mg | Part B (Dose-expansion) |
|---|---|---|---|---|---|---|
| Started | 6 | 0 | 0 | 0 | 0 | 0 |
| Completed | 3 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 3 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Adverse event | 2 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Alternative treatment | 1 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Part A (Dose-escalation) 60mg | Part A (Dose-escalation) 90mg | Part A (Dose-escalation) 120mg | Part A (Dose-escalation) 190mg | Part A (Dose-escalation) 240mg | Part B (Dose-expansion) |
|---|---|---|---|---|---|---|
| Started | 0 | 10 | 0 | 0 | 0 | 0 |
| Completed | 0 | 3 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 7 | 0 | 0 | 0 | 0 |
| Withdrew: Death | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Physician decision | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 2 | 0 | 0 | 0 | 0 |
| Withdrew: Alternative treatment | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Tp53 mutation or indeterminate tp53 mutation status | 0 | 2 | 0 | 0 | 0 | 0 |
| Milestone | Part A (Dose-escalation) 60mg | Part A (Dose-escalation) 90mg | Part A (Dose-escalation) 120mg | Part A (Dose-escalation) 190mg | Part A (Dose-escalation) 240mg | Part B (Dose-expansion) |
|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Part A (Dose-escalation) 60mg | Part A (Dose-escalation) 90mg | Part A (Dose-escalation) 120mg | Part A (Dose-escalation) 190mg | Part A (Dose-escalation) 240mg | Part B (Dose-expansion) |
|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Part A (Dose-escalation) 60mg | Part A (Dose-escalation) 90mg | Part A (Dose-escalation) 120mg | Part A (Dose-escalation) 190mg | Part A (Dose-escalation) 240mg | Part B (Dose-expansion) |
|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Dose Limiting Toxicity | Part A: Dose Level 1 | Part A: Dose Level 2 |
|---|---|---|
| Evaluate Safety and Tolerability of KRT-232 (AMG 232) in Combination With Carfilzomib, Lenalidomdie, and Dexamethasone (KRd) | 1 | 1 |
| mg | Part A: Dose Level 1 | Part A: Dose Level 2 |
|---|---|---|
| Determine Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of KRT-232 (AMG 232) in Combination With Carfilzomib, Lenalidomdie, and Dexamethasone (KRd) | NA | NA |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Collected over At least 6 months of treatment, an average of 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part A (Dose-escalation) 60 mg | 0/6 (0%) | 2/6 (33.3%) | 6/6 (100%) |
| Part A (Dose-escalation) 90 mg | 1/10 (10%) | 7/10 (70%) | 10/10 (100%) |
| Part A (Dose-escalation) 120 mg | — | — | — |
| Part A (Dose-escalation) 190 mg | — | — | — |
| Part A (Dose-escalation) 240 mg | — | — | — |
| Event | Part A (Dose-escalation) 60 mg | Part A (Dose-escalation) 90 mg | Part A (Dose-escalation) 120 mg | Part A (Dose-escalation) 190 mg | Part A (Dose-escalation) 240 mg |
|---|---|---|---|---|---|
| Lung infectionInfections and infestations | 2/6 | 0/10 | — | — | — |
| Febrile neutropeniaBlood and lymphatic system disorders | 1/6 | 2/10 | — | — | — |
| Eye disorders - Other, specify - Vision DecreasedEye disorders | 1/6 | 0/10 | — | — | — |
| Eye painEye disorders | 1/6 | 0/10 | — | — | — |
| PancreatitisGastrointestinal disorders | 1/6 | 0/10 | — | — | — |
| Urinary tract infectionInfections and infestations | 1/6 | 0/10 | — | — | — |
| White blood cell decreasedBlood and lymphatic system disorders | 1/6 | 0/10 | — | — | — |
| Infections & infestations - Other - Covid-19 InfectionInfections and infestations | 0/6 | 1/10 | — | — | — |
| Platelet count decreasedBlood and lymphatic system disorders | 0/6 | 1/10 | — | — | — |
| StrokeNervous system disorders | 0/6 | 1/10 | — | — | — |
| Event | Part A (Dose-escalation) 60 mg | Part A (Dose-escalation) 90 mg | Part A (Dose-escalation) 120 mg | Part A (Dose-escalation) 190 mg | Part A (Dose-escalation) 240 mg |
|---|---|---|---|---|---|
| White blood cell decreasedInvestigations | 6/6 | 6/10 | — | — | — |
| Platelet count decreasedInvestigations | 6/6 | 4/10 | — | — | — |
| Neutrophil count decreasedInvestigations | 6/6 | 3/10 | — | — | — |
| Lymphocyte count decreasedInvestigations | 5/6 | 6/10 | — | — | — |
| AnemiaBlood and lymphatic system disorders | 5/6 | 4/10 | — | — | — |
| HyperglycemiaMetabolism and nutrition disorders | 5/6 | 4/10 | — | — | — |
| HypokalemiaMetabolism and nutrition disorders | 4/6 | 3/10 | — | — | — |
| HyponatremiaMetabolism and nutrition disorders | 4/6 | 3/10 | — | — | — |
| HypophosphatemiaMetabolism and nutrition disorders | 4/6 | 3/10 | — | — | — |
| DiarrheaGastrointestinal disorders | 3/6 | 6/10 | — | — | — |
Relapsed and/or refractory TP53 WT Multiple Myeloma subjects with 1-3 lines of prior therapy.
| Age, Categorical(Participants) | Part A (Dose-escalation) 60 mg | Part A (Dose-escalation) 90 mg | Part A (Dose-escalation) 120 mg | Part A (Dose-escalation) 190 mg | Part A (Dose-escalation) 240 mg | Total |
|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | — | — | — | 0 |
| Between 18 and 65 years | 3 | 6 | — | — | — | 9 |
| >=65 years | 3 | 4 | — | — | — | 7 |
| Sex: Female, Male(Participants) | Part A (Dose-escalation) 60 mg | Part A (Dose-escalation) 90 mg | Part A (Dose-escalation) 120 mg | Part A (Dose-escalation) 190 mg | Part A (Dose-escalation) 240 mg | Total |
|---|---|---|---|---|---|---|
| Female | 3 | 4 | — | — | — | 7 |
| Male | 3 | 6 | — | — | — | 9 |
| Ethnicity (NIH/OMB)(Participants) | Part A (Dose-escalation) 60 mg | Part A (Dose-escalation) 90 mg | Part A (Dose-escalation) 120 mg | Part A (Dose-escalation) 190 mg | Part A (Dose-escalation) 240 mg | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 3 | 2 | — | — | — | 5 |
| Not Hispanic or Latino | 3 | 8 | — | — | — | 11 |
| Unknown or Not Reported | 0 | 0 | — | — | — | 0 |
| Race (NIH/OMB)(Participants) | Part A (Dose-escalation) 60 mg | Part A (Dose-escalation) 90 mg | Part A (Dose-escalation) 120 mg | Part A (Dose-escalation) 190 mg | Part A (Dose-escalation) 240 mg | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | — | — | — | 0 |
| Asian | 0 | 1 | — | — | — | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | — | — | — | 0 |
| Black or African American | 0 | 2 | — | — | — | 2 |
| White | 4 | 6 | — | — | — | 10 |
| More than one race | 0 | 0 | — | — | — | 0 |
| Unknown or Not Reported | 2 | 1 | — | — | — | 3 |
| Region of Enrollment(participants) | Part A (Dose-escalation) 60 mg | Part A (Dose-escalation) 90 mg | Part A (Dose-escalation) 120 mg | Part A (Dose-escalation) 190 mg | Part A (Dose-escalation) 240 mg | Total |
|---|---|---|---|---|---|---|
| United States | 6 | 10 | — | — | — | 16 |
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Studies of the drug tested here: Navtemadlin
National Cancer Institute (NCI) →