ClinicalTrials.gg
RecruitingNCT04661137Updated Sep 21, 2026

A Study of Selinexor, in Combination With Carfilzomib, Daratumumab or Pomalidomide in Patients With Multiple Myeloma

A Phase 2 interventional study of Selinexor 60 MG and Selinexor 80 MG in Multiple Myeloma, sponsored by Hackensack Meridian Health. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by Hackensack Meridian Health · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2021; still recruiting 5 years 7 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
96
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a prospective, 2-arm (with an additional exploratory arm), open-label, multicenter study looking at the response rate of patients receiving selinexor (KPT-330), in combination with carfilzomib, daratumumab or pomalidomide.

Multiple Myeloma patients with documented disease progression or refractory disease while on current treatment with any carfilzomib-containing regimen (arm 1), any pomalidomide-containing regimen (arm 2) or any daratumumab-containing regimen (exploratory arm) will be included in the study. Patients will be assigned to the respective groups according to their current treatment. If a subject has received more than one of the above therapies, then assignment will be made at their physician's discretion (e.g treatment decision can be made based upon patient and physician preferred tolerance.).

Patients will receive treatment until progressive disease (PD), death, toxicity that cannot be managed by standard of care, or withdrawal, whichever occurs first.

Read the detailed description

This is a Phase 2b, two-arm, open-label, multicenter study of Sd (selinexor 100, 80 or 60 mg) in combination with carfilzomib, or pomalidomide in patients with MM previously treated with carfilzomib or pomalidomide respectively, and refractory to prior treatment. An additional exploratory arm will focus on patients treated with SD in combination with daratumumab.

This study will enroll approximately 96 patients overall (43 in each of the arms and 10 additional patients in the exploratory arm. Patients will be assigned to the respective arms based on their previous treatment.

Patients who are relapsed or refractory to their current carfilzomib-based regimen will be enrolled on Arm 1 and will receive the following treatment regimen on a 28-day cycle:

Carfilzomib 56 mg/m2 on days 1, 8 and 15. They will also receive dexamethasone 40 mg (or 20 mg if patient is ≥ 75 years old) once weekly and Selinexor 80 mg on days 1, 8 and 15.

Patients who are relapsed or refractory to their current pomalidomide-based regimen will be enrolled on Arm 2 and will receive the following treatment regimen on a 28-day cycle:

Pomalidomide 4 mg po daily for 21 days combined with Dexamethasone 40 mg (or 20 mg if patient is ≥ 75 years old) once weekly and Selinexor 60 mg days 1, 8 and 15.

For arms 1 and 2, 13 patients will be accrued in each arm in the first stage. If there are 3 or fewer responses in these 13 patients, the study will be stopped. Otherwise, 30 additional patients will be accrued for a total of 43 (in each arm).

Finally, in the exploratory arm, we will enroll up to 10 patients who are relapsed or refractory to their current daratumumab-based regimen. Patients enrolled on the exploratory arm will receive the following treatment regimen on a 28-day cycle:

Daratumumab on current schedule (16 mg/kg IV days 1,8,15,22 for cycles 1-2; days 1 and 15 for cycles 3-6; day 1 for cycle 7 and on) combined with Dexamethasone 40 mg once weekly (or 20 mg if patient is ≥ 75 years old) and Selinexor 100 mg once weekly.

The Investigator may remove a patient from study treatment using criteria described in Section 10.2. Patients may decide to discontinue study treatment for any reason. Patients who elect to discontinue study treatment should be encouraged to continue in the study so that follow-up information on disease progression, other antineoplastic therapy, symptoms and survival status may be obtained. However, patients may elect to withdraw consent and decline further participation in the trial at any time.

The Investigator must determine the primary reason for a patient's discontinuation of study treatment and record this information on the electronic case report form (eCRF). Patients who are prematurely withdrawn from study treatment are not eligible to re-initiate study treatment on this protocol at a later date.

02

Conditions studied

  • Multiple Myeloma

Browse trials for

Keywords

  • Selinexor
  • KPT-330
03

In context

Multiple Myeloma

3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.

This study's planned enrollment of 96 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Hackensack Meridian Health is the lead sponsor of 113 studies on the registry; 28 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 12 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  1. Age ≥18 years at time of .
  2. confirmed MM and evidence of disease progression while on one of the below MM regimens:

    • Arm 1: to or disease progression while on a carfilzomib-containing regimen
    • Arm 2: Refractory to or disease progression while on a pomalidomide-containing regimen
    • Exploratory Arm: Refractory to or disease progression while on a daratumumab-containing regimen
  3. as defined: Serum M-protein ≥ 0.5 g/dL; urine M-protein excretion at least 200 mg/24h; serum FLC ≥ 100 mg/L, provided that FLC is abnormal; if serum protein electrophoresis is felt to be unreliable for routine M-protein measurement (i.e. IgA MM) then quantitative Ig levels by nephelometry or turbidometry are acceptable; for non-secretory disease, bone marrow plasma cells ≥ 20% or a -proven target lesion by PET/CT or MRI is acceptable
  4. Documented evidence of disease progression (by IMWG criteria) or refractory disease on the current treatment as defined as:

    • Achieving SD or less for ≥ 1 cycle during treatment with regimens stated in #2 (i.e. relapsed) OR
    • \<25% response (i.e. never achieved MR) or PD during or within 60 days from the end-of most recent MM regimen as listed in #2 (i.e. refractory).
  5. Any non-hematological toxicities (except for peripheral neuropathy) that patients experienced from treatments in previous regimens have resolved to Grade 2 or less by Cycle 1 Day 1.
  6. 2 or less
  7. Adequate hepatic function within 28 days prior to C1D1:

    1. Total \< 1.5 × (ULN) (except patients with Gilbert's syndrome who must have a total bilirubin of \< 3 × ULN), and
    2. (AST) and alanine aminotransferase (ALT) normal to \<2 × ULN.
  8. Adequate renal function within 28 days prior to C1D1 as determined by estimated of ≥ 30 mL/min, calculated using the Cockcroft and Gault formula (140 - Age) • Mass (kg)/ (72 • creatinine mg/dL); multiply by 0.85 if female (Cockcroft 1976).
  9. Adequate hematopoietic function within 7 days prior to C1D1: total white blood cell (WBC) count ≥1500/mm3, ≥1000/mm3, ≥8.5 g/dL and count ≥75,000/mm3 (patients for whom \<50% of bone marrow nucleated cells are plasma cells) or ≥50,000/mm3 (patients for whom ≥50% of bone marrow nucleated cells are plasma cells).

    1. Patients receiving hematopoietic growth factor support, including erythropoietin, darbepoetin, granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), and platelet stimulators (eg, eltrombopag, romiplostim, or interleukin-11) must have a 2-week interval between growth factor support and the Screening assessments, but they may receive growth factor support during the study.
    2. Patients must have:

      • At least a 2-week interval from the last red blood cell (RBC) transfusion prior to the Screening hemoglobin assessment, and
      • At least a 1-week interval from the last platelet transfusion prior to the Screening platelet assessment.

    However, patients may receive RBC and/or platelet transfusions as clinically indicated per institutional guidelines during the study.

  10. Female patients of must have a negative serum pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly effective methods of throughout the study and for 3 months following the last dose of study treatment.

Exclusion criteria

Exclusion Criteria:

  • Patients meeting any of the following exclusion criteria are not eligible to enroll in this study:

    1. Smoldering MM
    2. Radiation therapy, chemotherapy or immunotherapy other than above stated regimens in #2 ≤2 weeks prior to C1D1. Patients on long-term glucocorticosteroids during screening do not require a . Prior RT is permitted for treatment of fractures or to prevent fractures as well as for pain management.
    3. Active after stem cell transplant.
    4. \<3 months.
    5. Known active hepatitis A, B, or C infection; or known to be positive for virus ribonucleic acid (RNA) or virus surface antigen.
    6. Has any concurrent medical condition or disease (eg, uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.) that is likely to interfere with study procedures.
    7. Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to Cycle 1 Day 1 (C1D1). Patients on prophylactic antibiotics or with a controlled infection within 1 week prior to C1D1 are acceptable.
    8. Known intolerance, , or to .
    9. Pregnant or breastfeeding females.
    10. Body surface area (BSA) \<1.4 m2 at baseline, calculated by the Dubois (Dubois 1916) or Mosteller (Mosteller 1987) method.
    11. Any active gastrointestinal dysfunction interfering with the patient's ability to swallow tablets, or any active gastrointestinal dysfunction that could interfere with absorption of study treatment.
    12. Inability or unwillingness to take supportive medications such as anti-nausea and anti-anorexia agents as recommended by the National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology (CPGO) (NCCN CPGO) for antiemesis and anorexia/cachexia (palliative care).
    13. Any active, serious psychiatric, medical, or other conditions/situations that, in the opinion of the Investigator, could interfere with treatment, compliance, or the ability to give .
    14. Contraindication to any of the required concomitant drugs or supportive treatments.
    15. Patients unwilling or unable to comply with the protocol
Terms in these criteria, in plain language(24)

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.

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.

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.

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.

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.

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.

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.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
96 participants (estimated)

Study arms

  • Experimental
    Carfilzomib-containing Regimen

    Carfilzomib 56 mg/m2 on days 1, 8 and 15. Dexamethasone 20 mg if ≥ 75 years old and 40 mg if \< 75 years old on days 1, 8, 15 and 22. Selinexor 80 mg on days 1, 8 and 15.

    Drug: Selinexor 80 MG · Drug: Carfilzomib · Drug: Dexamethasone

  • Experimental
    Pomalidomide-containing Regimen

    Pomalidomide 4 mg po daily for 21 days. Dexamethasone 20 mg if ≥ 75 years old and 40 mg if \< 75 years old on days 1, 8, 15 and 22. Selinexor 60 mg on days 1, 8 and 15.

    Drug: Selinexor 60 MG · Drug: Pomalidomide · Drug: Dexamethasone

  • Experimental
    Exploratory/Daratumumab-containing Regimen

    Daratumumab on current schedule (16 mg/kg IV days 1, 8, 15 and 22 for cycles 1-2; days 1 and 15 for cycles 3-6; day 1 for cycle 7 and on). Dexamethasone 20 mg if ≥ 75 years old and 40 mg if \< 75 years old on days 1, 8, 15 and 22. Selinexor 100 mg on days 1, 8, 15 and 22.

    Drug: Selinexor 100 MG · Drug: Daratumumab · Drug: Dexamethasone

Interventions

  • Selinexor 60 mg PO on days 1, 8 and 15

    Also known as: KPT-330

  • Selinexor 80 mg PO on days 1, 8 and 15

    Also known as: KPT-330

  • Selinexor 100 mg PO on days 1, 8, 15 and 22

    Also known as: KPT-330

  • 56 mg/m2 IV on days 1, 8 and 15

    Also known as: Kyprolis

  • 4 mg PO daily for 21 days

    Also known as: Pomalyst

  • 16 mg/kg IV days 1, 8, 15 and 22 for cycles 1-2; days 1 and 15 for cycles 3-6; day 1 for cycle 7 and on

    Also known as: Darzalex

  • 20 mg if ≥ 75 years old and 40 mg if \< 75 years old on days 1, 8, 15 and 22

    Also known as: Dextenza, Ozurdex, Neofordex, others

06

What researchers measure

Primary outcomes

  1. Overall Response Rate (ORR) of patients receiving selinexor with carfilzomib and dexamethasone (Arm 1)

    ORR will include patients who experience partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR), based on International Myeloma Working Group (IMWG) response criteria (Kumar 2016)

    Time frame: 30 Months

  2. Overall Response Rate (ORR) of patients receiving selinexor with pomalidomide and dexamethasone (Arm 2)

    ORR will include patients who experience partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR), based on International Myeloma Working Group (IMWG) response criteria (Kumar 2016)

    Time frame: 30 Months

Secondary outcomes

  1. Progression Free Survival (PFS)

    Duration from start of study treatment to PD or death \[regardless of cause\], whichever comes first

    Time frame: 30 Months

  2. Overall Survival (OS)

    Duration from start of study treatment to death

    Time frame: 30 Months

  3. MRD Negativity

    Rate of achievement of minimal residual disease (MRD) by multiparametric flow cytometry

    Time frame: 30 Months

  4. Incidence of Adverse Events [Safety and Tolerability] using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), v 4.03.

    Incidence of Adverse Events \[Safety and Tolerability\] using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), v 4.03.

    Time frame: 30 Months

  5. Time To Next Treatment (TTNT)

    Duration from start of study treatment to next treament

    Time frame: 30 Months

Other outcomes

  1. Overall Response Rate (ORR) of patients receiving selinexor with daratumumab and dexamethasone

    ORR will include patients who experience partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR), based on International Myeloma Working Group (IMWG) response criteria (Kumar 2016)

    Time frame: 30 Months

  2. Gut Microbiome analysis

    To identify intestinal microbiota associated biomarkers that predict response and risk for development of treatment-related toxicities at baseline, on-treatment, post-treatment and relapse.

    Time frame: 30 Months

  3. Immune cell subset analyses

    Changes from baseline in immune cell subsets in peripheral blood mononuclear and bone marrow mononuclear cells will be monitored.

    Time frame: 30 Months

  4. Analyses of cytokine markers

    Cytokines will be quantified in plasma samples by multiplex ELISA and other readout assays.

    Time frame: 30 Months

  5. Analyses of chemokine markers

    Chemokines will be quantified in plasma samples by multiplex ELISA and other readout assays.

    Time frame: 30 Months

  6. Analyses of inflammatory/anti-inflammatory markers

    Inflammation/anti-inflammation markers will be quantified in plasma samples by multiplex ELISA and other readout assays.

    Time frame: 30 Months

  7. Analyses of bacterial translocation markers

    Bacterial translocation markers will be quantified in plasma samples by multiplex ELISA and other readout assays.

    Time frame: 30 Months

  8. Basic peripheral blood laboratory variables: Lymphocytes

    Basic peripheral blood laboratory value of absolute and relative lymphocytes obtained in routine clinical care will be evaluated prior to treatment, on-treatment, post-treatment, relapse and at development of severe AE (\>3 score).

    Time frame: 30 Months

  9. Basic peripheral blood laboratory variables: Eosinophils

    Basic peripheral blood laboratory value of absolute and relative eosinophils obtained in routine clinical care will be evaluated prior to treatment, on-treatment, post-treatment, relapse and at development of severe AE (\>3 score).

    Time frame: 30 Months

  10. Basic peripheral blood laboratory variables: Monocytes

    Basic peripheral blood laboratory value of absolute and relative monocytes obtained in routine clinical care will be evaluated prior to treatment, on-treatment, post-treatment, relapse and at development of severe AE (\>3 score).

    Time frame: 30 Months

  11. Basic peripheral blood laboratory variables: Neutrophils

    Basic peripheral blood laboratory value of absolute and relative neutrophils obtained in routine clinical care will be evaluated prior to treatment, on-treatment, post-treatment, relapse and at development of severe AE (\>3 score).

    Time frame: 30 Months

  12. Basic peripheral blood laboratory variables: Basophils

    Basic peripheral blood laboratory value of absolute and relative basophils obtained in routine clinical care will be evaluated prior to treatment, on-treatment, post-treatment, relapse and at development of severe AE (\>3 score).

    Time frame: 30 Months

  13. Basic peripheral blood laboratory variables: LDH

    Basic peripheral blood laboratory value of LDH obtained in routine clinical care will be evaluated prior to treatment, on-treatment, post-treatment, relapse and at development of severe AE (\>3 score).

    Time frame: 30 Months

  14. Basic peripheral blood laboratory variables: Neutrophil-to-lymphocyte ratio (NLR)

    Basic peripheral blood laboratory value of absolute neutrophil-to-lymphocyte ratio (NLR) obtained in routine clinical care will be evaluated prior to treatment, on-treatment, post-treatment, relapse and at development of severe AE (\>3 score).

    Time frame: 30 Months

  15. Analyses of genetic profiles

    Exploratory analysis to identify molecular genomic determinants of response or resistance to selinexor in the treatment combinations to define biomarkers

    Time frame: 30 Months

  16. Analyses of markers of de novo or acquired resistance to treatment

    Exploratory analysis to identify mechanisms of de novo or acquired resistance to selinexor in combination with carfilzomib, pomalidomide or daratumumab.

    Time frame: 30 Months

07

Study locations

2 of 2 sites recruiting
08

References and documents

Publications

  • Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16(1):31-41. doi: 10.1159/000180580. PubMed 1244564 ↗
  • Du Bois D, Du Bois EF. A formula to estimate the approximate surface area if height and weight be known. 1916. Nutrition. 1989 Sep-Oct;5(5):303-11; discussion 312-3. No abstract available. PubMed 2520314 ↗
  • Mosteller RD. Simplified calculation of body-surface area. N Engl J Med. 1987 Oct 22;317(17):1098. doi: 10.1056/NEJM198710223171717. No abstract available. PubMed 3657876 ↗
  • Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available. PubMed 7165009 ↗
  • Fridericia L. Die Systolendauer im elektrokardiogramm bei normalen menschen und bei herzkranken. [The duration of systole in the electrocardiogram of normal subjects and of patients with heart disease.]. Acta Medica Scandinavica. 1920;53:469-86.
  • Bahlis N, Chen C, Sebag M et al. A Phase 1B/2 Study of Selinexor in combination with backbone therapies for treatment of relapsed/refractory multiple myeloma. EHA Learning Center. Abstract P277. June 10, 2016.
  • Jakubowiak A, Jasielec J, Rosenbaum CA et al. Final Results of Phase 1 MMRC Trial of Selinexor, Carfilzomib, and Dexamethasone in Relapsed/Refractory MM. Blood 2016. 128;973.
  • Chari A, et al. Results of the Pivotal STORM Study (Part 2) in Penta-Refractory Multiple Myeloma (MM): Deep and Durable Responses with Oral Selinexor Plus low dose Dexamethasone in Patients with Penta-Refractory MM. Blood. 2018. ASH Abstract 598.
  • Gasparetto C, et al. Deep and Durable Respones with Selinexor, Daratumumab and Dexamethasone (SDd) in Patients with MM Previously Exposed to Proteasome Inhibitors and Immunomodulatory Drugs: Results of the Phase 1B Study of SDd. Blood 2018. ASH Abstract 599.
  • Gasparetteo C, Lipe B, Tuchman S, et al. Once weekly selinexor, carfilzomib, and dexamethasone (SKd) in patients with relapsed/refractory multiple myeloma (MM). Poster presented at the 2020 American Society of Clinical Oncology Virtual Annual Meeting. J Clin Oncol 38:2020 (suppl; abstr 8530)
  • Chen CI, Bahlis N, Gasparetto C, et al. Selinexor, pomalidomide, and dexamethasone (SPd) in patients with relapsed or refractory multiple myeloma. Presented at: American Society of Hematology Annual Meeting; Orlando, Florida. December 6-10, 2019.
  • Gasparetto C, Lentzsch S, Schiller GJ et al). Selinexor, daratumumab and dexamethasone in patients with relapsed/refractory multiple myeloma (MM). Poster presented at the 2020 American Society of Oncology Virtual Annual Meeting. J Clin Oncol 38: 2020 (Suppl abstr 8510)

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2021 (actual). Primary completion is estimated for Feb 2028, 83 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 83 months is above 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.

Registered
Dec 3, 2020
First posted
Dec 10, 2020
StartActual
Mar 16, 2021
Primary completionEst.
Feb 2028
CompletionEst.
Feb 2028
Last update
Sep 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04661137
Responsible party
Sponsor
First posted
Dec 10, 2020
Start date
Mar 16, 2021
Primary completion
Feb 2028 (estimated)
Completion
Feb 2028 (estimated)
Last update
Sep 21, 2026

Study contacts

Palka Anand
Contact
Palka.Anand@hmhn.org
551-996-3040
Kristin Ivanovski
Contact
Kristin.Ivanovski@hmhn.org
551-996-5231
Noa Biran, MD
principal investigator · Hackensack Meridian Health

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Selinexor · Carfilzomib · Pomalidomide · Daratumumab

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