ClinicalTrials.gg
TerminatedNCT03256045Updated May 9, 2022Results posted

Panobinostat, Carfilzomib, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

A Phase 2 interventional study of Carfilzomib and Chemosensitivity Assay in Recurrent Plasma Cell Myeloma and Refractory Plasma Cell Myeloma, sponsored by University of Washington. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-09.

Sponsored by University of Washington · Phase 2, Interventional, and Treatment

Why this study was terminated
Terminated due to loss of funding and former PI left the institution
Phase
Phase 2
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 113 studies testing carfilzomib in Multiple Myeloma — 14 open to participants now, 39 under way, 7 of them phase 3. carfilzomib · Multiple Myeloma.

Enrollment
103rd of 113
9 · median 54
Started
2018
with 5 others
Phase 2
50 of 113
6 open now
Registered
66th of 113
by date

Among the 113 studies testing carfilzomib in Multiple Myeloma, this one is the 103rd largest by enrollment, is one of 6 that started in 2018, is one of 50 in phase 2, and was the 66th registered.

Multiple Myeloma

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

Browse Multiple Myeloma studies →

Open to participants now

14 of the 113 studies testing carfilzomib in Multiple Myeloma are open now, in 12 countries. Recruiting first, the newest first:

9 more — sign in →

By country, each count listing its studies:

All 14 open studies →

About carfilzomib

carfilzomib: first FDA approval 2012 (KYPROLIS), first EMA approval 2015. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 584 Multiple Myeloma studies recruiting now, 429 (73%) set no upper age limit and 106 (18%) stop at 75 or younger; 36 take children under 18; 24 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 113 studies testing carfilzomib in Multiple Myeloma, or all of them as a file.
02

Study summary

This phase II trial studies how well panobinostat, carfilzomib, and dexamethasone work in treating patients with multiple myeloma that has come back (relapsed) or does not respond to treatment (refractory). Panobinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, 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. Using multiple myeloma cells from patients' blood samples, the researchers will do laboratory tests to look at how well each of the drugs, alone and in different combinations, kill multiple myeloma cells. If the laboratory tests work well, they may be used in the future to help plan treatment for future patients.

Read the detailed description

PRIMARY OBJECTIVE:

I. To correlate in vitro drug sensitivity testing with clinical response by determining the rate of in vitro drug sensitivity to panobinostat, carfilzomib, and dexamethasone singly and in combination, doublets and triplets.

SECONDARY OBJECTIVE:

I. To monitor response rates (partial response [PR], very good partial response [VGPR], and complete response) using the International Myeloma Working Group Uniform Response Criteria for Multiple Myeloma.

EXPLORATORY OBJECTIVE:

I. Progression free survival and overall survival will be assessed for up to 3 years after last dose.

OUTLINE:

Patients receive panobinostat orally (PO) on days 1, 3, 5, 15, 17, and 19. Patients also receive carfilzomib intravenously (IV) and dexamethasone PO on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and/or bone marrow samples for testing via in vitro chemosensitivity assay.

After completion of study treatment, patients are followed up every 3 months for up to 3 years.

03

Conditions studied

  • Recurrent Plasma Cell Myeloma
  • Refractory Plasma Cell Myeloma

Browse trials for

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

  • Diagnosis of multiple myeloma to or relapsed after >= 1 (International Myeloma Working Group [IMWG] criteria)
  • , as indicated by one of the following:

    • Serum monoclonal (M)-protein >= 1.0 g/dL
    • Elevated involved free light chain >= 10 mg/dL as per IMWG criteria, and abnormal ratio
    • Urine Bence Jones protein > 200 mg/24 hour (hr)
  • (ANC) >= 750/uL
  • count >= 75,000/uL
  • >= 7 g/dL
  • Creatinine =\< 2.0 mg/dL or calculated >= 30 mL/min
  • Total =\< 1.5 x (ULN) unless elevation is thought to be due to Gilbert's syndrome
  • Serum glutamic-oxaloacetic transaminase () (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SPGT) (alanine aminotransferase [ALT]) =\< 2.5 x ULN
  • Patients must avoid consumption of grapefruit, pomegranates, starfruit, Seville oranges or products containing the juice of each during the entire study and preferably 7 days before the first dose of study medications; orange juice is allowed
  • Women of , defined as all women physiologically capable of becoming pregnant, should have a pregnancy test prior to the initiation of treatment and use highly effective methods of during and for 3 months post study treatment; highly effective contraception methods include total abstinence, female sterilization, male sterilization, use of oral, injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy; women using hormonal contraceptives should additionally use a barrier method of contraception; women are considered and not of child-bearing potential if they have had 12 months of natural amenorrhea or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks ago
  • Sexually active males must use a condom during intercourse while taking study drug and for 6 months after stopping treatment; males should not father a child in this period; a condom is required to be used also by vasectomized men as well as during intercourse with a male partner; female partners of sexually active men should also use an effective contraception during treatment and for 6 months after their male partner has stopped taking the drug

Exclusion criteria

Exclusion Criteria:

  • Another bone marrow
  • Another cancer with expected survival of \< 2 years
  • Active viral, bacterial, or fungal infection progressing on current treatment
  • uncontrolled heart disease and/or recent cardiac event within 6 months prior to enrollment, such as:

    • History of angina pectoris, symptomatic pericarditis, or myocardial infarction
    • (LVEF) \< 45% as determined by echocardiogram (ECHO) or multi gated acquisition (MUGA) scan
    • History or presence of any significant, uncontrolled, or persistent cardiac arrhythmias, e.g. ventricular, supraventricular, nodal arrhythmias or conduction abnormality; stable atrial fibrillation within 6 months prior to randomization is permitted
    • Presence of unstable atrial fibrillation (ventricular response rate > 100 beats per minute [bpm]); NOTE: patients with stable atrial fibrillation can be enrolled provided they do not meet other cardiac exclusion criteria
    • Resting heart rate \< 50 bpm
    • Complete left bundle branch block (LBBB), bifascicular block
    • Congenital long syndrome
    • Any clinically significant ST segment and/or T-wave abnormalities
    • Corrected QT (QTcF) > 450 msec for males and > 470 msec for females using Fridericia's correction on screening (ECG)
    • History of documented congestive heart failure ( functional classification III-IV)
    • Uncontrolled hypertension defined by a systolic blood pressure (SBP) >= 150 mmHg and/or diastolic blood pressure (DBP) >= 100 mmHg with or without antihypertensive medication; NOTE: initiation or adjustment of antihypertensive medication(s) is allowed prior to screening
    • Other clinically significant heart disease or vascular disease
  • Currently taking medications that have known or definite risk of prolonging the QT interval or inducing Torsades de pointes (TdP); the medication must be discontinued or switched to a safe alternative medication prior to starting treatment; specific exception is allowed for patients on long-standing medications that have risk of prolonging QT interval or inducing TdP if screening ECG does not indicate a prolonged QT abnormality
  • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of panobinostat or dexamethasone (e.g. ulcerative disease uncontrolled nausea, vomiting, malabsorption syndrome, obstruction, or stomach and/or small bowel resection)
  • Unresolved diarrhea >= (CTCAE) grade 2 or a medical condition associated with chronic diarrhea (such as irritable bowel syndrome, inflammatory bowel disease)
  • Major surgery =\< 14 days prior to starting study treatment or side effects of surgery that have not recovered to \< CTCAE grade 2
Terms in these criteria, in plain language(20)

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

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.

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.

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.

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.

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.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

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.

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.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    Treatment-panobinostat, carfilzomib, dexamethasone,chemo assay

    Patients receive panobinostat PO on days 1, 3, 5, 15, 17, and 19. Patients also receive carfilzomib IV and dexamethasone PO on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and/or bone marrow samples for testing via in vitro chemosensitivity assay.

    Drug: Carfilzomib · Other: Chemosensitivity Assay · Drug: Dexamethasone · Other: Laboratory Biomarker Analysis · Drug: Panobinostat

Interventions

  • Given IV

    Also known as: Kyprolis, PR-171

  • OtherChemosensitivity Assay

    Undergo in vitro chemosensitivity testing

    Also known as: Chemosensitivity Testing

  • Given PO

    Also known as: Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex, Alin, Alin Depot, Alin Oftalmico, Amplidermis, Anemul mono, Auricularum, Auxiloson, Baycuten, Baycuten N, Cortidexason, Cortisumman, Decacort, Decadrol, Decadron, 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, Dexamethasonum, Dexamonozon, Dexapos, Dexinoral, Dexone, Dinormon, Fluorodelta, Fortecortin, Gammacorten, Hexadecadrol, Hexadrol, Lokalison-F, Loverine, Methylfluorprednisolone, Millicorten, Mymethasone, Orgadrone, Spersadex, Visumetazone

  • OtherLaboratory Biomarker Analysis

    Correlative studies

  • Given PO

    Also known as: Faridak, Farydak, LBH589

06

What researchers measure

Primary outcomes

  1. Best Overall Response, by Subject

    Assessed using the International Myeloma Working Group Uniform Response Criteria for Multiple Myeloma. Key: 1 = very good partial response (VGPR); 2 = partial response (PR); 3 = minimal response (MR); 4 = stable disease (SD); 5 = progressive disease (PD). Please see IC50 and CI results in the other primary outcome measures.

    Time frame: 14 months

  2. Multiple Myeloma Cells In-vitro Drug Sensitivity to Panobinostat, by Subject

    Multiple myeloma cells are added to assay with panobinostat. Cell viability and IC50 is determined. IC50 is the inhibitory concentration that kills 50% of cells. Results are reported in concentrations E-9.

    Time frame: At baseline

  3. Multiple Myeloma Cells In-vitro Drug Sensitivity to Carfilzomib, by Subject

    Multiple myeloma cells are added to assay with carfilzomib. Cell viability and IC50 is determined. IC50 is the inhibitory concentration that kills 50% of cells.

    Time frame: At baseline

  4. Multiple Myeloma Cells In-vitro Drug Sensitivity to Dexamethasone, by Subject

    Multiple myeloma cells are added to assay with dexamethasone. Cell viability and IC50 is determined. IC50 is the inhibitory concentration that kills 50% of cells. Results are reported in concentrations E-6.

    Time frame: At baseline

  5. Synergy of Panobinostat and Carfilzomib in Combination, Per Subject.

    Concentration of carfilzomib and panobinostat in combination leading to 90% growth inhibition of multiple myeloma cells in-vitro. The combination index (CI) is calculated using formula: CI = (\[D1\] in the combination / \[D1\] alone) + (\[D2\] in the combination / \[D2\] alone). Key: CI = 1 no synergy; CI\<1 synergy; CI\>1 antagonism.

    Time frame: At baseline

  6. Synergy of Panobinostat and Dexamethasone in Combination, Per Subject

    Concentration of panobinostat and dexamethasone in combination leading to 90% growth inhibition of multiple myeloma cells in-vitro. The combination index (CI) is calculated using formula: CI = (\[D1\] in the combination / \[D1\] alone) + (\[D2\] in the combination / \[D2\] alone). Key: CI = 1 no synergy; CI\<1 synergy; CI\>1 antagonism.

    Time frame: At baseline

07

Results

Posted May 9, 2022
Limitations and caveats
Study was limited by lower accrual than expected due to: competing studies, other investigators' treatment preferences, and ultimately, the departure of the initial PI from the institution. Because of PI's departure and lab closure, the study closed to accrual after the 9th patient enrolled. Because only 9 subjects were enrolled and some in-vitro assay results are unavailable, it is difficult to analyze the in-vitro assay results and determine the parameters that predict disease response.

Participant flow

Participant flow — Overall Study
MilestoneChemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone
Started9
Completed9
Not completed0

Outcome measures

PrimaryBest Overall Response, by Subject

Assessed using the International Myeloma Working Group Uniform Response Criteria for Multiple Myeloma. Key: 1 = very good partial response (VGPR); 2 = partial response (PR); 3 = minimal response (MR); 4 = stable disease (SD); 5 = progressive disease (PD). Please see IC50 and CI results in the other primary outcome measures.

Time frame:
14 months
Reported as:
Number · IMWG Uniform Response Grade
Best Overall Response, by Subject
IMWG Uniform Response GradeChemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone
Subject MM-824
Subject MM-912
Subject MM-922
Subject MM-951
Subject MM-961
Subject MM-981
Subject MM-993
Subject MM-1094
Subject M-1111
PrimaryMultiple Myeloma Cells In-vitro Drug Sensitivity to Panobinostat, by Subject

Multiple myeloma cells are added to assay with panobinostat. Cell viability and IC50 is determined. IC50 is the inhibitory concentration that kills 50% of cells. Results are reported in concentrations E-9.

Time frame:
At baseline
Reported as:
Number · nM
Multiple Myeloma Cells In-vitro Drug Sensitivity to Panobinostat, by Subject
nMChemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone
Subject MM-823.8
Subject MM-915.9
Subject MM-922.6
Subject MM-9519.8
Subject MM-961.3
Subject MM-984.4
Subject MM-998.5
Subject MM-10913.6
Subject MM-1112.0
PrimaryMultiple Myeloma Cells In-vitro Drug Sensitivity to Carfilzomib, by Subject

Multiple myeloma cells are added to assay with carfilzomib. Cell viability and IC50 is determined. IC50 is the inhibitory concentration that kills 50% of cells.

Time frame:
At baseline
Reported as:
Number · nM
Multiple Myeloma Cells In-vitro Drug Sensitivity to Carfilzomib, by Subject
nMChemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone
Subject MM-8217.5
Subject MM-910.479
Subject MM-920.03
Subject MM-950.269
Subject MM-960.0048
Subject MM-980.159
Subject MM-990.159
Subject MM-1090.108
Subject MM-1110.0152
PrimaryMultiple Myeloma Cells In-vitro Drug Sensitivity to Dexamethasone, by Subject

Multiple myeloma cells are added to assay with dexamethasone. Cell viability and IC50 is determined. IC50 is the inhibitory concentration that kills 50% of cells. Results are reported in concentrations E-6.

Time frame:
At baseline
Reported as:
Number · uM
Multiple Myeloma Cells In-vitro Drug Sensitivity to Dexamethasone, by Subject
uMChemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone
Subject MM-823.7
Subject MM-9110.9
Subject MM-957
Subject MM-961.1
Subject MM-9814.8
Subject MM-998.6
Subject MM-10980
Subject MM-1111.1
PrimarySynergy of Panobinostat and Carfilzomib in Combination, Per Subject.

Concentration of carfilzomib and panobinostat in combination leading to 90% growth inhibition of multiple myeloma cells in-vitro. The combination index (CI) is calculated using formula: CI = (\[D1\] in the combination / \[D1\] alone) + (\[D2\] in the combination / \[D2\] alone). Key: CI = 1 no synergy; CI\<1 synergy; CI\>1 antagonism.

Time frame:
At baseline
Reported as:
Number · Combination index
Synergy of Panobinostat and Carfilzomib in Combination, Per Subject.
Combination indexChemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone
Subject MM-912.5
Subject MM-922.4
Subject MM-950.3
Subject MM-962.2
Subject MM-982.6
Subject MM-991.8
Subject MM-1091.7
Subject MM-11162.2
PrimarySynergy of Panobinostat and Dexamethasone in Combination, Per Subject

Concentration of panobinostat and dexamethasone in combination leading to 90% growth inhibition of multiple myeloma cells in-vitro. The combination index (CI) is calculated using formula: CI = (\[D1\] in the combination / \[D1\] alone) + (\[D2\] in the combination / \[D2\] alone). Key: CI = 1 no synergy; CI\<1 synergy; CI\>1 antagonism.

Time frame:
At baseline
Reported as:
Number · CI score
Synergy of Panobinostat and Dexamethasone in Combination, Per Subject
CI scoreChemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone
Subject MM-911.3
Subject MM-922.6
Subject MM-951.4
Subject MM-960.6
Subject MM-981.2
Subject MM-990.9
Subject MM-1094.6
Subject MM-1111.2

Adverse events

Collected over Adverse events after any administration of the study drug through 30 days after the last administration of therapy will be recorded and followed until resolution.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone0/9 (0%)3/9 (33.3%)4/9 (44.4%)
Most frequent serious events
Most frequent serious events
EventChemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone
Non-ST segment elevation myocardial infarctionCardiac disorders1/9
Fracture, pathologicInjury, poisoning and procedural complications1/9
Fracture, non-pathologicInjury, poisoning and procedural complications1/9
FallInjury, poisoning and procedural complications1/9
Most frequent other events
Most frequent other events
EventChemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone
HypertensionVascular disorders2/9
DiarrheaGastrointestinal disorders1/9
SyncopeNervous system disorders1/9

Baseline characteristics

Age, Customized
Age, Customized(years)Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone
Median67 (49 to 72)
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone
Male6
Female3
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone
Hispanic or Latino1
Not Hispanic or Latino8
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White9
More than one race0
Unknown or Not Reported0
Prior therapy regimes
Prior therapy regimes(number of regimens)Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone
Median5 (2 to 9)
Prior autologous transplant
Prior autologous transplant(percentage of participants)Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone
Number88.9
Revised ISS Stage
Revised ISS Stage(ISS Stage)Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone
Median2.5 (1 to 3)
08

Study locations

1 site
  • Fred Hutch/University of Washington Cancer Consortium
    Seattle, Washington 98109, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2018 to primary completion in Feb 2021, 35 months.

Results were first posted in May 2022, 1 year 3 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 16, 2017
First posted
Aug 21, 2017
StartActual
Feb 8, 2018
Primary completionActual
Feb 5, 2021
CompletionActual
Feb 5, 2021
Results first posted
May 9, 2022
Last update
May 9, 2022
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 May 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03256045
Responsible party
Andrew Cowan (Assistant Professor, Division of Medical Oncology, University of Washington) — Principal investigator
First posted
Aug 21, 2017
Start date
Feb 8, 2018
Primary completion
Feb 5, 2021
Completion
Feb 5, 2021
Results posted
May 9, 2022
Last update
May 9, 2022

Study contacts

Andrew Cowan
principal investigator · Fred Hutch/University of Washington Cancer Consortium

Oversight

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

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Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drugs tested here: Carfilzomib · Dexamethasone · Panobinostat

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