Myeloma MultiplePhase 2ClaSPdNCT04843579

Treatment of Selinexor in Combination With Clarithromycin, Pomalidomide and Dexamethasone for Relapsed Refractory Multiple Myeloma Patients

A Phase 2 study testing Selinexor, Clarithromycin and Pomalidomide in people with Myeloma Multiple and Myeloma, run by Weill Medical College of Cornell University at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 74 years
Conditions the study is for: Myeloma Multiple, Myeloma, Refractory Multiple Myeloma
What is being tested?: Selinexor, Clarithromycin and Pomalidomide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 2 sitesUnited States
Study dates: 29 Dec 2021to 30 Dec 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 74 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Written informed consent in accordance with federal, local, and institutional guidelines.
Age ≥18 and <75 years at the time of informed consent.
Confirmed diagnosis of multiple myeloma
Symptomatic multiple myeloma per IMWG guidelines.
Measurable disease as defined by at least one of the following: a. Serum M-protein ≥ 0.5 g/dL by serum protein electrophoresis (SPEP) or, for IgA myeloma, by quantitative IgA, and/or b. Urinary M-protein excretion at least 200 mg/24 hours, and/or c. Serum FLC ≥ 100 mg/L, provided that FLC ratio is abnormal, and/or d. If serum protein electrophoresis is felt to be unreliable for routine M-protein measurement (e.g., for IgA MM), then quantitative Ig levels by nephelometry or turbidimetry are acceptable.
Relapsed and refractory multiple myeloma with documented evidence of PD after achieving at least SD for ≥ 1 cycle during a previous MM regimen (i.e., relapsed MM), and ≤ 25% response (i.e., patients never achieved ≥ MR) or PD during or within 60 days from the end of the most recent MM regimen (i.e., refractory MM).
Previously received one to four prior lines of therapy and be pomalidomide-naïve.

Who cannot join

Documented active systemic light chain amyloidosis.
Active plasma cell leukemia.
Eastern Cooperative Oncology Group (ECOG) Performance Status greater than 2.
Persistent non-hematological toxicity (except for peripheral neuropathy) from a prior treatment which has not resolved to at least Grade 2 or better by Cycle 1 Day 1 (C1D1).
Severe hepatic dysfunction with either: a. Total bilirubin > 2x ULN (> 3x ULN in subjects with Gilbert's syndrome [hereditary indirect hyperbilirubinemia]), and/or b. AST and/or ALT > 2.5x ULN
Severe renal dysfunction with an estimated creatinine clearance of < 15 mL/min calculated using the Cockcroft and Gault formula.

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Impaired hematopoietic function with either: a. White blood cell count < 1,500/mm3, and/or b. Absolute neutrophil count < 1000/mm3, and/or c. Hemoglobin < 8.0 g/dL, and/or d. Platelet count < 100,000/mm3 (for patients in whom ≥ 50% of bone marrow nucleated cells are plasma cells, platelets ≥ 75,000/mm3 are acceptable).
Blood (or blood product) transfusions or blood growth factors within 7 days of C1D1. Use of hematopoietic growth factor support is acceptable, including erythropoietin (EPO), darbepoetin, granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage colony stimulating factor (GM-CSF), and platelet stimulators (e.g., eltrombopag or romiplostim). However, patients must be platelet transfusion independent for > 1 week in order to be enrolled in the study.
Radiation, chemotherapy or immunotherapy, or any other anticancer therapy within 2 weeks prior to C1D1, or radio-immunotherapy within 6 weeks prior to C1D1. Patients on long-term glucocorticoids during Screening do not require a washout period. Prior radiation is permitted for treatment of fractures or to prevent fractures, as well as for pain management.
Patients with history of spinal cord compression with residual paraplegia.
Treatment with an investigational anti-cancer therapy within 3 weeks prior to C1D1.
Prior autologous stem cell transplantation < 1 month, or allogeneic stem cell transplantation < 3 months prior to C1D1.
Active graft versus host disease after allogeneic stem cell transplantation.
Life expectancy < 3 months.
Major surgery within 4 weeks prior to C1D1.
Active, unstable cardiovascular function with either: a. Symptomatic ischemia, b. Uncontrolled clinically significant conduction abnormalities (e.g., patients with ventricular tachycardia on antiarrhythmics are excluded; patients with 1st degree atrioventricular (AV) block or asymptomatic left anterior fascicular block/right bundle branch block (LAFB/RBBB) will not be excluded), c. Congestive heart failure (CHF) of New York Heart Association (NYHA) Class ≥ 3, d. Myocardial infarction (MI) within 6 months prior to C1D1, or e. Screening 12-lead ECG showing a baseline QT interval as corrected by Bazett's formula (QTc) > 470 msec
Uncontrolled active hypertension
Venous thromboembolism within 6 months prior to C1D1 or a known inherited thrombophilia
Inability to receive either prophylactic or therapeutic anticoagulation as determined appropriate by the Investigator
Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to C1D1
Any active gastrointestinal dysfunction that prevents the patient from swallowing tablets or interferes with absorption of study treatment
Currently pregnant or breastfeeding. Lactating females must agree not to breast feed while receiving selinexor, pomalidomide and/or clarithromycin
A serious psychiatric or medical condition which, in the opinion of the Investigator, could interfere with treatment
Hypersensitivity or contraindication to selinexor, pomalidomide, dexamethasone and/or clarithromycin
Prior exposure to a SINE compound, including selinexor
Concomitant use of any strong CYP3A4 and/or CYP1A2 inhibitors (see Appendix 1)
Unable to obtain commercial clarithromycin, pomalidomide and dexamethasone through a regular and/or specialty pharmacy.
Unable or unwilling to register into the mandatory POMALYST REMSTM program and comply with its requirements.
Male and female patients unwilling or unable to use effective methods of contraception throughout the study and for three months following the last dose. Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal. Note that female patients of childbearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at Screening and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215
Weill Cornell Medicine - Multiple Myeloma Center
New York, New York, 10065

Other trials in United States

About this study

Official title: A Phase 2, Open-Label, Single-Arm Study of Selinexor in Combination With Clarithromycin, Pomalidomide and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma

The purpose of this study is to determine the efficacy and safety of investigational combination therapy of Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd) for patients with relapsed/refractory multiple myeloma. The hypothesis is that the addition of Selinexor to Clarithromycin, Pomalidomide and Dexamethasone will increase the overall response rate of patients with relapsed/refractory multiple myeloma.

Conditions: Myeloma Multiple, Myeloma, Refractory Multiple Myeloma
Being tested: Selinexor, Clarithromycin, Pomalidomide, Dexamethasone
Medical subject headings: Multiple Myeloma, Neoplasms, Plasma Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SelinexorDrug
Given as 60 mg oral capsule
ClarithromycinDrug
Given as 500 mg oral capsule
PomalidomideDrug
Given as 4 mg oral capsule
DexamethasoneDrug
Given as 40 mg oral capsule

Study groups in NCT04843579
Study group	Role	What they receive
Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd)	Experimental	Selinexor • Given orally at a dose of 60 mg on days 1, 8, and 15 of a 28-day cycle. Dexamethasone * Given orally at a dose of 40 mg on days 1, 8, 15 and 22 of a 28-day cycle. * Subjects will receive a prescription for dexamethasone 4 mg tablets (generic). Clarithromycin * Given orally at a dose of 500 mg twice a day on days 1-28 of a 28-day cycle. * Subjects will receive a prescription for clarithromycin 250 or 500 mg tablets (generic) for oral administration. Pomalidomide * Given orally at a dose of 4 mg daily on days 1-21 of a 28-day cycle. * Subjects will receive a 21-day supply of pomalidomide 1, 2, 3, or 4 mg capsules for oral administration for each treatment cycle. Receives: Drug: Selinexor; Drug: Clarithromycin; Drug: Pomalidomide; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Overall Response Rate of Partial Response or Better
ORR is defined as participants who experience a partial response, very good partial response, complete response, or stringent complete response per International Myeloma Working Group Criteria (IMWG) 2016 criteria. Complete Response is defined as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow aspirates. Stringent Complete Response is defined as complete response as noted previously plus normal free light chain ratio and absence of clonal cells in bone marrow biopsy by immune-histochemistry. Partial Response is ≥50% reduction of serum M-protein plus reduction in 24 hour urinary M-protein by ≥90% or to <200 mg per 24 h. Very Good Partial Response is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hr.
Measured: Until disease progression; the maximum time any participant was followed for ORR was 287 days

Secondary outcomes (1)

Number of Participants With Adverse Events
Adverse events will be determined by Events as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The frequency of adverse events will be collected in tabular summary from when a participant consent to study until end of study or patient participant starts a new treatment.
Measured: Adverse events were collected from time of informed consent until 30 days after the last day of study drug administration for each participant. The maximum period that AEs were collected for a participant was 300 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Dec 202130 Dec 2022

First posted13 Apr 2021
Study start29 Dec 2021
Primary completion30 Nov 2022
Study completion30 Dec 2022

Why it stopped: low enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Myeloma MultipleStudies of the same condition, open and under way.
More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04843579
Sponsor's protocol ID: 20-12023093
Acronym: ClaSPd
Status last verified: Oct 2023
First submitted: 10 Apr 2021
Last updated: 25 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
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All Myeloma Multiple trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Open-Label, Single-Arm Study of Selinexor in Combination With Clarithromycin, Pomalidomide and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT04843579
Acronym / sponsor ID: ClaSPd / 20-12023093
Conditions: Myeloma Multiple, Myeloma, Refractory Multiple Myeloma
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: low enrollment
Enrolment: 4 participants (actual)
Lead sponsor: Weill Medical College of Cornell UniversityUniversity, hospital or other
Collaborators: Karyopharm Therapeutics Inc
Study start: 29 Dec 2021 (actual)
Primary completion: 30 Nov 2022 (actual)
Study completion: 30 Dec 2022 (actual)
First posted: 13 Apr 2021 (actual)
Results: Posted 25 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd)	Experimental	Drug: Selinexor, Drug: Clarithromycin, Drug: Pomalidomide, Drug: DexamethasoneSelinexor • Given orally at a dose of 60 mg on days 1, 8, and 15 of a 28-day cycle. Dexamethasone * Given orally at a dose of 40 mg on days 1, 8, 15 and 22 of a 28-day cycle. * Subjects will receive a prescription for dexamethasone 4 mg tablets (generic). Clarithromycin * Given orally at a dose of 500 mg twice a day on days 1-28 of a 28-day cycle. * Subjects will receive a prescription for clarithromycin 250 or 500 mg tablets (generic) for oral administration. Pomalidomide * Given orally at a dose of 4 mg daily on days 1-21 of a 28-day cycle. * Subjects will receive a 21-day supply of pomalidomide 1, 2, 3, or 4 mg capsules for oral administration for each treatment cycle.

Who may qualify

Ages: 18 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Written informed consent in accordance with federal, local, and institutional guidelines.
Age ≥18 and <75 years at the time of informed consent.
Confirmed diagnosis of multiple myeloma
Symptomatic multiple myeloma per IMWG guidelines.
Measurable disease as defined by at least one of the following: a. Serum M-protein ≥ 0.5 g/dL by serum protein electrophoresis (SPEP) or, for IgA myeloma, by quantitative IgA, and/or b. Urinary M-protein excretion at least 200 mg/24 hours, and/or c. Serum FLC ≥ 100 mg/L, provided that FLC ratio is abnormal, and/or d. If serum protein electrophoresis is felt to be unreliable for routine M-protein measurement (e.g., for IgA MM), then quantitative Ig levels by nephelometry or turbidimetry are acceptable.

Key exclusion criteria (29 listed)

Documented active systemic light chain amyloidosis.
Active plasma cell leukemia.
Eastern Cooperative Oncology Group (ECOG) Performance Status greater than 2.
Persistent non-hematological toxicity (except for peripheral neuropathy) from a prior treatment which has not resolved to at least Grade 2 or better by Cycle 1 Day 1 (C1D1).
Severe hepatic dysfunction with either: a. Total bilirubin > 2x ULN (> 3x ULN in subjects with Gilbert's syndrome [hereditary indirect hyperbilirubinemia]), and/or b. AST and/or ALT > 2.5x ULN

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SelinexorGiven as 60 mg oral capsule	Drug	Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd)
ClarithromycinGiven as 500 mg oral capsule	Drug	Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd)
PomalidomideGiven as 4 mg oral capsule	Drug	Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd)
DexamethasoneGiven as 40 mg oral capsule	Drug	Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd)

Primary outcome

Percentage of Participants With Overall Response Rate of Partial Response or Better
Time frame: Until disease progression; the maximum time any participant was followed for ORR was 287 days
ORR is defined as participants who experience a partial response, very good partial response, complete response, or stringent complete response per International Myeloma Working Group Criteria (IMWG) 2016 criteria. Complete Response is defined as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow aspirates. Stringent Complete Response is defined as complete response as noted previously plus normal free light chain ratio and absence of clonal cells in bone marrow biopsy by immune-histochemistry. Partial Response is ≥50% reduction of serum M-protein plus reduction in 24 hour urinary M-protein by ≥90% or to <200 mg per 24 h. Very Good Partial Response is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hr.

1 secondary outcome

Number of Participants With Adverse Events
Time frame: Adverse events were collected from time of informed consent until 30 days after the last day of study drug administration for each participant. The maximum period that AEs were collected for a participant was 300 days.

Results and safety

Results posted to the registry on 25 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd)	4	2

Primary outcome: Percentage of Participants With Overall Response Rate of Partial Response or Better

Time frame: Until disease progression; the maximum time any participant was followed for ORR was 287 days. Count of participants. Unit: Participants

Measure	Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd) n = 4
Value	2

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected from time of informed consent until 30 days after the last day of study drug administration for each participant. The maximum period that AEs were collected for a participant was 300 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd)	1 of 4 (25%)	4 of 4 (100%)	0 of 4

Limitations and caveats (from the sponsor): The statistical analysis plan (and associated statistical power) was based on an expected sample size of 26 participants. As only 4 participants enrolled, this reduced sample size was not sufficient for the statistical analysis plan as written, and, therefore, only descriptive statistics for the response proportions can be presented for the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Myeloma Multiple

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
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Active, not recruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jorge Monge, MD principal investigator

Weill Medical College of Cornell University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Selinexor, Clarithromycin and Pomalidomide in people with Myeloma Multiple and Myeloma, run by Weill Medical College of Cornell University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Overall Response Rate of Partial Response or Better (time frame: Until disease progression; the maximum time any participant was followed for ORR was 287 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04843579.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.