Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Anti-Infective Agents

Dexamethasone

Pomalidomide

Dexamethasone acetate

Clarithromycin

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Anti-Bacterial Agents

Enzyme Inhibitors

Cytochrome P-450 CYP3A Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

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.

Selinexor

Jorge Monge, MD

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.

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

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

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.

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.

Karyopharm Therapeutics Inc

Weill Medical College of Cornell University

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.

Selinexor: Given as 60 mg oral capsule

Clarithromycin: Given as 500 mg oral capsule

Pomalidomide: Given as 4 mg oral capsule

Dexamethasone: Given as 40 mg oral capsule

Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd)

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

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.

Multiple Myeloma Program Manager

Percentage of Participants With Overall Response Rate of Partial Response or Better

Number of Participants With Adverse Events

Overall Study

Spots Global Cancer Trial Database for Treatment of Selinexor in Combination With Clarithromycin, Pomalidomide and Dexamethasone for Relapsed Refractory Multiple Myeloma Patients

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial