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

Doxorubicin

Liposomal doxorubicin

Dexamethasone acetate

BB 1101

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Combination Therapy: Phase I Dose Escalation followed by Phase 2 treatment at Recommended Phase 2 Dose (RP2D).

After the initial screening visit and registration in the study, participants will receive Selinexor orally at a dose of 80 mg along with dexamethasone for 1 day. One week later, patients will receive weekly selinexor at a starting dose from 60 mg once a week to 80 mg twice a week in combination with pegylated liposomal doxorubicin at a starting dose of 20 mg/m², and dexamethasone 40 mg orally weekly.

Selinexor orally as outlined in the study treatment arm.

Selinexor

Pegylated liposomal doxorubicin at a starting dose of 20 mb/m² as outlined in the treatment arm.

Participants will be instructed to take Dexamethasone 40 mg (10 tablets) orally once weekly with meals (ideally with breakfast to minimize insomnia). Participants older than 75 years and patients previously intolerant to 40 mg dosage will be allowed to receive 20 mg (5 tablets) once a week.

Rachid Baz, M.D.

The main purpose of this study is to determine the recommended doses of selinexor in combination with liposomal doxorubicin and dexamethasone for patients with relapsed and refractory myeloma. In addition, the study will assess whether this combination with effective for patients with multiple myeloma.

Selinexor (KPT-330) and Liposomal Doxorubicin For Relapsed and Refractory Multiple Myeloma

Investigator-Initiated Phase I/II Clinical Trial of Selinexor (KPT-330) and Liposomal Doxorubicin for Relapsed and Refractory Multiple Myeloma

Determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D): Selinexor on Days 1, 8 and 15 when given in combination with Lipodox 20 mg/m\^2 and Dexamethasone 40 mg.

Dose level 1: 40 mg in combination with Lipodox and Dexamethasone.

Dose level 2: 80 mg (D1,8,15) in combination with Lipodox and Dexamethasone.

Dose level 2m: 80 mg (D1,8,15) in combination with Lipodox and Dexamethasone.

Dose level 3m: 80 mg (D1,3,8,10) in combination with Lipodox and Dexamethasone.

ORR per the modified uniform response criteria of the International Myeloma Working Group (IMWG), partial response and better. Partial Remission (PR): \>/= 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by \>/= 90% or to \< 200 mg per 24 hours; Very Good Partial Remission (VGPR): Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hours; Complete Remission (CR): Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \</= 5% plasma cells in bone marrow. Stable Disease: Not meeting criteria for CR, VGPR, PR, or progressive disease. Minimal response: Less than 50% decrease in M protein. Not evaluable: Cannot be measured because enough information has not been collected.

Determine the overall response rate per the modified uniform response criteria of the International Myeloma Working Group (IMWG), partial response and better. Partial Remission (PR): \>/= 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by \>/= 90% or to \< 200 mg per 24 hours; Very Good Partial Remission (VGPR): Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hours; Complete Remission (CR): Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \</= 5% plasma cells in bone marrow.

Karyopharm Therapeutics Inc

H. Lee Moffitt Cancer Center and Research Institute

All Adverse Events (AEs) and Serious Adverse Events (SAEs) at all grade levels, regardless of causality have been reported in this section. One participant died prior to treatment but after consent. Only participants who received treatment were considered at Risk for Serious and Other Adverse Events.

Dose 1: Participants were administered Lipodox 20 mg/m\^2 via IV on Day 1 of cycle. Selinexor at 40 mg was given orally on days 1,8 and 15 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15.

Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 1

Dose 2: Participants were administered Lipodox 20 mg/m\^2 on Day 1 of cycle. Selinexor at 80 mg was given orally on days 1,8 and 15 of the cycle.

Dexamethasone at 40 mg was given orally on days 1, 8 and 15.

Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 2

Dose 1m: Participants were administered Lipodox 20 mg/m\^2 on Day 1 of cycle. Selinexor at 60 mg was given orally on days 1,8 and 15 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15.

Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 1m

Dose 2m: Participants were administered Lipodox 20mg/m\^2 on Day 1 of cycle. Selinexor at 80 mg was given orally on days 1,8 and 15 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15.

Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 2m

Dose 3m: Participants were administered Lipodox 20mg/m\^2 on Day 1 of cycle. Selinexor at 80 mg was given orally on days 1,3, 8 and 10 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15.

Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 3m

Phase 2 Dose: Participants were administered Lipodox 20 mg/m\^2 on Day 1 of cycle. Selinexor at 80 mg was given orally on days 1,8 and 15 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15.

Selinexor, Liposomal Doxorubicin and Dexamethasone- RP2D

Combination Therapy: Phase I Dose Escalation followed by Phase 2 treatment at Recommended Phase 2 Dose (RP2D)

Selinexor, Liposomal Doxorubicin and Dexamethasone

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Rachid Baz

All participants treated during dose escalation

Maximum Tolerated Dose (MTD)

>/= Very Good Partial Response

>/= Partial Response

>/= Minimal Response

Stable Disease

Not Evaluable

Overall Response Rate (ORR) - All Participants

All participants treated at recommended phase 2 dose, regardless of when they joined the study.

Overall Response Rate (ORR) -All Participants Treated at Recommended Phase 2 Dose

Dose 2: Participants were administered Lipodox 20 mg/m\^2 on Day 1 of cycle. Selinexor at 80 mg was given orally on days 1,8 and 15 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15.

Spots Global Cancer Trial Database for Selinexor (KPT-330) and Liposomal Doxorubicin For Relapsed and Refractory Multiple Myeloma

Trial Identification

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Interventions

Study Description

Keywords

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