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

Dexamethasone

Fosaprepitant

Melphalan

Dexamethasone acetate

BB 1101

Aprepitant

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Antineoplastic Agents, Alkylating

Alkylating Agents

Immunosuppressive Agents

Immunologic Factors

Neurokinin-1 Receptor Antagonists

Substance P

Neurokinin A

Neurotransmitter Agents

The conditioning regimen begins 3 days prior to autologous transplant. Day 0 is the day of the autologous hematopoietic cell transplant. Melphalan will be given intravenously (IV) on Day -3 and Day -2; Dexamethasone will be given through via IV on Day -3, Day -2 and Day -1; fosaprepitant at 150 IV on days -3 and -2 will be given to patients an an antiemetic.Selinexor will be taken by mouth (PO) daily on the same day participants receive chemotherapy with melphalan.

Selinexor will be given orally 2 to 3 hours prior to high dose-melphalan IV infusion. Phase I: Dose escalation beginning with 40 mg to determine the recommended Phase II dose (RPh2D). Phase II: Treatment at RPh2D.

Selinexor

Melphalan 100 mg/m\^2 IV over 30-45 minutes.

Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).

Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.

Autologous Hematopoietic Cell Transplantation (HCT)

Fosaprepitant at 150 mg IV on days -3 and -2.

Taiga Nishihori, M.D.

Phase I: The primary purpose of this study phase is to determine the best dose also referred to as the maximum tolerated dose (MTD) of Selinexor when used in combination with high-dose melphalan as a conditioning regimen for hematopoietic cell transplant.

Phase II: The primary purpose of this study phase is to assess the complete response (CR) conversion rate.

Selinexor Plus High-Dose Melphalan (HDM) Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma

Phase 1/2 Investigator Sponsored Study of Selinexor in Combination With High-Dose Melphalan Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma

Progression Free Survival defined as the time from start of treatment to the time of progression or death.

Rate of participants' survival at time of evaluation.

Rate of participants who did not have Minimal Residual Disease (MRD) as assessed by flow cytometry.

RPh2D/Maximum Tolerated Dose (MTD) of Selinexor when used in combination with high-dose melphalan as a conditioning regimen for hematopoietic cell transplant. MTD: the highest dose level at which 1 or less of 6 participants experience a dose limiting toxicity (DLT).

Complete response (CR) conversion rate. CR: Negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and ≤ 5% plasma cells in bone marrow.

tissue plasmacytomas, and ≤ 5% plasma cells in bone marrow.

Complete Response conversion rate. CR: Negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and ≤ 5% plasma cells in bone marrow.

Karyopharm Therapeutics Inc

H. Lee Moffitt Cancer Center and Research Institute

40 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion

Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes.

Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).

Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.

Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.

Phase 1 Level 1: Selinexor Plus HDM HCT

60 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion

Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes.

Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).

Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.

Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.

Phase 1 Level 2: Selinexor Plus HDM HCT

80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion

Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes.

Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).

Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.

Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.

Phase 1 Level 3: Selinexor Plus HDM HCT

Phase 2: Selinexor Plus HDM HCT

40 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1). Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.

Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.

60 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1). Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.

Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.

80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1). Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.

Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Taiga Nishihori, MD

The conditioning regimen begins 3 days prior to autologous transplant. Day 0 is the day of the autologous hematopoietic cell transplant. Melphalan will be given intravenously (IV) on Day -3 and Day -2; Dexamethasone will be given through via IV on Day -3, Day -2 and Day -1; fosaprepitant at 150 IV on days -3 and -2 will be given to patients an an antiemetic.Selinexor will be taken by mouth (PO) daily on the same day participants receive chemotherapy with melphalan.

Selinexor: Selinexor will be given orally 2 to 3 hours prior to high dose-melphalan IV infusion. Phase I: Dose escalation beginning with 40 mg to determine the recommended Phase II dose (RPh2D). Phase II: Treatment at RPh2D.

Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes.

Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).

Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.

Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.

Selinexor Plus HDM HCT

Phase I: Recommended Phase II Dose (RPh2D)

60 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion

Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes.

Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).

80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion

Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes.

Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).

Complete Response (CR)

Phase 1 Dose Level 3 and Phase 2: Selinexor Plus HDM HCT

All evaluable participants treated at dose level 3/RP2D.

Spots Global Cancer Trial Database for Selinexor Plus High-Dose Melphalan (HDM) Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma

Trial Identification

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Interventions

Study Description

Keywords

Eligibility

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