Clinical Trials /

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

NCT02780609

Description:

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.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Selinexor Plus High-Dose Melphalan (HDM) Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma
  • Official Title: Phase 1/2 Investigator Sponsored Study of Selinexor in Combination With High-Dose Melphalan Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma

Clinical Trial IDs

  • ORG STUDY ID: MCC-18630
  • NCT ID: NCT02780609

Conditions

  • Multiple Myeloma

Interventions

DrugSynonymsArms
SelinexorKPT-330Selinexor Plus HDM HCT
MelphalanAlkeranSelinexor Plus HDM HCT
DexamethasoneDecadronSelinexor Plus HDM HCT
Fosaprepitantantiemetic agent, Standare of CareSelinexor Plus HDM HCT

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Selinexor Plus HDM HCTExperimentalThe 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
  • Melphalan
  • Dexamethasone
  • Fosaprepitant

Eligibility Criteria

        Inclusion Criteria:

          -  18 years of age or older with histologically confirmed multiple myeloma

          -  Achieving partial response (PR) or very good partial response (VGPR) with systemic
             chemotherapy

          -  Received less than 4 lines of anti-myeloma therapy.

          -  Karnofsky performance status of >= 70%

          -  Adequate pulmonary, cardiac, hepatic and renal function as outlined in the protocol

          -  Signed informed consent form in accordance with institutional policies prior to the
             initiation of high-dose therapy

        Exclusion Criteria:

          -  Non-secretory multiple myeloma

          -  Have achieved complete response (CR) prior to autologous hematopoietic cell
             transplantation (HCT)

          -  Central nervous system (CNS) involvement

          -  Uncontrolled bacterial, viral or fungal infections

          -  Myocardial infarction within 6 months prior to enrollment or has New York Heart
             Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe
             uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute
             ischemia or active conduction system abnormalities.

          -  Prior malignancies within the last 5 years except resected basal cell carcinoma or
             treated cervical carcinoma in situ.

          -  Females who are pregnant or breastfeeding

          -  Have received other investigational drugs within 14 days prior to screening

          -  Prior autologous or allogeneic HCT

          -  Prior organ transplant or autoimmune disease requiring immunosuppressive therapy
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Phase I: Recommended Phase II Dose (RPh2D)
Time Frame:Up to 3 months
Safety Issue:
Description: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).

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:H. Lee Moffitt Cancer Center and Research Institute

Trial Keywords

  • autologous hematopoietic cell transplantation (HCT)
  • high-dose melphalan
  • selinexor

Last Updated

December 30, 2019