Clinical Trial 18630

Cancer Type: Malignant Hematology
Interventions:Alkeran (Melphalan); Dexamethasone; KPT-330 (Selinexor); Melphalan; Selinexor

Study Type: Treatment
Phase of Study: Phase I/II
Investigators:

  • Taiga Nishihori

Overview

Study Title

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

Summary

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.

Objective

1. The Primary Objective of the phase 1 study is to determine the RPh2D/MTD of conditioning regimen of selinexor plus high-dose melphalan. 2. The Primary Objective of the phase 2 study is to assess complete response (CR) conversion rate at 3 months post HCT. Secondary Objectives: Secondary objectives are to estimate overall response rate (ORR) at 3 months post HCT and to estimate progression-free survival (PFS) and overall survival (OS).

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