Skip to main content
OpenTrials
Completed

NCT Number: NCT02780609

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Selinexor

Drug

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.

Other names: KPT-330

melphalan

Drug

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

Other names: Alkeran

Dexamethasone

Drug

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

Other names: Decadron

Autologous Hematopoietic Cell Transplantation (HCT)

Procedure

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

Fosaprepitant

Drug

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

Other names: antiemetic agent, Standare of Care

Primary outcomes

  1. Phase I: Recommended Phase II Dose (RPh2D)

    Time frame: Up to 3 months

    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).

  2. Complete Response (CR)

    Time frame: 3 months post HCT

    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.

Other outcomes

  1. Phase 1 and Phase 2 Percentage of Participants Treated at Dose Level 3/RP2D With Progression Free Survival (PFS)

    Time frame: at 24 months

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

  2. Overall Survival (OS)

    Time frame: at 24 months

    Rate of participants' survival at time of evaluation.

  3. Rate of Minimal Residual Disease (MRD)

    Time frame: 3 months post HCT

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

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • Karyopharm Therapeutics Inc

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
May 23, 2016
Registry last updated
Nov 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.