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

• Status: Active, not recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: Karyopharm Therapeutics Inc; Karyopharm Therapeutics, Inc
• Treatments: Antiemetics; Aprepitant; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Fosaprepitant; Melphalan

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