Selinexor Plus High-Dose Melphalan (HDM) Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma
Phase 1
Completed
- Conditions
- Multiple Myeloma
- Interventions
- Procedure: Autologous Hematopoietic Cell Transplantation (HCT)
- Registration Number
- NCT02780609
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Selinexor Plus HDM HCT Autologous Hematopoietic Cell Transplantation (HCT) 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 Plus HDM HCT Selinexor 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 Plus HDM HCT Melphalan 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 Plus HDM HCT Dexamethasone 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 Plus HDM HCT Fosaprepitant 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.
- Primary Outcome Measures
Name Time Method Complete Response (CR) 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.Phase I: Recommended Phase II Dose (RPh2D) 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States