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.
Active, not recruiting
Phase 1/Phase 2
| Drug | Synonyms | Arms |
|---|---|---|
| Selinexor | KPT-330 | Selinexor Plus HDM HCT |
| Melphalan | Alkeran | Selinexor Plus HDM HCT |
| Dexamethasone | Decadron | Selinexor Plus HDM HCT |
| Fosaprepitant | antiemetic agent, Standare of Care | Selinexor Plus HDM HCT |
| Name | Type | Description | Interventions |
|---|---|---|---|
| Selinexor Plus HDM HCT | Experimental | 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. |
|
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 |
| 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). |
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | H. Lee Moffitt Cancer Center and Research Institute |
June 18, 2021
