Clinical trial · Interventional
Selinexor Plus High-Dose Melphalan (HDM) Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma
Phase 1/2 Investigator Sponsored Study of Selinexor in Combination With High-Dose Melphalan Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous Hematopoietic Cell Transplantation (HCT) | Procedure | — | UNRESOLVED |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Fosaprepitant | Drug | — | UNRESOLVED |
| Melphalan | Drug | Melphalan | ALIAS |
| Selinexor | Drug | Selinexor | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Selinexor Plus HDM HCT
- description
- 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.
- interventionNames
- Drug: Selinexor
- Drug: Melphalan
- Drug: Dexamethasone
- Procedure: Autologous Hematopoietic Cell Transplantation (HCT)
- Drug: Fosaprepitant
Primary outcomes (2)
- measure
- Phase I: Recommended Phase II Dose (RPh2D)
- timeFrame
- Up to 3 months
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDTurner JG, Cui Y, Bauer AA, Dawson JL, Gomez JA, Kim J, Cubitt CL, Nishihori T, Dalton WS, Sullivan DM. Melphalan and Exportin 1 Inhibitors Exert Synergistic Antitumor Effects in Preclinical Models of Human Multiple Myeloma. Cancer Res. 2020 Dec 1;80(23):5344-5354. doi: 10.1158/0008-5472.CAN-19-0677. Epub 2020 Oct 6. PMID 33023948