Phase 2
N=22
Selinexor Plus High-Dose Melphalan (HDM) Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma
Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT02780609 ↗Enrolled (actual)
22
Serious AEs
59.1%
Results posted
May 2022
Primary outcome: Primary: Phase I: Recommended Phase II Dose (RPh2D) — 80 mg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Selinexor (Drug); Melphalan (Drug); Dexamethasone (Drug); Autologous Hematopoietic Cell Transplantation (HCT) (Procedure); Fosaprepitant (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase I: Recommended Phase II Dose (RPh2D) |
80 | — |
| PRIMARY Complete Response (CR) |
0; 33.3; 16.6; 10 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02780609). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.