Overview

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