Selinexor Plus High-Dose Melphalan (HDM) Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma



Status:Recruiting
Conditions:Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/1/2019
Start Date:June 26, 2017
End Date:August 31, 2020

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Phase 1/2 Investigator Sponsored Study of Selinexor in Combination With High-Dose Melphalan Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma

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.


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
We found this trial at
1
site
12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
Principal Investigator: Taiga Nishihori, M.D.
Phone: 813-745-7175
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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from
Tampa, FL
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