Multiple Myeloma Clinical Trial

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

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.

View Eligibility Criteria

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

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

22

Study ID:

NCT02780609

Recruitment Status:

Completed

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

H. Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

22

Study ID:

NCT02780609

Recruitment Status:

Completed

Sponsor:


H. Lee Moffitt Cancer Center and Research Institute

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.