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

H. Lee Moffitt Cancer Center and Research Institute logo

H. Lee Moffitt Cancer Center and Research Institute

Status and phase

Completed
Phase 2
Phase 1

Conditions

Multiple Myeloma

Treatments

Drug: Fosaprepitant
Drug: Selinexor
Drug: Dexamethasone
Procedure: Autologous Hematopoietic Cell Transplantation (HCT)
Drug: Melphalan

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02780609
MCC-18630

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Sequential Assignment

Masking

None (Open label)

22 participants in 1 patient group

Selinexor Plus HDM HCT
Experimental group
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.
Treatment:
Drug: Dexamethasone
Drug: Melphalan
Drug: Selinexor
Procedure: Autologous Hematopoietic Cell Transplantation (HCT)
Drug: Fosaprepitant

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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