Selinexor (KPT-330) and Liposomal Doxorubicin For Relapsed and Refractory Multiple Myeloma

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT02186834
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Selinexor — DRUG
    Selinexor orally as outlined in the study treatment arm.
  • Liposomal doxorubicin — DRUG
    Pegylated liposomal doxorubicin at a starting dose of 20 mb/m² as outlined in the treatment arm.
  • Dexamethasone — DRUG
    Participants will be instructed to take Dexamethasone 40 mg (10 tablets) orally once weekly with meals (ideally with breakfast to minimize insomnia). Participants older than 75 years and patients previously intolerant to 40 mg dosage will be allowed to receive 20 mg (5 tablets) once a week.

Study Details

The main purpose of this study is to determine the recommended doses of selinexor in combination with liposomal doxorubicin and dexamethasone for patients with relapsed and refractory myeloma. In addition, the study will assess whether this combination with effective for patients with multiple myeloma.

Key Dates

Start date
Sep 23, 2014
Status verified
Dec 2022
Primary completion
Nov 8, 2017
Completion
Mar 14, 2018

Study Design

Enrollment
28 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Selinexor, Liposomal Doxorubicin and Dexamethasone
    Combination Therapy: Phase I Dose Escalation followed by Phase 2 treatment at Recommended Phase 2 Dose (RP2D). After the initial screening visit and registration in the study, participants will receive Selinexor orally at a dose of 80 mg along with dexamethasone for 1 day. One week later, patients will receive weekly selinexor at a starting dose from 60 mg once a week to 80 mg twice a week in combination with pegylated liposomal doxorubicin at a starting dose of 20 mg/m², and dexamethasone 40 mg orally weekly.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: Up to 12 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201-

Find similar trials in Tampa, FL

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
H. Lee Moffitt Cancer Center and Research Institute· Tampa, FLBarbara Ann Karmanos Cancer Institute· Detroit, MI

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