Carfilzomib Based Chemotherapy Mobilization for Autologous Stem Cell Transplants in Multiple Myeloma

Part of paid clinical trials in Hackensack, New Jersey.

Sponsor
Hackensack Meridian Health
Study ID
NCT03909412
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Carfilzomib — DRUG
    Carfilzomib will be administered over 10 minutes for the 20 mg/m2 and 27 mg/m2 dose and over 30 minutes for all higher doses.
  • Cyclophosphamide — DRUG
    Cyclophosphamide dosed at 2gm/m2 administered over 1 hour.
  • Dexamethasone — DRUG
    Dexamethasone 40mg IV/PO to be administered as a premedication.
  • Granulocyte Colony-Stimulating Factor — DRUG
    On day 7 subjects will initiate high dose G-CSF injections at 14mcg/kg daily (with a cap of 1440mcg daily).

Study Details

This phase I study utilizes a 3+3 design with escalating cohorts of Carfilzomib at 20mg/m2, 27mg/m2, 36mg/m2, 45mg/m2, 56mg/m2, and 70mg/m2 to be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone and Granulocyte colony-stimulating factor (G-CSF)

Key Dates

Start date
Oct 8, 2019
Status verified
Feb 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Carfilzomib Mobilization - Dose Level 0
    Carfilzomib at 20mg/m2 over 10 minutes will be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone 40mg and G-CSF. For patients who are naïve to carfilzomib based therapy a priming dose of Carfilzomib (20mg/m2) will be administered 1 week prior to the cohort dosing.
  • Experimental: Carfilzomib Mobilization - Dose Level 1
    Carfilzomib at 27mg/m2 over 10 minutes will be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone 40mg and G-CSF. For patients who are naïve to carfilzomib based therapy a priming dose of Carfilzomib (20mg/m2) will be administered 1 week prior to the cohort dosing.
  • Experimental: Carfilzomib Mobilization - Dose Level 2
    Carfilzomib at 36mg/m2 over 30 minutes will be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone 40mg and G-CSF. For patients who are naïve to carfilzomib based therapy a priming dose of Carfilzomib (20mg/m2) will be administered 1 week prior to the cohort dosing.
  • Experimental: Carfilzomib Mobilization - Dose Level 3
    Carfilzomib at 45mg/m2 over 30 minutes will be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone 40mg and G-CSF. For patients who are naïve to carfilzomib based therapy a priming dose of Carfilzomib (20mg/m2) will be administered 1 week prior to the cohort dosing.
  • Experimental: Carfilzomib Mobilization - Dose Level 4
    Carfilzomib at 56mg/m2 over 30 minutes will be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone 40mg and G-CSF. For patients who are naïve to carfilzomib based therapy a priming dose of Carfilzomib (20mg/m2) will be administered 1 week prior to the cohort dosing.
  • Experimental: Carfilzomib Mobilization - Dose Level 5
    Carfilzomib at 70mg/m2 over 30 minutes will be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone 40mg and G-CSF. For patients who are naïve to carfilzomib based therapy a priming dose of Carfilzomib (20mg/m2) will be administered 1 week prior to the cohort dosing.

Primary Outcome Measure

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 24 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hackensack Meridian Health - John Theurer Cancer CenterHackensackNew Jersey07601
Mariefel Vendivil
[email protected]
551-996-5828
Geneva Khan
[email protected]
551-996-3923
David Vesole, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Hackensack, NJ

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Hackensack Meridian Health - John Theurer Cancer Center· Hackensack, NJ

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