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

ConditionMultiple Myeloma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHackensack Meridian Health

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Serum monoclonal protein ≥ 0.5 g/dL

≥200 mg of monoclonal protein in the urine on 24-hour electrophoresis

Serum immunoglobulin free light chain: involved FLC ≥ 10 mg/dL (≥ 100 mg/L) AND abnormal serum immunoglobulin kappa to lambda free light chain ratio

MRD positivity in peripheral blood by flow cytometry.

Disqualifiers

Subject has a history of allergic reactions to compounds containing captisol, or Carfilzomib

Subject has a NYHA Class III or IV heart disease and/or a history of active unstable angina, congestive heart disease, severe uncontrolled cardiac arrhythmia, electrocardiographic evidence of acute ischemia, active conduction system abnormalities or myocardial infarction within 6 months prior to enrollment. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.

Uncontrolled hypertension.

Pulmonary hypertension.

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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).

Treatment groups

18 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Carfilzomib Mobilization - Dose Level 0Experimental treatment 4 interventions
Group B: Carfilzomib Mobilization - Dose Level 1Experimental treatment 4 interventions
Group C: Carfilzomib Mobilization - Dose Level 2Experimental treatment 4 interventions
Group D: Carfilzomib Mobilization - Dose Level 3Experimental treatment 4 interventions
Group E: Carfilzomib Mobilization - Dose Level 4Experimental treatment 4 interventions
Group F: Carfilzomib Mobilization - Dose Level 5Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Safety and tolerability will be assessed by clinical review of all relevant parameters including Adverse Events (CTCAE v4.0)

Time frame
24 Months
2

Maximum tolerated dose (MTD)

To determine the maximum tolerated dose (MTD) of carfilzomib in combination with cyclophosphamide, dexamethasone and G-CSF in mobilizing and collecting peripheral blood stem cells

Time frame
28 Days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hackensack Meridian Health

Lead sponsor

Source ClinicalTrials.gov
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