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A Multi-Center Phase Ib, Open-Label, Dose-Finding Pilot Study to Evaluate the Combination of Carfilzomib and Cyclophosphamide With Dexamethasone Prior to Autologous Stem Cell Transplant in Patients With Transplant Eligible Newly Diagnosed Multiple Myeloma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

A Multi-Center Phase Ib, Open-Label, Dose-Finding Pilot Study to Evaluate the Combination of Carfilzomib and Cyclophosphamide With Dexamethasone Prior to Autologous Stem Cell Transplant in Patients With Transplant Eligible Newly Diagnosed Multiple Myeloma


Inclusion Criteria:



- Cytopathologically or histologically confirmed diagnosis of MM

- Measurable disease, as indicated by one or more of the following:

- Serum M-protein ≥ 1.0 g/dL

- Urine Bence Jones protein ≥ 200 mg/24 hr

- Elevated Free Light Chain as per the International Myeloma Working Group (IMWG)
criteria

- Males and females ≥ 18 years of age

- Life expectancy of more than 5 months

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2

- Adequate hepatic function, with bilirubin < 2 times the upper limit of normal (ULN),
and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3.5 times
ULN

- Serum Creatinine Clearance(CrCl) ≥ 30 mL/min, either measured or calculated using a
standard formula (e.g. Cockcroft and Gault)

- Additional Laboratory Requirements

- Absolute neutrophil count (ANC) ≥1.0 x 109/L

- Hemoglobin ≥8 g/dL [transfusion permitted]

- Platelet count ≥50.0 x 109/L

- Screening ANC should be independent of granulocyte-and granulocyte/macrophage colony
stimulating factor (G-CSF and GM-CSF) support for at least 1 week and of pegylated
G-CSF for at least 2 weeks

- Patients may receive RBC or platelet transfusions, if clinically indicated, in
accordance with institutional guidelines

- Written informed consent in accordance with federal, local, and institutional
guidelines

- Patients must agree to practice contraception

- Male patients must agree not to donate semen or sperm.

Exclusion Criteria:

- Patients with non-secretory or hyposecretory MM

- Prior treatment for MM (prior radiation therapy or dexamethasone up to 160 mg for
spinal cord compression is allowed. Other limited field radiation involving ≤ 1/3 of
the pelvic area is also allowed)

- Plasma cell leukemia

- Pregnant or lactating females

- Major surgery within 21 days prior to first dose

- Congestive heart failure (CHF) (New York Heart Association class III to IV),
symptomatic ischemia, conduction abnormalities uncontrolled by conventional
intervention or myocardial infarction in the previous six months

- Acute active infection requiring systemic antibiotics, antivirals, or antifungals
within 14 days prior to first dose

- Patients receiving active treatment or intervention for any other malignancy or
patients who, at the Investigator's discretion, may require active treatment or
intervention for any other malignancy within 8 months of starting study treatment.

- Serious psychiatric or medical conditions that could interfere with treatment

- Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of the
first dose and/or within 14 days before study treatment

- Contraindication to any of the required concomitant drugs, including antiviral (e.g.
Valacyclovir) and proton-pump inhibitor (e.g. lansoprazole). Corticosteroid therapy
in a dose equivalent to dexamethasone ≥ 1.5 mg/day or prednisone ≥ 10 mg/day.
(Steroid use is allowed if necessary to treat spinal cord compression and/or
hypocalcaemia.)

- Patients in whom the required program of oral and IV fluid hydration is
contraindicated, e.g. due to pre-existing pulmonary, cardiac, or renal impairment

- Patients with primary systemic amyloidosis.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse Events as a measure of safety and tolerability

Outcome Description:

Review of adverse events for safety and to determine the maximum tolerated dose of the combination treatment.

Outcome Time Frame:

Throughout treatment, estimated to be 4-6 months per patients

Safety Issue:

Yes

Principal Investigator

Jatin Shah, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Academic Myeloma Consortium

Authority:

United States: Food and Drug Administration

Study ID:

AMyC 11-MM-01

NCT ID:

NCT01660750

Start Date:

January 2013

Completion Date:

September 2014

Related Keywords:

  • Multiple Myeloma
  • newly diagnosed multiple myeloma
  • transplant eligible multiple myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Comprehensive Cancer Center at Desert Regional Medical CenterPalm Springs, California  92262
Duke University Medical CenterDurham, North Carolina  27710
University of Pennsylvania Abramson Cancer CenterPhiladelphia, Pennsylvania  19104