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A Multi-Center Phase I/II, Open-Label, Dose-Finding Pilot Study of the Combination of Carfilzomib and Pomalidomide With Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

A Multi-Center Phase I/II, Open-Label, Dose-Finding Pilot Study of the Combination of Carfilzomib and Pomalidomide With Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma


Inclusion Criteria:



- Cytopathologically or histologically confirmed diagnosis of multiple myeloma

- Relapsed or refractory to the most recently received therapy. Refractory disease is
defined as ≤ 25% response or progression during therapy or within 60 days after
completion.

- All patients must have received prior lenalidomide therapy and been determined to be
refractory. Refractory will be defined as ≤ 25% response or progression during
therapy or within 60 days after completion of a regimen containing full or maximally
tolerated dose of lenalidomide administered for at least two completed cycles of
therapy.

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

Serum M-protein ≥ 0.5 g/dL Urine Bence Jones protein ≥ 200 mg/24 hr Elevated Free Light
Chain as per IMWG criteria, and abnormal ratio

- Males and females ≥ 18 years of age

- Life expectancy of more than 3 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 times ULN

- Uric acid must be within laboratory normal range

- Creatinine Clearance ≥ 50 mL/min

- 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 red blood cell (RBC) or platelet transfusions, if clinically
indicated, in accordance with institutional guidelines

- Screening platelet count should be independent of platelet transfusions for at least
2 weeks.

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

- Females of childbearing potential (FCBP)must agree to ongoing pregnancy testing

- FCBP must have a negative serum or urine pregnancy test with a sensitivity of at
least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting
pomalidomide and must either commit to continued abstinence from heterosexual
intercourse or begin TWO acceptable methods of birth control, one highly effective
method and one additional effective method AT THE SAME TIME, beginning 2 weeks prior
to initiating treatment with pomalidomide, during treatment, during treatment delay,
and continuing for 4 weeks following discontinuation of pomalidomide therapy. If a
hormonal method or IUD is not medically possible for the patient, the patient may use
another highly effective method or two barrier methods at the same time.

- Male patients must agree to never have unprotected sexual contact with a female who
can become pregnant and must agree to either completely abstain from sexual contact
with females who are pregnant or are able to become pregnant, or he must use a latex
condom every time he engages in sexual contact with females who are pregnant or may
become pregnant while he is taking pomalidomide and for 4 weeks after he stops taking
the drug, even if he has had a successful vasectomy. The patient must agree to
inform his physician if he has had unprotected sexual contact with a female who can
become pregnant or if he thinks for any reason that his sexual partner may be
pregnant.

- Male patients cannot donate semen or sperm while taking pomalidomide and for 28 days
after completing the study.

- All patients must be counseled at a minimum of every 28 days about pregnancy
precautions and risks of fetal exposure.

- Patients must agree to take enteric-coated aspirin 81 mg orally daily, or if history
of prior thrombotic disease, must be fully anticoagulated with warfarin (INR 2-3) or
be treated with full-dose, low molecular weight heparin, as if to treat deep venous
thrombosis (DVT)/pulmonary embolism (PE)at the investigator's discretion

Exclusion Criteria:

- Patients with known sensitivity to any immunomodulatory drugs (IMiDs)

- • Use of any other experimental drug or therapy within 21 days prior to first dose

- Exposure to any prior chemotherapy, steroid use, or other myeloma treatment within 14
days prior to first dose. Patients currently on long term steroids do not require
any washout period. in addition, steroid use for spinal cord compression is
permitted and does not require a washout period.

- Radiation therapy within 14 days prior to first dose

- Known allergies to carfilzomib or Captisol

- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and
skin changes)

- Plasma cell leukemia

- Waldenström's macroglobulinemia

- Major surgery within 21 days prior to first dose

- Pregnant or lactating females

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

- Uncontrolled hypertension

- 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 enrollment

- Contraindication to any of the required concomitant drugs, including proton-pump
inhibitor (e.g. lansoprazole), enteric-coated aspirin or if a history of prior
thrombotic disease, warfarin or low molecular weight heparin

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

- Patients with primary systemic amyloidosis

- Patients who have received prior treatment with carfilzomib (Phase II only)

- Patients who have received prior treatment with pomalidomide (Phase II only)

Type of Study:

Interventional

Study Design:

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 at 2-12 months per patient

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 10-MM-01

NCT ID:

NCT01464034

Start Date:

November 2011

Completion Date:

October 2015

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Columbia UniversityNew York, New York  10032-3784
Duke University Medical CenterDurham, North Carolina  27710
University of Pennsylvania Abramson Cancer CenterPhiladelphia, Pennsylvania  19104
Indiana University Simon Cancer CenterIndianapolis, Indiana  46202