Carfilzomib Pomalidomide and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

  • STATUS
    Recruiting
  • End date
    Nov 1, 2024
  • participants needed
    101
  • sponsor
    University of Chicago
Updated on 28 January 2021
platelet count
vasectomy
measurable disease
serum proteins
dexamethasone
lenalidomide
neutrophil count
immunoglobulins
electrophoresis
carfilzomib
daratumumab
refractory multiple myeloma
pomalidomide
pomalyst

Summary

The study will investigate the effects of adding carfilzomib to the combination of pomalidomide and dexamethasone in sequential dose escalation cohorts in patients with relapsed or refractory multiple myeloma. This portion of the study is complete.

This study will also investigate the effects of adding daratumumab to the combination of carfilzomib, pomalidomide and dexamethasone.

Description

Patients receive carfilzomib, pomalidomide, and dexamethasone in 28 days treatment cycles. Study treatment continues for as long a their myeloma does not worsen and they do not have unacceptable side effects. After completion of study treatment, patients are followed for up to 2 years.

Details
Condition Multiple Myeloma, Lymphoproliferative Disorder, Lymphoproliferative disorders, multiple myeloma (mm)
Treatment Pomalidomide, Dexamethasone, Daratumumab, Carfilzomib
Clinical Study IdentifierNCT01665794
SponsorUniversity of Chicago
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Relapsed and relapsed/refractory multiple myeloma requiring systemic therapy
Failed at least one prior treatment for multiple myeloma (must have received lenalidomide)
To be enrolled as second line therapy: Must be refractory to lenalidomide (progression on therapy or within 60 days of lenalidomide dosing)
Measurable disease, as indicated by one or more of the following
Serum M-protein >= 0.5 g/dL
Urine M-protein >= 200 mg/24 hours
If serum protein electrophoresis is felt to be unreliable for routine M-protein measurement, then quantitative immunoglobulin levels are acceptable
Involved serum free light chains 10 mg/dL (free light change ratio must be abnormal)
Aged 18 years or older
Life expectancy of more than 3 months
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Adequate Liver Function
Bilirubin < 1.5 times the upper limit of normal (ULN)
Aspartate aminotransferase (AST) < 2.5 times ULN
Alanine aminotransferase (ALT) < 2.5 times ULN
Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
Hemoglobin >= 8 g/dL
Platelet count >= 75 x 10^9/L (should be independent of platelet transfusions for at least 2 weeks)
Calculated or measured creatinine clearance of >= 30 mL/minute
Written informed consent
Negative pregnancy test (for women of childbearing potential) within 10-14 days of starting study treatment and again within 24 hours of first pomalidomide dose
Must agree to practice abstinence or use two acceptable methods of birth control
Men must agree to use latex condom during sexual contact with women of childbearing potential (even if post vasectomy)
Must agree to adhere to all study requirements, visit schedule, outpatient treatment, required concomitant medications, and laboratory monitoring
Must register to mandatory POMALYST REMS program and be willing and able to comply with the requirements of the POMALYST REMS program

Exclusion Criteria

Patients for whom there is the prospect of stem cell transplantation in the next 6 months in the treatment plan are excluded
POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
Plasma cell leukemia
Waldenstrm's macroglobulinemia or immunoglobulin M (IgM) myeloma
Radiotherapy to multiple sites or immunotherapy within 4 weeks before start of protocol treatment (localized radiotherapy to a single site at least 1 week before start is permissible)
Participation in an investigational therapeutic study within 3 weeks or within 5 drug half lives (t1/2) prior to first dose, whichever time is greater
Patients known to be refractory to any proteasome inhibitor other than bortezomib or carfilzomib
Pregnant or lactating
History of allergy to mannitol or prior hypersensitivity to thalidomide, lenalidomide or pomalidomide
Major surgery within 3 weeks prior to first dose
Prior peripheral stem cell transplant within 12 weeks of study enrollment
Has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal (with the exception of hormones for thyroid conditions or estrogen replacement therapy [ERT]), or any investigational therapy within 21 days of enrollment
Myocardial infarction within 6 months prior to enrollment, New York Heart Associate (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
Uncontrolled hypertension or diabetes
Acute active infection requiring systemic antibiotics, antivirals, or anti fungals within two weeks prior to first dose
Known or suspected human immunodeficiency (HIV) infection, known HIV seropositivity
Active hepatitis A, B, or C infection
Non-hematologic malignancy within the past 3 years except adequately treated basal cell, squamous cell skin cancer, thyroid cancer, carcinoma in situ of the cervix or breast, prostate cancer < Gleason grade 6 with stable prostate specific antigen levels or cancer considered cured by surgical resection alone
Any clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
Significant neuropathy (grades 3-4, or grade 2 with pain) at the time of the first dose and/or within 14 days before enrollment
Contraindications to any of the required concomitant drugs, including proton-pump inhibitor (eg, lansoprazole), enteric-coated aspirin, allopurinol or if a history of prior thrombotic disease, warfarin or low molecular weight heparin
Subjects in whom the required program of PO and IV fluid hydration is contraindicated, eg, due to pre-existing pulmonary, cardiac, or renal impairment
Subjects with known or suspected amyloidosis of any organ
Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis
Prior exposure to daratumumab
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