Study of Pomalidomide, Cyclophosphamide, Dexamethasone in Relapsed/Refractory Multiple Myeloma

Description

This study is being done to learn more about the drug, pomalidomide and to gather data on its safety and side effects when used in combination with commercially available cyclophosphamide and dexamethasone. This combination is considered experimental and has not been approved by the FDA. Pomalidomide is a third generation immunomodulatory (IMiDs) agent, which is a more potent version of thalidomide and lenalidomide drugs that have been approved by the United States Food and Drug Administration [FDA] for the treatment of MM. In February 2013, pomalidomide was also approved by the FDA for patients with MM who have had more than 2 types of therapy. Pomalidomide is taken orally as capsules, and cyclophosphamide and dexamethasone are also taken orally as tablets in this study. Cyclophosphamide and dexamethasone are commercially available and are often used in combination with other drugs to treat Multiple Myeloma. Preliminary data from both the laboratory and patient studies suggest that this combination of drugs is more effective than pomalidomide and dexamethasone alone. However, the regimen being used in this study, which consists of daily cyclophosphamide, also permits support of low blood counts with either injections or transfusions as needed.

Study Start Date

June 2014

Estimated Completion Date

December 2016

Interventions

  • Drug: Pomalidomide
  • Drug: Cyclophosphamide
  • Drug: Dexamethasone

Specialties

  • Oncology: Myeloproliferative Dz,Pharmacology/Therapy
  • Pharmacy: Chemotherapy/Oncology
  • Physician Assistant: Clinical Pharmacology,Hematology/Oncology

MeSH Terms

  • Cyclophosphamide
  • Dexamethasone
  • Multiple Myeloma
  • Plasma Cell

Study ID

Mount Sinai School of Medicine -- GCO 14-0825

Status

Unknown

Trial ID

NCT02176213

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

35

Sponsor

Mount Sinai School of Medicine

Inclusion Criteria

    Disease related:
  • Patients must have a history of symptomatic multiple myeloma according to the IMWG criteria
  • Patients must have received at least two prior lines of therapy and also must be refractory to lenalidomide.
  • Patient has relapsed or relapsed/refractory MM.
  • Patients must currently have measurable disease, as defined as: 1. Serum M-protein ? 0.5 g/dL 2. Urine M-protein ? 200 mg/24 hours 3. Serum free light chain assay: involved FLC level ? 10 mg/dl provided serum FLC ratio is abnormal 4. If no monoclonal protein is detected, then > 30% monoclonal bone marrow plasma cells Demographic:
  • Male or female adults ? 18 years old
  • Able to sign informed consent and to comply with the protocol
  • Life expectancy > 12 weeks
  • ECOG performance status ? 2
  • All study participants must be registered into the mandatory POMALYST REMS program, and be willing and able to comply with the requirements of the POMALYST REMS program. Laboratory
  • ANC ? 1000/µL
  • Platelets ? 50,000/µL (Patients with plasma cells 50% of bone marrow nucleated cells, and platelets ? 30,000/µL will be permitted regardless of the baseline ANC)
  • Cr < 3
  • AST ? 2.5 x ULN
  • ALT ? 2.5 x ULN
  • Serum Bilirubin ? 1.5 x ULN Other
  • Females of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 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 at least 28 days before taking pomalidomide.

Exclusion Criteria

  • Previous treatment with pomalidomide
  • Patients who received chemotherapy or radiation therapy to 30% of marrow-bearing bone within ? 2 weeks or experimental agent/therapy within 4 weeks prior to starting study treatment
  • or who have not yet recovered from side effects of such therapies
  • Known hypersensitivity to thalidomide or lenalidomide
  • The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide, lenalidomide or similar drugs
  • Other concurrent severe and/or uncontrolled medical conditions including abnormal laboratory values that could cause unacceptable safety risks or compromise compliance with the protocol
  • Patients for whom prophylactic anticoagulation therapy is not an option unless due to thrombocytopenia
  • Patients who received allogenic stem cell transplantation < 12 months prior to entering the study or show evidence of active graft-versus-host disease that requires immunosuppressive therapy
  • Patients with existing peripheral neuropathy grade > 2
  • Patients with an active malignancy requiring treatment in the next 12 months
  • Patients with known positivity for HIV or active hepatitis B or C
  • Corticosteroid therapies of > 20 mg/day prednisone, > 4 mg/day dexamethasone, > 80 mg/day hydrocortisone, or equivalent.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Icahn School of Medicine at Mount Sinai - New York, New York 46.8 miles None None None

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