First line treatment of multiple myeloma
Conditions
Interventions
Product Name: Myrin (Thalidomide)
Product Code: -
Pharmaceutical Form: Tablet
INN or Proposed INN: Thalidomide
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 50-10
Sponsors
Prof. Heinz Ludwig, MD, Wilhelminenspital, First Department of Medicine and Medical Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Patients with multiple myeloma of IgG, IgA, IgD, IgE, IgM (excluding Waldenström‘s macroglobulinaemia), lambda or kappa light chain, low secretory or non-secretory disease. · The diagnosis will be valid if at least two of three Ossermann criteria are met: · M-Gradient · Plasma cell infiltration of bone marrow >10% · Presence of osteolytic bone lesions. · WHO performance status 0,1,2 or 3 · No prior treatment of multiple myeloma. · Clear requirement of treatment. This is usually presumed if patients have Durie/Salmon stage II or III disease. · Anticipated life expectancy of at least 3 months. · Adequate organ function, specifically: · Bone Marrow: WBC ³ 3,000/µl · Platelets ³ 100,000/µl (or below if due to myeloma infiltration) · Hepatic: Bilirubin = 2.0 mg% or 34.2 µmol/l; AST (SGOT), ALT (SGPT) and Alkaline phosphatase =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: · Extramedullary plasmocytoma or solitary plasmocytoma without evidence of dissemination of disease. · Benign monoclonal gammopathy. · Multiple myeloma of IgM without osteolytic bone lesions. · Smouldering myeloma. · More than 3 irradiation fields. · Irreversible performance status of WHO 4 (except paraplegia). · Prior treatment of myeloma with any of the following: chemotherapeutic or immunomodulatory agents, corticosteroids, antiangiogenic agents or other investigational drugs. · Women of childbearing potential · Preexisting peripheral polyneuropathy. · Medical or psychiatric conditions that compromise the patient‘s ability to give informed consent or to complete the study. · Congestive heart failure NYHA III, IV. · Acute infection requiring systemic antibiotics at study entry until resolved. · Any uncontrolled underlying medical condition (eg diabetes, glaucoma). · Second primary malignancy (with the exception of cervical carcinoma in situ and non-melanoma skin malignancies) unless patient has been disease-free for at least five years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the therapeutic efficacy of Thal/Dexamethason to conventional Melphalan/Prednisone in newly diagnosed myeloma patients To compare survival, duriation of maintenance and quality of life in patients receiving interferon alpha plus thalidomide versus single agent interferon alpha ;Secondary Objective: Secondary endpoints: - survival - time to response - toxicity - quality of life;Primary end point(s): Time to progression Response rate | — |
Countries
Hungary
Outcome results
None listed