E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
First line treatment of multiple myeloma |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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
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E.2.2 | Secondary objectives of the trial |
Secondary endpoints:
- survival - time to response - toxicity - quality of life |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 <3 x upper limit of normal. · Minimum recovery period of 2 weeks following any major surgical procedure before entry into this study. · Women, who are sterilized via hysterectomy or bilateral tubal ligation or at least one year post-menopausal · Age of at least 19 years. There is no upper age limit. · Patients must have been informed and must have signed an informed consent (witness).
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Time to progression Response rate |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 48 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 48 |