E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relapsed or refractory multiple myeloma |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess activity of Cetuximab in patients with refractory/relapsed multiple myeloma |
|
E.2.2 | Secondary objectives of the trial |
Safety profile of Cetuximab +/- Dexamethasone Freedom from treatment failure Progression-free survival Overall survival Pharmacogenomic evaluation of response to treatment |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Multiple myeloma diagnosed according to the Durie-criteria in stage II or III (Salmon and Durie) Measurable disease Refractory or relapsed disease after at least one line of treatment Male or female >= 18 years of age Life expectancy > 12 weeks ECOG performance status 0-2 If of childbearing potential, willingness to use effective contraceptive method for the study duration and 6 months post-dosing No surgery, radiotherapy or chemotherapy or any investigational agent within 4 weeks of study entry Signed written informed consent |
|
E.4 | Principal exclusion criteria |
Asecretory multiple myeloma Patients eligible and willing to undergo high dose chemotherapy followed by autologous stem cell transplantation Prior allogeneic transplantation Prior antibody or EGFR-pathway targeting therapy Severe cardiovascular disease like functionally restricting heart rhythm disturbance or heart malformation or severe hypertension, or cardiac insufficiency > NYHA-II HIV Infection, Hepatitis B or C Brain disorders, psychatric illness Insufficient bone marrow reserve (Leucocytes < 1500/µl; Thromocytes < 50000/µl) Creatinine-Clearance < 30 ml/min or serum creatinine > 3.0 mg/dl A FEV1 < 50% of the reference value Bilirubin > 2 mg/dl; ASAT, ALAT > 100 U/l Pregnancy (absence confirmed by serum/urine b-HCG) or breast-feeding Pulmonary dysfunction Active secondary malignancy Legal incapacity or limited legal capacity Having participated in another clinical trial or any investigational agent in the preceding 30 days Known allergic/hypersensitivity reaction to any compounds of the treatment Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent Known drug abuse/alcohol abuse |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Overall response rate (complete response + partial response + minimal response) |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
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
|
The end of study is defined as the end of study visit of the last patient. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 4 |