E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028228 |
E.1.2 | Term | Multiple myeloma |
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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 study the efficacy of low dose Lenalidomide maintenance treatment following non myeloablative Allo-SCT on Event Free Survival |
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E.2.2 | Secondary objectives of the trial |
-To study the efficacy of low dose Lenalidomide maintenance treatment following non myeloablative Allo-SCT on Overall Survival -To determine the safety of low dose Lenalidomide maintenance treatment following non myeloablative Allo-SCT including evaluation of GvHD and CTC grade toxicity (Appendix F and C) -To analyse relevant immunomodulating effects of lenalidomide in Multiple Myeloma in vivo. -To evaluate the response rate of low dose Lenalidomide maintenance treatment for patients not in CR before start treatment with lenalidomide.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age 18-66 years; - Patients with, before start (V)AD, a confirmed diagnosis of multiple myeloma stage II or III according to the Salmon & Durie criteria (see appendix A), included in or treated according to the HOVON 65/GMMG-HD4 study; - Patient has received 3 cycles of (V)AD induction therapy with or without Bortezomib, CAD and 1 cycle of high dose Melphalan with autologous stem cell reinfusion; - Patient has received a NMA allogeneic transplantation between 2 and 6 months after autologous stem cell reinfusion according to the criteria described in paragraph 8.2; - The allogeneic transplantation has been administered between 28 and 90 days ago. - WHO performance status 0-2 (see appendix D); -Laboratory test results within these ranges: * Absolute neutrophil count ≥ 1.0 x 109/L *Platelet count ≥75 x 109/L * Serum creatinine cleareance ≥ 50 ml/min *Total bilirubin <= 30 μmol/l *AST (SGOT) and ALT (SGPT) <= 3 x Upper Limit of Normal (ULN) - Negative pregnancy test before inclusion if female of child baring potential - Sexually active woman of child bearing potential must agree to use 2 adequate contraceptive methods while on study drug (and 4 weeks before and after study drug) (for detailed information see section 9.2.2). - Men must agree not to father a child and agrees to use a condom if his partner is of childbearing potential. - Disease free of prior malignancies for ≥5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma “insitu” of the cervix or breast - Written informed consent, preferably signed in the presence of both patient and investigator and signed on the same date.
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E.4 | Principal exclusion criteria |
- Acute Graft versus host Disease ≥ grade 2 (at time of registration); - Pregnant or lactating females. - Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. - Use of any other experimental drug or therapy within 28 days of baseline. - Known hypersensitivity to thalidomide. - The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs. - Any prior use of lenalidomide. - Concurrent use of other anti-cancer agents or treatments. - All subjects Patients with brain disease with the exception of those subjectspatients whose brain disease has been treated with either radiotherapy or surgery and remains asymptomatic, with no active brain disease, as shown by CT scan or MRI, for at least 6 months. - Severe cardiac dysfunction (NYHA classification II-IV, see appendix E) - Known positive for HIV or infectious hepatitis, type B or C
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E.5 End points |
E.5.1 | Primary end point(s) |
Progression Free Survival of lenalidomide maintenance following non myeloablative Allo-SCT. |
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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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
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) | Information not present in EudraCT |
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.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |