E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Survival of multiple myeloma patients following autologous transplant in study AMD3100-3102. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
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 | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The objective of this long-term observational study is to assess progression-free survival and overall survival of patients treated with at least 1 dose of study treatment (placebo or plerixafor) for a period of 5 years following the first dose of study treatment (placebo or plerixafor) in protocol AMD3100-3102. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All patients who received at least 1 dose of study treatment (placebo or plerixafor) in protocol AMD3100-3102. |
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E.4 | Principal exclusion criteria |
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E.5 End points |
E.5.1 | Primary end point(s) |
Progression-free survival and overall survival will be assessed for a period of 5 years following the first dose of study treatment (placebo or plerixafor) in protocol AMD3100-3102 (phase 3). Patients will fall into 1 of 2 categories: patients who underwent transplant in protocol AMD3100-3102 and patients who did not undergo transplant in protocol AMD3100-3102. The schedule of follow-up contact will be based on whether or not a patient received a transplant.
• For those patients who underwent transplant in protocol AMD3100-3102 (including those who withdrew or were lost to follow-up), follow-up contact will occur every 6 months (± 3 months) beginning 18-months post-transplant or at study entry (i.e., signed informed consent), whichever is applicable, for a total follow-up period of 5 years following the first dose of study treatment.
• For those patients who did not undergo transplant in protocol AMD3100-3102, the first follow-up contact will occur at the time of study entry (i.e., signed informed consent); thereafter follow-up contact will occur every 6 months (± 3 months) for a total follow-up period of 5 years following the first dose of study treatment.
At study entry, patient history will be assessed. The following outcomes will be recorded by the Investigator at the time of study entry and at each follow-up contact:
• Death: Yes or No. If Yes, the date of death and whether or not it was disease-related will be recorded
• Disease progression/relapse: Yes or No. If Yes, the specific event and date of disease/progression relapse will be recorded. In addition, whether or not the patient received another transplant will be recorded.
At each follow-up contact, the Investigator will also record any additional treatments (e.g. transplant, chemotherapy, radiotherapy) received since the last study contact. |
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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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
This long-term observational study assesses disease-free survival and overall |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
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 | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |