E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Previously treated subjects with Multiple Myeloma |
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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 provide lenalidomide to subjects with a high likelihood of benefit. |
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E.2.2 | Secondary objectives of the trial |
•To obtain additional safety data. •To assess the impact on quality of life (QoL).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Signed informed consent. •At least 18 years of age. •Able to adhere to the study visit schedule and other protocol requirements. •Relapsed with refractory multiple myeloma •Measurable levels of myeloma protein in serum (>=0.5 g/dL) or urine (>=0.2 g / 24-hour urine collection). •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 – 2. •Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study. The two methods of reliable contraception must include one highly effective method (i.e. intrauterine device (IUD), hormonal [injections, or implants], tubal ligation, partner’s vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). Combined oral contraceptive pills are not recommended because they carry an increased risk of venous thromboembolism. If a patient is currently using combined oral contraception switching to another adequate method of contraception should be considered. The risk of venous thromboembolism continues for 4 to 6 weeks after discontinuing combined oral contraception. If alternative methods are unacceptable, thromboprophylaxis should be considered while continuing combined oral contraception. The patient should be adequately informed about the risks of venous thromboembolism. FCBP must be referred to a qualified provider of contraceptive methods if needed. Before starting study drug: Female Subjects: •FCBP must have two negative pregnancy tests (sensitivity of at least 50 mIU/mL) prior to starting study drug. The first pregnancy test must be performed within 10-14 days prior to the start of study drug and the second pregnancy test must be performed within 24 hours prior to the start of study drug. The subject may not receive study drug until the Investigator has verified that the results of these pregnancy tests are negative. •Will be warned that sharing study drug is prohibited and will be counseled about pregnancy precautions and potential risks of fetal exposure. •Must agree to abstain from donating blood during study participation and for at least 28 days after discontinuation from the study. Male Subjects: •Must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days following discontinuation from the study even if he has undergone a successful vasectomy. •Will be warned that sharing study drug is prohibited and will be counseled about pregnancy precautions and potential risks of fetal exposure. •Must agree to abstain from donating blood, semen, or sperm during study participation and for at least 28 days after discontinuation from the study.
During study participation and for 28 days following discontinuation from the study: All Subjects: •No more than a 28-day supply of study drug will be dispensed at a time. Female Subjects: •FCBP with regular cycles must agree to have pregnancy tests weekly for the first 28 days of study participation and then every 28 days while on study, at study discontinuation, and at day 28 following discontinuation from the study. If menstrual cycles are irregular, the pregnancy testing must occur weekly for the first 28 days and then every 14 days while on study, at study discontinuation, and at days 14 and 28 following discontinuation from the study. •In addition to the required pregnancy testing, the Investigator must confirm with FCBP that she is continuing to use two reliable methods of birth control at each visit. •Counseling about pregnancy precautions and the potential risks of fetal exposure must be conducted at a minimum of every 28 days. During counseling, subjects must be reminded to not share study drug and to not donate blood. •Pregnancy testing and counseling must be performed if a subject misses her period or if her pregnancy test or her menstrual bleeding is abnormal. Study drug treatment must be discontinued during this evaluation. •Females must agree to abstain from breastfeeding during study participation and for at least 28 days after discontinuation from the study.
Male Subjects: •Counseling about the requirement for latex condom use during sexual contact with females of childbearing potential and the potential risks of fetal exposure must be conducted at a minimum of every 28 days. During counseling, subjects must be reminded to not share study drug and to not donate blood, sperm, or semen.
If pregnancy or a positive pregnancy test does occur in a study subject or the partner of a male study subject during study participation, study drug must be immediately discontinued.
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E.4 | Principal exclusion criteria |
•Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. •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. •Any of the following laboratory abnormalities: - Absolute neutrophil count (ANC) <1,000 cells/mm3 (1.0 x 10^9/L) - Platelet count <75,000/mm3 (75 x 10^9/L) for subjects in whom <50% of the bone marrow nucleated cells are plasma cells. - Platelet count <30,000/mm3 (30x10^9/L) for subjects in whom >=50% of bone marrow nucleated cells are plasma cells. - Serum creatinine >2.5 mg/dL (221 umol/L) - Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN) - Serum total bilirubin >2.0 mg/dL (34 umol/L) •Prior history of malignancies other than multiple myeloma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for >=1 year. •Known hypersensitivity to thalidomide or dexamethasone. •Prior history of uncontrollable side effects to dexamethasone therapy. •The development of a desquamating rash while taking thalidomide. •Neuropathy >= Grade 2.
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E.5 End points |
E.5.1 | Primary end point(s) |
•Safety (type, frequency, severity, and relationship of adverse events to study drug). •Quality of life (QoL) assessment (European Organization for Research and Treatment of Cancer QoL Questionnaire for Patients with Cancer [EORTC QLQ- C30] and QoL Questionnaire for Patients with Multiple Myeloma [QLQ- MY24] Module)
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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 | Yes |
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 | 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) | 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 | 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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 99 |
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 | Yes |
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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The end of the study is defined as when the last subject remaining on study makes his or her final visit to the clinic. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 10 |