Evaluation of efficacy and safety of Lenalidomide (Revlimid) in patients with POEMS Syndrome - ONC-2008-002

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-003202-33-IT
• Date of registration: 17/11/2009
• Prospective Registration: No
• Primary sponsor: ISTITUTO CLINICO HUMANITAS
• Public title: Evaluation of efficacy and safety of Lenalidomide (Revlimid) in patients with POEMS Syndrome - ONC-2008-002
• Scientific title: Evaluation of efficacy and safety of Lenalidomide (Revlimid) in patients with POEMS Syndrome - ONC-2008-002
• Date of first enrolment: 15/09/2009
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-003202-33
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Italy

Key inclusion & exclusion criteria

Inclusion criteria:
1. Age > 18 years
2. Patients with a diagnosis of POEMS syndrome based on published diagnostic criteria (Appendix B POEMS syndrome Diagnostic Criteria)
3. Patients with at least a moderate impairment due to neuropathy corresponding to an ONLS of 2 or more
4. Patients with a Karnofsky performance status = 60%
5. Patients with a life-expectancy > 6 months.
6. Patients willing and able to comply with the protocol requirements,
7. Patients who have given voluntary written informed consent before any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
8. Female patient should be either post-menopausal or surgically sterilised or willing to use two acceptable method of birth control. The two methods of reliable contraception must include one highly effective method (i.e. intrauterine device (IUD), hormonal except oral formulations, 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.
9. Male patient should agree to use an acceptable method for contraception (i.e., condom or abstinence) for the duration of the study.
10. Patients with the following laboratory values within 14 days before day 1 of the Cycle 1:
Absolute neutrophil count > 1.5 x 109/L without the use of growth factors;
Platelets count > 75 x 109/L without transfusion support within 7 days before the test
Calculated or measured creatinine clearance: = 20 mL/minute
Total bilirubin < 1.5 x the ULN
AST (SGOT) and ALT (SGPT) < 2.5 x ULN
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
2. Pregnant or breast feeding females.
3. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk.
4. Use of any other concomitant standard/experimental drug or therapy
5. Any prior use of Revlimid
6. Any of the following laboratory abnormalities:
Platelets count < 75 ? 109/L
Absolute neutrophils count <1.5 ? 109/L
Calculated or measured creatinine clearance <20 mL/minute.
7. Known positive HIV or active infectious hepatitis, type B or C


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

POEMS SYNDROME
MedDRA version: 9.1 Level: SOC Classification code 10029205

Intervention(s)

Trade Name: REVLIMID*21CPS 25MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Lenalidomide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Primary Outcome(s)

Secondary Objective:  Evaluation of the safety of RD combination
 Evaluation of the activity of RD combination in VEGF/pro-inflammatory cytokine serum levels reduction after 6 cycles
 Evaluation of clinical efficacy of RD combination in terms of improvement of muscle strength assessed by the expanded MRC sum score after 6 cycles
 Evaluation of clinical efficacy of RD combination in terms of improvement of sensation assessed by the INCAT sensory sum score after 6 cycles
 Evaluation of clinical efficacy of RD combination in terms of improvement of motor conduction velocity, distal latency and distal CMAP amplitude in one upper limb and one lower limb nerve.

Main Objective:  Evaluation of clinical efficacy of RD combination in patients with POEMS syndrome, in terms of improvement of either the disability caused by the neuropathy (ONLS) or organ specific symptoms (appendix D) after 6 cycles.

Primary end point(s):  Evaluation of clinical efficacy of RD combination in patients with POEMS syndrome, in terms of improvement of either the disability caused by the neuropathy (ONLS) or organ specific symptoms (appendix D) after 6 cycles.

Secondary ID(s)

ONC -2008-002