A Phase I/II trial of lenalidomide combined with cyclophosphamide and intermediate dose dexamethasone in patients with primary (AL) systemic amyloidosis - CDR in amyloidosis

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-007082-36-GR
• Date of registration: 18/07/2007
• Prospective Registration: Yes
• Primary sponsor: Hellenic Oncology Cooperative Group
• Public title: A Phase I/II trial of lenalidomide combined with cyclophosphamide and intermediate dose dexamethasone in patients with primary (AL) systemic amyloidosis - CDR in amyloidosis
• Scientific title: A Phase I/II trial of lenalidomide combined with cyclophosphamide and intermediate dose dexamethasone in patients with primary (AL) systemic amyloidosis - CDR in amyloidosis
• Date of first enrolment: 16/10/2007
• Target sample size: 55
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-007082-36
• 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: no Placebo: no Other: no

Countries of recruitment

Greece

Key inclusion & exclusion criteria

Inclusion criteria:
1. Understand and voluntarily sign an informed consent form.
2. Age >18 years at the time of signing the informed consent form.
3. Able to adhere to the study visit schedule and other protocol requirements.
4. Confirmed diagnosis of AL amyloidosis
5. Need for treatment in the judgment of their treating physician
6. Evaluable or measurable disease defined by any of the following:
I. Measurable serum free light chains > 10 mg/dL, kappa or lambda, provided ?/? ratio is abnormal (measurable disease) or abnormal ?/? ratio (evaluable)
II. monoclonal protein in the serum>1 g/dL
7. ECOG Performance Status (PS) 0, 1, 2 or 3
8. Laboratory test results within these ranges:
• Absolute neutrophil count >=1.0 x 109/L
• Platelet count >= 100 x 109/L
• Serum creatinine <= 2.5 mg/dL
• Total bilirubin < 2 mg/dL
• AST (SGOT) and ALT (SGPT) < 2 x ULN or <5 x ULN if liver involvement is present.
9. Women of childbearing potential (WCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL 10 – 14 days prior to therapy and repeated within 24 hours of starting study drug and must begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide. Women must also agree to ongoing pregnancy testing. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.
10. 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
11. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation. (patients intolerant to ASA may use low molecular weight heparin).

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:
1. Patients with symptomatic multiple myeloma with asymptomatic biopsy confirmed AL amyloidosis
2. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
3. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
4. 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.
5. Use of any other experimental drug or therapy within 28 days of baseline.
6. Known hypersensitivity to thalidomide.
7. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
8. Any prior use of lenalidomide.
9. Concurrent use of other anti-cancer agents or treatments.
10. Known positive for HIV or infectious hepatitis, type A, B or C.
11. >grade 2 peripheral neuropathy
12. Life expectancy < 3 months
13. Concurrent use of steroids (Patients may receive prednisone up to 20 mg/d, or equivalent corticosteroids for concurrent illness or adrenal replacement therapy



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

Health Condition(s) or Problem(s) studied

Primary (AL) amyloidosis in untreated patients or patientsw who have failed prior treatments

Intervention(s)

Trade Name: REVLIMID
Pharmaceutical Form: Capsule*

Trade Name: Endoxan
Pharmaceutical Form: Tablet

Trade Name: Dexamethasone
Pharmaceutical Form: Tablet

Trade Name: REVLIMID
Pharmaceutical Form: Capsule*
INN or Proposed INN: Lenalidomide
CAS Number: 191732-72-6
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 5-25
INN or Proposed INN: Deaxamethasone
CAS Number: 50-02-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
INN or Proposed INN: cyclophosphamide
CAS Number: 50-18-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Secondary Objective: • To assess the toxicity of Cyclophosphamide/Dexamethasone plus lenalidomide combination in patients with AL amyloidosis.

• To assess organ response rate of Cyclophosphamide/Dexamethasone plus lenalidomide combination in patients with AL amyloidosis.

Main Objective: • To assess the maximum tolerated dose of lenalidomide in combination with Cyclophosphamide and Dexamethasone in patients with AL amyloidosis.

• To assess the hematologic response rate of the combination of Cyclophosphamide/Dexamethasone plus lenalidomide in patients with AL amyloidosis

Primary end point(s): • Hematologic and organ progression free survival

Secondary ID(s)

RV178