Clinical trial NCT00452569 (phase 3, status: completed)
Conditions: multiple myeloma
ICD codes: C90.01, C90.02, C90.00
Drugs: thalidomide, dexamethasone
SMILES: CC(C)NCC(O)COC1=CC=CC2=C1C=CC=C2, C[C@@H](O[C@H]1OCCN(CC2=NNC(=O)N2)[C@H]1C1=CC=C(F)C=C1)C1=CC(=CC(=C1)C(F)(F)F)C(F)(F)F
Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients, aged ≥ 18 years at the time of signing the informed consent
             form

          -  Patients who have been previously diagnosed with MM who have received between 1 & 3
             prior lines of treatment for their disease, and who require therapy because of disease
             progression

          -  Secretory MM with measurable levels of monoclonal protein in serum (> 10 g/L of IgG
             M-protein or > 5 g/L of IgA M-protein) or urine (≥ 200 mg/ 24hours); Patient with the
             following rare subclasses of the immunoglobulin: IgD, IgE, IgM can be included in the
             study if the level of monoclonal protein in serum is > 5g/L or ≥ 200 mg/24hours in
             urine. As IgM immunoglobulin isotype can be related to Waldenstrom's
             macroglobulinemia, it is important to distinguish and not include in the study
             patients with Waldenstrom's macroglobulinemia.

          -  ECOG performance status of 0, 1, or 2

          -  Life expectancy >3months

          -  Able to adhere to the study visit schedule & other protocol requirements

          -  Women of child-bearing potential must agree to use 2 methods of contraception for at
             least 4weeks before starting the therapy, during the Treatment Period, & for 4 weeks
             after the last dose

          -  Males must agree to use barrier contraception (latex condoms) when engaging in
             reproductive activity during the Treatment Period & for 4 weeks after the last dose

          -  Written, informed consent

        Exclusion Criteria:

          -  Any serious medical condition, laboratory abnormality, or psychiatric illness that
             would prevent the patient from signing the Informed Consent Form

          -  Pregnant or lactating women. A serum β-hCG pregnancy test must be performed at the
             Screening visit for female patients of child-bearing potential. If the test is
             positive, the patient must be excluded from the study. Confirmation that the patient
             is not pregnant must be established by a negative serum or urinary pregnancy test with
             the result obtained 1day prior to the Baseline visit (or the day of the visit if
             results are available before drug delivery). A pregnancy test is not required for
             naturally post-menopausal women (who have not had menses at any time in the preceding
             24 consecutive months) or surgically sterilized women (hysterectomy, bilateral
             ovariectomy, bilateral salpingectomy)

          -  Non-secretory MM

          -  Any of the following laboratory abnormalities: Absolute neutrophil count (ANC) <500
             cells/mm3 (0.5 x 109/L); Platelet count <30,000/mm3 (30.0 x 109L) without transfusion
             support within 7 days before the test; Serum creatinine >3.0mg/dL (265μmol/L); Serum
             aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) >3.0 x upper
             limit of normal (ULN); Serum total bilirubin >2.0mg/dL (34μmol/L)

          -  Any condition, including the presence of laboratory abnormalities, which places the
             patient at unacceptable risk if s/he were to participate in the study, or which
             confounds the ability to interpret data from the study

          -  Severe cardiac dysfunction (according to the New York Heart Association [NYHA]
             classification III-IV)

          -  Severe bradycardia (<50bpm)

          -  Peripheral neuropathy ≥Grade 2 in severity (according to the NCI CTC Version 3.0)

          -  Prior history of malignancy (except for basal cell or squamous cell carcinoma of the
             skin or carcinoma in situ of the cervix or breast) unless the patient has been free of
             disease for ≥5years

          -  Patient received any chemotherapy, corticosteroids (> 10 mg/day prednisone or
             equivalent as a continuous dose) within 4 weeks before randomization

          -  Previously treated with thalidomide or thalidomide derivatives

          -  Patients refractory to high-dose dexamethasone (defined as experiencing less than a PR
             to dexamethasone, or PD within 6months after discontinuing dexamethasone, or
             discontinued dexamethasone because of ≥Grade 3 dexamethasone-related toxicity.
             Previous high-dose dexamethasone therapy is defined as >500mg dexamethasone or
             equivalent over a 10week period, whether administered alone or as part of the VAD
             regimen)

          -  Contraindications for high-dose dexamethasone

          -  Active or chronic gastrointestinal ulcers, active viral infections (herpes, varicella,
             HIV, hepatitis B, hepatitis C), glaucoma, uncontrolled hypertension, or diabetes
             mellitus, unless well controlled & under strict supervision during dexamethasone
             treatment

          -  Patient enrolled in another clinical trial or who have participated in another trial
             with the last 4weeks before randomization