Phase II Study of AB1010 in Patients With Relapse or Refractory Multiple Myeloma With t(4/14) Translocation Expressing or Not Expressing FGFR3
Inclusion Criteria:
- Confirmed multiple myeloma with a t (4; 14) translocation by FISH and PCR,
expressing or not expressing FGFR3 identified by FACS
- Patients with Multiple Myeloma progressing or relapsing after at least two prior
therapies (including conventional chemotherapy and/or high dose therapy) or who get
a reduction of M-protein less than 75% within 3 months after a high dose treatment
(Melphalan 200mg/m2) or after the plateau obtained for 3 months duration following to
a conventional chemotherapy
- Life expectancy > 3 months
- Patient with rapidly progressive disease with cytopenia and / or renal failure have
to be stabilized with chemotherapy (if possible 3 cycles of VTD (
Bortezomib/Thalidomide/dexamethasone) or high dose Melphalan regimen followed by a 4
weeks washout period before the inclusion in the study.
- Patients must have a clearly detectable and quantifiable monoclonal M- component
value (>5 g/l) in the serum and / or urine light chain excretion (>0,5 g/d)
- ECOG = 0 -2
Exclusion Criteria:
- Prior corticosteroids within two weeks before enrolment
- Prior local irradiation within two weeks before enrolment
- Prior experimental or standard treatment (other than steroids and local irradiation)
within 30 days before enrolment
- Contra-indication to high dose steroids (including ongoing active infection)
- Patient treated for a cancer other than MM within 5 years before enrolment, with the
exception of basal cell carcinoma or cervical cancer in situ