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Phase II Study of AB1010 in Patients With Relapse or Refractory Multiple Myeloma With t(4/14) Translocation Expressing or Not Expressing FGFR3


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor Response Rate, based on the criteria published by Blade and on the criteria SWOG

Safety Issue:

No

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

AB04019

NCT ID:

NCT00866138

Start Date:

February 2005

Completion Date:

December 2010

Related Keywords:

  • Multiple Myeloma
  • multiple myeloma
  • t(4/14)
  • relapsing
  • refractory
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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