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PHASE II STUDY ON TREATMENT WITH VELCADE, DEXAMETHASONE AND FOTEMUSTINE IN PATIENTS AFFECTED BY RELAPSED/REFRACTORY MULTIPLE MYELOMA - B-MUD

PHASE II STUDY ON TREATMENT WITH VELCADE, DEXAMETHASONE AND FOTEMUSTINE IN PATIENTS AFFECTED BY RELAPSED/REFRACTORY MULTIPLE MYELOMA - B-MUD

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-011838-10-IT
Enrollment
Unknown
Registered
2009-04-16
Start date
2009-04-27
Completion date
Unknown
Last updated
2013-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed/refractory Multiple Myeloma MedDRA version: 9.1 Level: LLT Classification code 10028228 Term: Multiple myeloma

Interventions

Trade Name: MUPHORAN Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: Fotemustine Concentration unit: mg milligram(s) Concentration type: equal Concentration numb

Sponsors

OSPEDALE POLICLINICO S. MATTEO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Documented relapsed or progressive disease after al least one previous therapy; age > 18; Performance status score > 60%; MM documented in serum or urine; absence of severe disease or concomitant neoplasia; Negative HIV test; Negative pregnancy test; Laboratory values within the protocol limits. 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

Exclusion criteria: Pregnancy or breast-feeding; neuropathy >= grade 2 NCI; concomitant biological therapy, immunotherapy or other experimental drugs in the previous 21 days; plasmapheresis in the previous 30 days; Major surgery in the previous 30 days.

Design outcomes

Primary

MeasureTime frame
Main Objective: Evaluation of toxicity of the treatment with Fotemustine associated with Bortezomib and high-dose Dexamethasone in patients affected by relapsed/refractory multiple myeloma after at least one previous therapy.;Secondary Objective: Time to progression(TTP); Time to next treatment (TTNT); Progression free Survival (PFS); Overall Survival (OS); Complete + Partial Response (CR+PR); Time to Response; Response Duration.;Primary end point(s): Number of patients with toxicity at maximum dose—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026