EUCTR2005-000656-33-GBActive, not recruitingPhase 1
A Phase I/II Study of Sirolimus (Rapamune TM) in Combination with Cyclophosphamide and Dexamethasone in Relapsed Myeloma - SCD1 Trial
Royal Devon and Exeter NHS Foundation Trust0 sites18 target enrollmentStarted: May 9, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 18
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •· Patients with a previously established diagnosis of multiple myeloma who on the basis of a rise in the serum paraprotein level or urinary BJP excretion are relapsing from a 1st or subsequent complete or partial remission and who after routine restaging are considered to be unlikely to require radiotherapy for the next three months,
- •· WHO performance status of 0, 1 or 2,
- •· Age > 18 years,
- •· Negative pregnancy test if the patient is of childbearing potential,
- •· Signed consent form.
- •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
- •· Compressive symptoms due to soft tissue plasmacytomas,
- •· Anaemia (Hb < 10.0 g/dl),
- •· Neutropenia (neutrophils < 1.5 x 109/L),
- •· Thrombocytopenia (platelets < 75 x 109/L),
- •· Worsening renal function (rising plasma creatinine despite adequate hydration) or established renal failure with a serum creatinine > 300 mmol/L,
- •· Diabetes mellitus,
- •· Any treatment directed against the myeloma in the 30 days preceding trial entry,
- •· Treatment with any other investigational agent in the 30 days prior to trial entry,
- •· Previously demonstrated resistance to Dexamethasone.
Investigators
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