Plasma Cell Myeloma
Conditions
Interventions
Trade Name: Rapamune
Product Name: Rapamune
Pharmaceutical Form: Tablet
INN or Proposed INN: Sirolimus
Other descriptive name: Rapamycin
Concentration unit: mg milligram(s)
Concentration type: equal
C
Sponsors
Royal Devon and Exeter NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: · Compressive symptoms due to soft tissue plasmacytomas, · Anaemia (Hb 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determination of maximal tolerated dose of weekly Cyclophosphamide in combination with Sirolimus and Dexamethasone in patients with relapsed myeloma;Secondary Objective: Assessment of the toxicity of the combination of Sirolimus, Cyclophosphamide and Dexamethasone in patients with relapsed myeloma. Evaluation of the clinical activity of this drug combination in patients with relapsed myeloma.;Primary end point(s): Maximum tolerated dose of weekly Cyclophosphamide in combination with Sirolimus and Dexamethasone | — |
Countries
United Kingdom
Outcome results
None listed