A Phase I/II Study of Sirolimus (Rapamune TM) in Combination with Cyclophosphamide and Dexamethasone in Relapsed Myeloma - SCD1 Trial

Phase 1

• Conditions: Plasma Cell Myeloma

• Registration Number: EUCTR2005-000656-33-GB
• Lead Sponsor: Royal Devon and Exeter NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-05-09
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>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