A 2-stage Phase II study of combination pomalidomide and low dose dexamethasone therapy in patients with relapsed myeloma previously treated wtih lenalidomide maintenance post Autologous Stem Cell Transplant (LEOPARD follow-on study)

Phase 2

• Conditions: myeloma; Cancer - Myeloma

• Registration Number: ACTRN12615000447550
• Lead Sponsor: Alfred Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. 18+ years of age and be able to give informed consent

2. Confirmed diagnosis of multiple myeloma with progressive disease as per IMWG criteria

3. Patients must have evaluable multiple myeloma with, at least of the following:
- serum M-protein greater than or equal to 5g/L, or
- urine M-protein greater than or equal to 200mg/24 hour, or
- serum free light chain (SFLC) >100mg/L (involved light chain) and an abnormal kappa/lambda ratio (>4:1 or <2:1), or
- for IgA patients whose disease can only be reliably measured by serum quantitative immunoglobulin (total IgA) greater than or equal to 7.5g/L

4. Immediate therapy prior to relapse or progressive disease was lenalidomide maintenance as part of the LEOPARD study
-Note: Patients who discontinued LEOPARD study due to reasons other than progression (such as toxicity, consent withdrawal) and have subsequent relapse may be eligible for inclusion

5. Life expectancy of > 16 weeks

6. Patient must be greater than or equal to 7 days from prior focal radiotherapy, and greater than or equal to 2 weeks from last dose of lenalidomide and/or prednisolone, and/or major surgery prior to the first dose of study drug. No other anti-myeloma therapy is given between cessation of RAP maintenance and commencement of Pomalidomide therapy.

7. Adequate organ function and absence of any other absolute contraindications to the use of pomalidomide or dexamethasone

8. ECOG performance status 0-2

9. All women of childbearing potential must agree to have a negative pregnancy test in the 24hrs before commencing pomalidomide, take adequate precautions to prevent pregnancy, and not plan on conceiving children during or within 6 months following pomalidomide

10. All males must use barrier contraception during and for 4 weeks after completing pomalidomide.

Exclusion Criteria

N/A

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the response rates of salvage treatment with pomalidomide and low dose dexamethasone in patients with MM who develop progressive disease whilst on RAP maintenance post-ASCT.<br>Response rates to be measured using International Myeloma Working Group IMWG criteria. Assessments include serum protein electrophoresis and immunofixation, urine protein eletrophoresis and immunofixation, serum free light chain assay and Bone Marrow Aspirate Trephine.[at time of maximal response or progression or relapse]