A phase II study of lenalidomide and prednisolone as post-autologous stem cell transplant (ASCT) maintenance therapy for patients with Multiple Myeloma incorporating residual disease monitoring.

Phase 2

Recruiting

• Conditions: Residual Multiple Myeloma in patients post autologous stem cell transplant.; Blood - Haematological diseases; Cancer - Myeloma

• Registration Number: ACTRN12611000597998
• Lead Sponsor: Malignant haematology and stem cell transplant Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

At registration pre-ASCT
-Age over 17 years
-Diagnosis of multiple myeloma as per IMWG
criteria
-No more than 12 months total prior standard-
dose chemotherapy.
-No previous high-dose chemotherapy or
autologous transplantation procedure.
-ECOG performance status 0, 1, or 2.
-Normal liver and kidney function (within 2 x the
institutional upper limit of normal).
-No contraindication to the use of any of the study
drugs
-Greater than or equal to 2.0 x 106/kg CD34+ stem cells available for
infusion.
-Written informed consent.

To commence RAP post-ASCT
-Have reached Day 42 post-ASCT with evidence of
haemopoietic reconstitution (neutrophils > 1.5 x 109/litre
and platelets unsupported >50 x 109/litre).
-No evidence of progressive myeloma.
-All women of childbearing potential must agree to
have a negative pregnancy test in the 24hrs before
commencing lenalidomide,
take adequate precautions to prevent pregnancy,
not plan on conceiving children during or within 6 months
following lenalidomide.
-All male participants must use barrier contraception during
and for 4 weeks after completion of lenalidomide.
-No contraindication to prednisolone or lenalidomide
-Have an ECOG performance status of 0 – 2.

Exclusion Criteria

-Patients with monoclonal gammopathy of uncertain
significance.
-Patients with progressive MM pre or post stem cell
transplant.
-Patients whose general condition makes them unsuitable
for intensive treatment e.g. significant cardiac or
pulmonary disease.
-Active infections or other illnesses that would preclude
conditioning chemotherapy or maintenance therapy
administration or patient compliance.
-Pregnant or lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified