A prospective randomised Phase II study of single agent pomalidomide maintenance versus combination pomalidomide and low dose dexamethasone maintenance following induction with the combination of pomalidomide and low dose dexamethasone in patients with relapsed and refractory myeloma previously treated with lenalidomide

Phase 2

Completed

Conditions: relapsed and refractory multiple myeloma
Cancer - Myeloma

Registration Number: ACTRN12612000338864

Lead Sponsor: Australasian Leukaemia and Lymphoma Group

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 80

Inclusion Criteria

At study entry:
Diagnosed with relapsed and refractory mutiple myeloma (MM) (diagnosis of MM as per International Myeloma Working Group (IMWG))
-Measurable M-component (monoclonal protein) in serum or urine,
-In patients with no detectable M-component, an abnormal Free light chain (FLC) ratio on the serum FLC assay
At least 2 prior therapies:
-Must include lenalidomide – failing to respond, disease progression during treatment or within 60 days of treatment completion (at least 2 cycles)
-May include autologous stem cell transplant (ASCT) (induction/ASCT/maintenance is one line of therapy).
Eastern Co-operative Oncology Group (ECOG) performance status 0-2
Adequate liver and kidney function (less than or equal to 2 x institutional upper limit of normal)
Haemoglobin (Hb) greater than or equal to 80g/L, Platelet count greater than or equal to 75 x 10^9, absolute neutrophil count greater than or equal to 1.0 x 10^9. Subjects who fail screening due to neutropenia or anaemia will not be permitted to use growth factors to become eligible.
No contraindication to the use of any of the study drugs
No concomitant steroids other than dexamethasone outlined in this protocol
Patient has voluntarily agreed and has given written informed consent.
Life expectancy of > 8 weeks
Patient must be greater than or equal to 4 weeks from prior chemotherapy, radiotherapy, biological therapy, immunotherapy, major surgery or any other investigational anti-cancer therapy prior to the first dose of study drug
Patients to comply with lenalidomide Pregnancy Prevention Plan
Study site must be able to get correlative samples to the Alfred Hospital, Melbourne, within 24 hours of collection.

Prior to randomisation:
Have completed 4 cycles of induction therapy
Have no evidence of progressive MM

Exclusion Criteria

At both registration and randomisation:
Patients with monoclonal gammopathy of uncertain significance.
Primary amyloidosis
Patients who have received prior allogeneic transplantation < 12 months prior to entering study
Patients who have had prior allogeneic transplantation and show evidence of active graft-versus-host disease that requires immunosuppressive therapy
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant or lactating women.
Known Hepatitis B, Hepatitis C, Human immunodeficiency virus (HIV) infection, other immunosuppressive therapy or autoimmune disease

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
atural killer (NK) cell quantification (an increase in 30% of NK cell numbers in pomalidomide arm compared to pomalidomide-dexamethasone): assessed by flow cytometry of CD3-CD56+CD16+ Peripheral Blood Mononuclear Cells (PBMC) that were collected at start of induction and at maintenance cycle 6.[at start of induction and at maintenance cycle 6];NK cell function (an increase of NK-cell lysis by 30% in the pomalidomide arm compared to pomalidomide-dexamethasone): assessed via lysis of 51Chromium-labelled K562, and myeloma cell lines (eg U266) in vitro at different effector: target ratios using patients' PBMC that were collected at start of induction and at maintenance cycle 6.[at start of induction and at maintenance cycle 6]

Secondary Outcome Measures

Name	Time	Method

Recruitment & Eligibility

Study & Design

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