ROAR : A Phase Ib trial of oral azacitidine in combination with lenalidomide and dexamethasone (Rd) for myeloma patients with relapsed and/or refractory multiple myeloma who have failed a prior lenalidomide-containing regimen

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18-75Age 18-75

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaMultiple Myeloma

Trial Overview Read MoreRead more

This phase I trial is combining the oral drug azacitidine, with lenalidomide (a chemotherapy drug) and dexamethasone (a steroid) for the treatment of Multpile Myeloma.
 

This trial is treating patients with Multiple Myeloma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

A Phase Ib trial of oral azacitidine in combination with lenalidomide and dexamethasone (Rd) for myeloma patients with relapsed and/or refractory multiple myeloma who have failed a prior lenalidomide-containing regimen

Other Non-Commercial Sponsor

Alfred Health

Summary

This study will investigate the safety and tolerabilty of escalating doses of oral azacitadine in combination with a fixed dose of lenalidominde and dexamethasone in patients with relapased/refractory multiple myeloma. This study is for patients who have previously been diagnosed with multiple myeloma and who have previously been treated unsuccessfully with lenalidomide. The dose levels of oral azacitadine are: 1 (A) 100mg for days 1-14 of 28 day cycle 2 (B) 100mg for days 1-21 of 28 day cycle 3 (C) 150mg for days 1-14 of 28 day cycle 4 (D) 150mg for days 1-21 of 28 day cycle 5 (E) 200mg for days 1-14 of 28 day cycle 6 (F) 200mg for days 1-21 of 28 day cycle The fixed dose of lenalidomide is 25mg on Day 1 to 21 of each 28-day cycle. The fixed dose of dexamethasone is 40mg on Day 1, 8, 15 and 22 or each 28-day cycle. A total of up to 30 patients may take part in this trial. The first 3 patients will be enrolled in the lowest dose level 1(A). If this dose level is tolerated well by these patients, the next 3 patients will be enrolled in the next dose level 2(B), and so on until a dose level is reached where too many side effects are experienced. The dose level below the one with too many side effects will be declared the Maximum Tolerated Dose (MTD) and patients will drop back to this dose level and continue at this dose. This MTD dose level will be expanded to allow up to 22 patients to receive this dose. You may be eligible to join this study is you are above 18 years of age and have adequate liver, kidney and bone marrow function; have no contrainidications to the use of azacitidine, lenalidomide or dexamethasone; you provide consent; you have not had therapy for your multiple myeloma in the last 4 weeks and agree to practise abstinence or use contraception for the specified time period.

Recruiting Hospitals Read MoreRead more

Alfred Hospital, Malignant Haematology & Stem Cell Transplantation Service
Prahran
Ms Kate Reed
k.reed@alfred.org.au
03 9076 3571

Not Recruiting Hospitals Read MoreRead more

Closed

Barwon Health, University Hospital Geelong
Geelong
Dr Lea-Anne Harrison
leaanne.harrison@barwonhealth.org.au
03 42 15 2758

Monash Health Haematology Research Unit
Clayton
Ms Anita Cummins
anita.cummins@southernhealth.org.au
03 9594 4044

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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