ACTRN12613000283774TerminatedPhase 1
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
The Alfred Hospital0 sites30 target enrollmentStarted: March 8, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomised trial
- Primary Purpose
- Treatment
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
Inclusion Criteria
- •1. Age 18 years and above
- •2. Confirmed diagnosis of MM as per IMWG criteria
- •3. ECOG performance status 0-2
- •4. Relapsed and/or refractory MM with a history of lenalidomide failure where lenalidomide failure is defined as
- •a) Progressive disease while on a lenalidomide containing regimen OR b) Progressive disease within 60 days of completing a lenalidomide containing regimen OR c)Failure to achieve at least a minimal response (MR) with 4 cycles of lenalidomide containing therapy when such therapy was administered either as part of initial therapy for newly diagnosed MM or as salvage therapy for the treatment of relapsed/refractory MM.
- •5. Adequate liver and kidney function (<2 x institutional upper limit of normal)
- •6. Platelet count > 75 x 109/L, absolute neutrophil count > 1.0 x 109/L
- •7. No contraindication to the use of azacitidine, lenalidomide or dexamethasone
- •8. Patient has voluntarily agreed and has given written informed consent.
- •9. Life expectancy of > 8 weeks
- •10. Patient must be >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
- •11. All females of childbearing potential (FOCBP)** must agree to have two negative pregnancy tests in the 24hrs before commencing lenalidomide and use two reliable methods of contraception simultaneously or to practice complete abstinence from any sexual contact during the following time periods related to this study: 1) for at least 28 days before starting study; 2) while participating in the study; 3) dose interruptions; and 4) for at least 28 days after study treatment discontinuation. The two methods of reliable contraception must include one highly effective method and one additional effective method to prevent pregnancy, not plan on conceiving children during or within 6 months following lenalidomide
- •12. All male participants must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy.
- •** A female of childbearing potential is defined as a sexually mature woman who: 1 has not undergone a hysterectomy or bilateral oophorectomy or 2, has not been naturally post-menopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (I.e, has had menses at any time in the preceding 24 consecutive months).
Exclusion Criteria
- •1. Patients with monoclonal gammopathy of uncertain significance.
- •2. Primary amyloidosis
- •3. Patients who have received prior allogeneic transplantation < 12 months prior to entering study
- •4. Patients who have had prior allogeneic transplantation and show evidence of active graft-versus-host disease that requires immunosuppressive therapy
- •5. 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
- •6. Patients with a prior malignancy within the last 5 years (except for basal or squamous cell carcimnoma or in situ cancer of the cervix).
- •7. Pregnant or lactating women.
- •8. Known hepatitis B, Hepatitis C, HIV infection, other immunosuppressive therapy or autoimmune disease
Investigators
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