Actively Recruiting
A Phase III Study to Determine the Role of Ixazomib in Salvage Autologous Stem Cell Transplant and Post-Transplant Consolidation and Maintenance in Relapsed Multiple Myeloma
Led by University of Leeds · Updated on 2018-06-19
406
Participants Needed
91
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Leeds
Lead Sponsor
C
Cancer Research UK
Collaborating Sponsor
AI-Summary
What this Trial Is About
The trial investigates the role of ixazomib in patients with relapsed multiple myeloma who have previously undergone autologous stem cell transplant ASCT. It is a phase III, randomized, controlled, multi-center, open-label study aiming to assess whether adding a proteasome inhibitor to salvage ASCT conditioning improves depth of response and how consolidation and maintenance therapy influence the durability of response. The study also evaluates overall survival, progression-free survival, response rates, minimal residual disease, toxicity, and quality of life. Participants first receive re-induction therapy with 4 to 6 cycles of ixazomib, thalidomide, and dexamethasone ITD, each cycle lasting 28 days. Those achieving at least stable disease are randomly assigned to receive either conventional ASCT using melphalan alone or augmented ASCT combining melphalan with ixazomib. After ASCT, participants with minimal response or better are further randomized to either receive consolidation with 2 cycles of ITD followed by ixazomib maintenance until disease progression or no further treatment. During the study, participants undergo regular assessments including response evaluation 100 days post-ASCT, monitoring of progression-free survival for up to 120 months, and measurement of minimal residual disease at several time points. Safety and toxicity are closely monitored throughout re-induction, post-ASCT, consolidation, and maintenance phases. Quality of life questionnaires are completed at baseline, post-re-induction, post-ASCT, and during follow-up visits up to 24 months. The study plans to register 406 participants, with 284 randomized at the first stage and 248 at the second stage.
CONDITIONS
Brief Title
The Role of Ixazomib in Autologous Stem Cell Transplant in Relapsed Myeloma - Myeloma XII (ACCoRd)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with relapsed multiple myeloma with measurable disease, previously treated with autologous stem cell transplant
- First progressive disease at least 12 months after first autologous stem cell transplant requiring therapy
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2
- Aged 18 years or older
- Adequate blood counts, including absolute neutrophil count of at least 1x10^9/L and platelet count of at least 75x10^9/L (50x10^9/L allowed if bone marrow infiltration is 50% or more)
- Adequate kidney function with creatinine clearance of at least 30 ml/min
- Adequate liver function with total bilirubin less than twice the upper limit of normal and ALT less than twice the upper limit of normal
- Adequate lung function with respiratory reserve at least 50% and no significant pulmonary disease
- Adequate heart function with left ventricular ejection fraction of at least 40%
- Women not of childbearing potential, or if of childbearing potential, agree to use two effective contraception methods or true abstinence until 90 days after last study drug dose
- Men agree to use effective barrier contraception or true abstinence until 90 days after last study drug dose
- Negative pregnancy test if female and of childbearing potential
- No other clinical trial treatments within 30 days before registration and during the study until disease progression
- Able to provide written informed consent
You will not qualify if you...
- Received second-line therapy for relapsed disease other than local radiotherapy, plasma exchange, or limited dexamethasone within 30 days before registration
- Peripheral neuropathy grade 2 or higher within 14 days before registration
- Known HIV infection
- Resistance or intolerance to planned therapies
- Medical or psychiatric conditions that prevent participation
- Other active cancers except certain treated skin or cervical cancers
- Pregnant or breastfeeding women
- Not fully recovered from previous chemotherapy toxicity
- Major surgery within 14 days before registration
- Central nervous system involvement with myeloma
- Active infection requiring antibiotics or serious infection within 14 days before registration
- Uncontrolled heart conditions including recent heart attack or unstable angina
- Use of strong CYP3A inducers or certain herbal supplements within 14 days before ixazomib dosing
- Gastrointestinal conditions interfering with oral drug absorption
- Prior treatment with ixazomib or participation in an ixazomib study
- Current or past hepatitis B or C infection
Research Team
G
Gwen Jacques, Senior Trial Coordinator
T
Trial Management Assistant
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