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New treatment option for Multiple Myeloma
Official title The Role of Ixazomib in Autologous Stem Cell Transplant in Relapsed Myeloma - Myeloma XII (ACCoRd)
ClinicalTrials.gov ID: NCT03562169
What this study is testing
What is Ixazomib, thalidomide, & dexamethasone (ITD) re-induction?
Ixazomib, thalidomide, & dexamethasone (ITD) re-induction is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for multiple myeloma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Study design: Randomised, controlled, multi-centre, open-label, phase III trial (with a single intervention registration phase). Primary Objectives The primary objectives of this study are to determine: The impact on Depth of Response (DoR: less than VGPR versus VGPR or better) when salvage ASCT conditioning is augmented by the addition of a proteasome inhibitor The influence of a consolidation and maintenance strategy on the Durability of Response (DuR:PFS) Secondary objectives The secondary objectives of this study are to determine: Overall survival Time to disease progression The overall response rate following ixazomib, thalidomide and dexamethasone (ITD) re-induction Time to next treatment Progression-free survival 2 (PFS2) Duration of response Minimal Residual Disease (MRD) negative rate post re-induction, post-ASCT and conversion after ITD consolidation Engraftment kinetics Toxicity and safety Quality of life (QoL) Participant population (refer to protocol section 9 for a full list of eligibility criteria).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosed with relapsed MM (with measurable disease, according to IMWG criteria (Appendix 2)) previously treated with ASCT).
- First Progressive Disease (PD) at least 12 months following first ASCT, requiring therapy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 (Appendix 3).
- Aged at least 18 years.
- Participants must have the following blood results within 14 days before registration:
You likely can't join if
- Received prior second line therapy for their relapsed disease other than local radiotherapy, therapeutic plasma exchange, or dexamethasone (up to a...
- ≥Grade 2 peripheral neuropathy within 14 days before registration.
- Known HIV seropositivity.
- Known resistance, intolerance or sensitivity to any component of the planned therapies.
- Any medical or psychiatric condition which, in the opinion of the investigator, contraindicates the participant's participation in this study.
- Previous or concurrent malignancies at other sites (excluding completely resected non-melanoma skin cancer or carcinoma in situ of any type, such as...
See the full eligibility criteria
Who can join
- Diagnosed with relapsed MM (with measurable disease, according to IMWG criteria (Appendix 2)) previously treated with ASCT).
- First Progressive Disease (PD) at least 12 months following first ASCT, requiring therapy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 (Appendix 3).
- Aged at least 18 years.
- Participants must have the following blood results within 14 days before registration:
- Absolute neutrophil count (ANC) ≥1x109/L
- Platelet count ≥75x109/L. If the participant has ≥50% bone marrow infiltration a platelet count of ≥50x109/L is allowed. Platelet transfusions are not allowed within 3 days before registration in order to meet these...
- Adequate renal function within 14 days before registration: a. Creatinine clearance ≥30ml/min (calculated according to the Cockcroft-Gault equation or other locally approved formula)
- Adequate hepatobiliary function within 14 days before registration:
- Total bilirubin \<2 x upper limit of normal (ULN)
- ALT \<2 x ULN
- Adequate pulmonary function within 14 days before registration: a. Adequate respiratory functional reserve (delineated by KCO/DLCO (carbon monoxide diffusion in the lung) of ≥50%). No evidence of a history of pulmonary...
- Adequate cardiac function within 12 weeks before registration a. Left ventricular ejection fraction (LVEF) ≥40%. Note: repeat confirmation of cardiac function is needed if treatment is given between this assessment and...
- Female participants who:
- Are not of childbearing potential (Appendix 8), OR
- If they are of childbearing potential (Appendix 8), agree to practice 2 effective methods of contraception (Appendix 8), at the same time, from the time of signing the informed consent form until 90 days after the last...
- Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not...
- Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR
- Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not...
- If female and of childbearing potential (see Appendix 8), must have a negative pregnancy test performed by a healthcare professional in accordance with the Celgene Thalidomide Pregnancy Prevention Programme.
- Patients agree not to receive other clinical trials treatment, including investigational medicinal products (IMPs) not included in this trial, within 30 days of trial registration and throughout the duration of the...
- Able to provide written informed consent.
What rules you out
- Received prior second line therapy for their relapsed disease other than local radiotherapy, therapeutic plasma exchange, or dexamethasone (up to a maximum of 200mg is allowed but not within 30 days prior to...
- ≥Grade 2 peripheral neuropathy within 14 days before registration.
- Known HIV seropositivity.
- Known resistance, intolerance or sensitivity to any component of the planned therapies.
- Any medical or psychiatric condition which, in the opinion of the investigator, contraindicates the participant's participation in this study.
- Previous or concurrent malignancies at other sites (excluding completely resected non-melanoma skin cancer or carcinoma in situ of any type, such as cervical cancer).
- Pregnant, lactating or breast feeding female participants.
- Failure to have fully recovered (i.e.Grade 1 or less toxicity) from the reversible effects of prior chemotherapy.
- Major surgery within 14 days before registration.
- Central nervous system involvement with myeloma.
- Ongoing or active infection requiring systemic antibiotic therapy or other serious infection within 14 days before registration.
- Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within...
- Systemic treatment, within 14 days before the first dose of ixazomib with strong CYP3A inducers (e.g. rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's...
- Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib, including difficulty swallowing.
- Patients that have previously been treated with ixazomib or participated in a study with ixazomib whether treated with ixazomib or not.
- Participant has current or prior hepatitis B or C infection.
The study team makes the final eligibility decision.
Where it's taking place
- Aberdeen, United Kingdom
- Airdrie, United Kingdom
- Ayr, United Kingdom
- Barnsley, United Kingdom
- Basingstoke, United Kingdom
- Bath, United Kingdom
- Birmingham, United Kingdom
- Blackpool, United Kingdom
- Boston, United Kingdom
- Bournemouth, United Kingdom
- Bradford, United Kingdom
- Bristol, United Kingdom
- Burton-on-Trent, United Kingdom
- Cambridge, United Kingdom
- Carshalton, United Kingdom
- Cheltenham, United Kingdom
- Chester, United Kingdom
- Chesterfield, United Kingdom
- Chichester, United Kingdom
- Coventry, United Kingdom
+ 61 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aberdeen, United Kingdom; Airdrie, United Kingdom; Ayr, United Kingdom; Barnsley, United Kingdom; Basingstoke, United Kingdom; Bath, United Kingdom and 75 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.