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About
This study is a Multicenter, Open-label, Phase II study of ixazomib, plus Pomalidomide and Dexamethasone regimen (IPD) in RRMM with adverse Genomic Abnormalities.
Full description
There is no escalation dose study, the maximum tolerated dose has already been determined in previous phase 1 escalation dose studies. The proposed dose of dexamethasone is considered standard. Patients will receive the IPd regimen until progression.
The hypothesis is that this IPd regimen based combination will eventually improve time to disease progression, with no additional toxicity, as compared to other available regimens, in this subgroup of patients with myeloma characterized with a very adverse prognosis.
Study design. This trial will study the efficacy and safety of IPd regimen in Relapsed and Refractory Multiple Myeloma with adverse Genomic Abnormalities until progression in 2 separate phases.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Male or female patients 18 years or older.
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
Life expectancy > 3 months.
Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2.
Presence - at diagnosis or at relapse - of one of the following adverse genomic abnormalities determined using Interphase fluorescence in situ hybridization and Single nucleotide polymorphism (FISH/SNP) techniques at a significant rate validated centrally by Pr AVET - LOISEAU:
Must have an RRMM and have received a Lenalidomide line of treatment
Must have a Progressive Multiple Myeloma (MM) according to IMWG consensus recommendations for multiple myeloma treatment response criteria (DURIE 2007, RAJKUMAR 2011) :
Must have a measurable disease as defined by the following:
Patients must meet the following clinical laboratory criteria:
Able to undergo antithrombotic prophylactic treatment. HBPM (low weight heparin) is preferred. In case of anti-Vitamin K Agent, INR (international normalized ratio) must be used
Female patients who:
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:
Patients agree:
Must be able to adhere to the study visit schedule and other protocol requirements including the pregnancy prevention program as detailed in section 13.4 of protocol
Affiliated with an appropriate social security system.
Exclusion criteria
Any other uncontrolled medical condition or comorbidity that might interfere with subject's participation.
Patients not having receive Lenalidomide
Pregnant or breast feeding females
Known positive for HIV or active hepatitis type B or C.
Patients with non-secretory MM
Patient with terminal renal failure that require dialysis and clearance creatinine < 30ml/min
Prior history of malignancies, other than multiple myeloma, unless the patients has been free of the disease for ≥ 5 years.
Prior local irradiation within two weeks before first dose*
*However, an exception (that is patients allowed to remain in the treatment phase of the study) is made for radiation therapy to a pathological fracture site to enhance bone healing or to treat post-fracture pain that is refractory to narcotic analgesics because pathologic bone fractures do not by themselves fulfill a criterion for disease progression.)
Evidence of central nervous system (CNS) involvement
Unable to take corticotherapy at study entry, Ixazomib or pomalidomide
Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment
Ongoing Cardiac dysfunction: specify e.g. uncontrolled hypertension, MI (Myocardial Infarction) within 6 months, unstable Angina pectoris, Cardiac arrhythmia Grade 2 or higher
Patients planned to receive a transplantation while on IPd protocol
Patients who have had Ixazomib and Pomalidomide therapy as a previous line
Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial.
Failure to have fully recovered (ie, ≤ Grade 1 toxicity) from the reversible effects of prior chemotherapy.
Inability or unwillingness to comply with birth control requirements
Unable to take antithrombotic medicines at study entry
Major surgery within 14 days before enrollment.
Systemic treatment, within 14 days before the first dose of ixazomib and Pomalidomide, with strong CYP3A (Cytochrome P450 3A) inducers (rifampicin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. John's wort.
Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib and Pomalidomide including difficulty swallowing.
Patient has ≥ Grade 3 peripheral neuropathy, or Grade 2 with pain on clinical examination during the screening period.
Patients that have previously been treated with ixazomib, or participated in a study with ixazomib whether treated with ixazomib or not.
Subjects under juridical protection guardianship or tutelage measure
Primary purpose
Allocation
Interventional model
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26 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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