Multiple Myeloma Clinical Trial
A Study of Ixazomib, Given With Dexamethasone in Adults With Multiple Myeloma
The main aim of this study is to learn if ixazomib, given with dexamethasone, stops the cancer from getting worse in people with relapsed or refractory multiple myeloma. It will be compared to another medicine called pomalidomide, given with dexamethasone with people with the same condition. Relapsed means the previous cancer treatment stopped working, over time. Refractory means they did not respond to previous cancer treatment. Another aim is to check for side effects from the study medicines.
At the first visit, the study doctor will check who can take part. Participants who can take part will be picked for 1 of 2 treatments by chance.
Ixazomib capsules, given with dexamethasone tablets
Pomalidomide capsules, given with dexamethasone tablets
All participants will take their study medicine on specific days during a 28-day cycle.
The 1st dose of study medicines in each 28-day cycle will take place in the clinic, The other doses of the study medicines will be taken at home. This will happen for 6 cycles. After this, all study medicines will be taken at home.
After treatment, participants will visit the clinic every 12 weeks for a check-up.
If participants cannot attend their clinic for an important reason (for example, due to the COVID-19 pandemic), the clinic will make alternative arrangements using their local procedures.
The drug being tested in this study is called Ixazomib. Ixazomib is being tested to treat people who have relapsed and/or refractory multiple myeloma (RRMM). This study will compare the efficacy and safety in participants who take ixazomib and dexamethasone to pomalidomide and dexamethasone. It is an open-label, Phase 2 study.
The study will enroll approximately 120 participants. Participants will receive:
Ixazomib 4 mg + dexamethasone 20 mg (or 10 mg if participant is aged >=75 years) OR
Pomalidomide 4 mg + dexamethasone 40 mg (or 20 mg if participant is aged >=75 years)
All participants will be asked to take either ixazomib plus dexamethasone (in cases where only 4 mg tablets for dexamethasone are available, the following dexamethasone schedule is recommended for participants aged >=75 years: 12 mg dexamethasone will be given on Days 1, 8, 15, and 22 of every 28-day cycle; and 8 mg dexamethasone will be given on Days 2, 9, 16, and 23 of every 28-day cycle) or pomalidomide 4 mg + dexamethasone 40 mg at recommended doses.
This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 28 months after the first participant enters the study.
Participants will make multiple visits to the clinic, and will be contacted for progression free-survival (PFS) follow-up, in case of study drug discontinuation for up to 4 years from first dose administration. After disease progression, participants will be followed-up for overall survival (OS) every 12 weeks until death or up to 4 years.
Alternative methods for administering study procedures/assessments may be considered when it is not possible for the participants to come to the study site due to extenuating circumstances (e.g., due to the COVID-19 pandemic).
Must have a confirmed diagnosis of multiple myeloma (MM) requiring therapy according to International Myeloma Working Group (IMWG) criteria.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Must have had a relapse or progressive disease (PD) after having received 2 or more prior lines of systemic therapy. Note: A line of therapy is defined as 1 or more cycles of a planned treatment program; this may consist of 1 or more planned cycles of single-agent therapy or combination therapy, as well as a sequence of treatments administered in a planned manner. For example, a planned treatment approach of induction therapy followed by autologous stem cell transplantation (SCT), followed by maintenance is considered 1 line of therapy. Typically each line of therapy is separated by PD. Discussion with the medical monitor may help clarify the number of lines of therapy that a prospective study participant had.
Must be refractory to lenalidomide, defined as having received at least 2 consecutive cycles of lenalidomide as a single agent or within a lenalidomide-containing regimen and having had PD during treatment with or within 60 days after the last dose of lenalidomide. The starting dose of lenalidomide should have been 25 mg (or as low as 10 mg in the case of renal function impairment or other safety concern), and the final dose should have been a minimum of 10 mg.
Must have received at least 2 consecutive cycles of a bortezomib- or carfilzomib-containing regimen, and either:
Achieved at least a partial response (PR) and did not have PD during treatment with or within 60 days after the last dose of bortezomib or carfilzomib, OR
Had bortezomib and/or carfilzomib intolerance (defined as discontinuation because of drug-related adverse events [AEs] before completion of the planned treatment course) without PD before the start of the next regimen.
Must have measurable disease defined by:
Serum M-protein >=1 g/dL (>=10 g/L), OR
Urine M-protein >=200 mg/24 hours and must have documented MM isotype by immunofixation (central laboratory).
Suitable venous access for the study-required blood sampling, including pharmacokinetic (PK) sampling.
Recovered (that is, less than or equal to [<=] Grade 1 nonhematologic toxicity) from the reversible effects of prior anticancer therapy.
Must be willing and able to adhere to pomalidomide-related risk mitigation activities if randomized to the pom+dex arm (example, Risk Evaluation and Mitigation Strategies [REMS], pregnancy prevention programs).
Prior allogenic bone marrow transplantation in any prior line of therapy or prior autologous SCT in the last prior line of therapy- unless the autologous SCT was performed a year or more before disease progression.
Diagnosed with or treated for another malignancy within 2 years before randomization, or previously diagnosed with another malignancy and have any evidence of residual, persistent, or recurrent disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
Diagnosis of smoldering MM, Waldenström's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome.
Peripheral neuropathy Grade 1 with pain or Grade 2 or higher peripheral neuropathy of any cause on clinical examination during the Screening period.
Treatment with any investigational products or with chimeric or fully human monoclonal antibodies within 30 days before randomization, systemic anticancer therapy or radiotherapy within 14 days before randomization (Note: "spot" radiation for areas of pain is permitted), and major surgery within 14 days before randomization.
Known gastrointestinal disease or gastrointestinal procedure that could interfere with the oral absorption or tolerance of study therapy, including difficulty swallowing.
Serious infection requiring parenteral antibiotic therapy or any other serious infection within 14 days before randomization.
Central nervous system involvement with MM (by clinical symptoms and signs).
Ongoing or active systemic infection, known human immunodeficiency virus-ribonucleic acid (RNA) positive, known hepatitis B surface antigen seropositive, or known hepatitis C virus-RNA positive.
Systemic treatment with strong cytochrome P-450 3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital) or use of St. John's wort within 14 days before randomization.
Admission or evidence of illicit drug use, drug abuse, or alcohol abuse.
History of severe cutaneous reactions, including hypersensitivity reactions such as Stevens-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), in the context of treatment with lenalidomide or thalidomide.
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There are 107 Locations for this study
Fayetteville Arkansas, 72703, United States
Santa Rosa California, 95403, United States
Boca Raton Florida, 33486, United States
Gainesville Florida, 32610, United States
Baltimore Maryland, 21201, United States
Detroit Michigan, 48202, United States
Lansing Michigan, 48910, United States
Rochester Minnesota, 55905, United States
Farmington New Mexico, 87401, United States
Toledo Ohio, 43614, United States
South Brisbane Queensland, 4101, Australia
Woodville South South Australia, 5011, Australia
Box Hill Victoria, 3128, Australia
Fitzroy Victoria, 3065, Australia
Adelaide , , Australia
Wilrijk Antwerpen, 2610, Belgium
Brugge , 8000, Belgium
Barrie Ontario, L4M 6, Canada
Ottawa Ontario, L1G 2, Canada
Hradec Kralove Kralovehradeck Kraj, 500 0, Czechia
Olomouc Olomouck Kraj, 775 2, Czechia
Prague Praha, Hlavni Mesto, 100 3, Czechia
Praha Praha, Hlavni Mesto, 128 0, Czechia
Brno , 625 0, Czechia
Ostrava , , Czechia
Plzen Lochotin , 304 6, Czechia
Aalborg Nordjylland, 9100, Denmark
Holstebro , 7500, Denmark
Nice Alpes-Maritimes, 06189, France
Dijon Cote-d'Or, 21034, France
Brest Finistere, 29609, France
Vandoeuvre Les Nancy Meurthe-et-Moselle, 54511, France
Vannes Morbihan, 56017, France
Le Mans Sarthe, 72037, France
Montivilliers Seine-Maritime, 76290, France
Amiens , 80054, France
Bourg-en- Bresse Cedex , 01012, France
Chalon sur Saone , 71100, France
Clamart , 92140, France
Dunkerque , 59240, France
Le Mans cedex 2 , 72015, France
Orleans , 45100, France
Perigueux , 24000, France
Poitiers , 86021, France
Rennes Cedex 9 , 35033, France
Rouen , 76038, France
Munchen Bayern, 81241, Germany
Dusseldorf , 40225, Germany
Hamburg , 22763, Germany
Tubingen , 72076, Germany
Patra Achaia, 26500, Greece
Alexandroupoli , 68100, Greece
Athens , 10676, Greece
Athens , 11528, Greece
Ioannina , 45500, Greece
Thessaloniki , 54007, Greece
Beer Sheva , 84001, Israel
Haifa , 31048, Israel
Haifa , 31096, Israel
Haifa , 34362, Israel
Jerusalem , 91120, Israel
Bologna Emilia-Romagna, 40138, Italy
Ravenna Emilia-Romagna, 48100, Italy
Reggio Emilia Emilia-Romagna, 42123, Italy
Rimini Emilia-Romagna, 47900, Italy
Pesaro Marche, 61122, Italy
Candiolo Piemonte, 10060, Italy
Orbassano Piemonte, 10043, Italy
Torino Piemonte, 10126, Italy
Rionero in Vulture PZ, , Italy
Aviano , 33081, Italy
Brescia , 25123, Italy
Meldola , 47014, Italy
Milano , 20122, Italy
Modena , 41100, Italy
Parma , 43100, Italy
Udine , 33100, Italy
Vicenza , 36100, Italy
Dordrecht Zuid-Holland, 3318 , Netherlands
Sittard , 6162 , Netherlands
Oslo Oppland, N-134, Norway
Bergen , N-502, Norway
Forde , 6812, Norway
Stavanger , N-401, Norway
Trondheim , N-700, Norway
Kirov , 61002, Russian Federation
Moscow , 11112, Russian Federation
Moscow , 12528, Russian Federation
Moscow , 12930, Russian Federation
Samara , 43302, Russian Federation
Madrid Madrid, Communidad Delaware, 28031, Spain
Girona , 17007, Spain
Valencia , 46010, Spain
Helsingborg Skane Lan, SE-25, Sweden
Boras , SE-50, Sweden
Umea , 901 8, Sweden
Ankara , 06200, Turkey
Ankara , 06500, Turkey
Ankara , 06590, Turkey
Izmir , 35340, Turkey
Izmir , , Turkey
Kayseri , 38039, Turkey
Truro Cornwall, TR1 3, United Kingdom
Bodelwyddan Denbighshire-SirDdinbych, LL18 , United Kingdom
Bournemouth Dorset, BH7 7, United Kingdom
Canterbury Kent, CT1 3, United Kingdom
Oxford Oxfordshire, OX4 6, United Kingdom
Stoke-on-Trent Staffordshire, ST4 6, United Kingdom
Leicester , LE1 5, United Kingdom
Swansea , SA2 8, United Kingdom
Wolverhampton , WV10 , United Kingdom
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