A Study of Ixazomib, Given With Dexamethasone in Adults With Multiple Myeloma

• ClinicalTrials.gov Identifier: NCT03170882
• Recruitment Status: Completed
• First Posted: May 31, 2017
• Results First Posted: October 27, 2021
• Last Update Posted: December 20, 2022
• Sponsor: Millennium Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Takeda ( Millennium Pharmaceuticals, Inc. )

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Relapsed and/or Refractory Multiple Myeloma	Drug: Ixazomib; Drug: Pomalidomide; Drug: Dexamethasone	Phase 2

Detailed Description:

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 122 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Randomized, Open-Label Study Comparing Oral Ixazomib/Dexamethasone and Oral Pomalidomide/Dexamethasone in Relapsed and/or Refractory Multiple Myeloma
• Actual Study Start Date: August 1, 2017
• Actual Primary Completion Date: August 1, 2020
• Actual Study Completion Date: November 26, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Pomalidomide 4 mg + Dexamethasone 40 mg; Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged >=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.	Drug: Pomalidomide; Pomalidomide capsules; Drug: Dexamethasone; Dexamethasone tablets
Experimental: Ixazomib 4 mg + Dexamethasone 20 mg; Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged >=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.	Drug: Ixazomib; Ixazomib capsules; Other Names: NINLARO; MLN9708; Drug: Dexamethasone; Dexamethasone tablets

Outcome Measures

Primary Outcome Measures :

1. Progression Free Survival (PFS) [ Time Frame: From date of randomization until first occurrence of confirmed disease progression or death due to any cause, whichever occurs first (Up to approximately 3 years) ]
   PFS: Time from randomization to first occurrence of confirmed progressive disease (PD) as assessed by investigator by International Myeloma Working Group(IMWG) response criteria/death from any cause, whichever occurs first. PD requires following: Increase of >=25 % from nadir in: Serum M component (increase must be >=0.5 gram per deciliter [g/dl]); Urine M-component (increase must be >=200 milligram [mg]/24-hour); In participants without measurable serum and urine M-protein levels difference between involved and uninvolved free light chain (FLC) increase of >10 mg/dl; In participants without measurable serum and urine M protein levels and without measurable disease by FLC level: bone marrow plasma cell percentage must be >=10%; Development of new/increase in size of existing bone lesions/soft tissue plasmacytomas; development of hypercalcemia (>11.5mg/dL corrected serum calcium) attributed solely to plasma cell proliferative disease.

Secondary Outcome Measures :

1. Overall Survival (OS) [ Time Frame: From date of randomization to death due to any cause (Up to approximately 3 years) ]
   OS was defined as the time from randomization to death from any cause, up to 3 years are reported.
2. Percentage of Participants With Overall Response [ Time Frame: From date of randomization until first documentation of CR, VGPR or PR (Up to approximately 3 years) ]
   Overall Response Rate (ORR) was defined as the percentage of participants who achieved partial response (PR), very good partial response (VGPR), or complete response (CR) based on laboratory results and IRC assessment using modified IMWG criteria. PR: >=50% reduction of serum M protein + reduction in 24-hour urinary M protein by >=90% or to <200 mg/24-hour; if M protein is not measurable, >=50% decrease in difference between involved and uninvolved FLC levels is required; if not measurable by FLC, >=50% reduction in bone marrow plasma cells, when baseline value >=30% and; if present at baseline, >=50% reduction in size of soft tissue plasmacytomas is required. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein + urine M-protein level <100 mg/24-hour. CR: negative immunofixation on serum + urine; disappearance of soft tissue plasmacytomas; <5 % plasma cells in bone marrow.
3. Duration of Response (DOR) [ Time Frame: From date of first documentation of CR, VGPR or PR until first occurrence of confirmed disease progression or death due to any cause, whichever occurs first (Up to approximately 3 years) ]
   DOR: Time from first documentation of CR/PR/VGPR to first documentation of PD. Per IMWG criteria, PR:>=50% reduction of serum M protein+reduction in 24-hour urinary M protein by >=90% to <200 mg/24-hour or >=50% decrease in difference between involved and uninvolved FLC levels/ >=50% reduction in bone marrow plasma cells, if >=30% at Baseline/ >=50% reduction in size of soft tissue plasmacytomas. VGPR: serum+urine M-protein detectable by immunofixation but not on electrophoresis/ >=90% reduction in serum M-protein + urine M-protein level <100 mg/24-hour. CR:negative immunofixation on serum + urine+disappearance of soft tissue plasmacytomas+<5% plasma cells in bone marrow. PD:serum M-component increase >=0.5 g/dl or urine M-component increase >=200 mg/24-hour/ difference between involved and uninvolved FLC levels increase >10 mg/dl or bone marrow plasma cell >=10%/development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia.
4. Time to Response [ Time Frame: From date of randomization until first documentation of CR, VGPR or PR (Up to approximately 3 years) ]
   Time to response was defined as the time from randomization to the first documentation of PR/VGPR/CR. Per IMWG criteria, PR: >=50% reduction of serum M protein + reduction in 24-hour urinary M protein by >=90% or to <200 mg/24-hour; if M-protein is not measurable, >=50% decrease in difference between involved and uninvolved FLC levels is required; if not measurable by FLC, >=50% reduction in bone marrow plasma cells, when Baseline value >=30% and; if present at Baseline, >=50% reduction in size of soft tissue plasmacytomas is required. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein + urine M-protein level <100 mg/24-hour. CR: negative immunofixation on serum + urine; disappearance of soft tissue plasmacytomas; <5% plasma cells in bone marrow.
5. Time to Progression (TTP) [ Time Frame: From date of randomization until first occurrence of confirmed disease progression or death due to any cause, whichever occurs first (Up to approximately 3 years) ]
   TTP was defined as the time from the date of randomization to first documentation of PD. Per IMWG criteria, PD required 1 of the following: Increase of >=25% from nadir in: Serum M-component (increase must be >=0.5 g/dl; Urine M-component (increase must be >=200 mg/24-hour); In participants without measurable serum and urine M-protein levels difference between involved and uninvolved FLC levels increase of >10 mg/dl; In participants without measurable serum and urine M protein levels and without measurable disease by FLC level: Bone marrow plasma cell percentage must be >=10%; Development of new or increase in size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (>11.5 mg/dL corrected serum calcium) attributed solely to plasma cell proliferative disease.
6. Health-Related Quality of Life (HRQOL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30 (EORTC QLQ-C30) Physical Domain Score [ Time Frame: Baseline and End of Treatment (Up to 28 cycles, each cycle was of 28 days) ]
   The EORTC QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/quality of life (QOL) scale. The physical domain consisted of 5 items covering participant's daily physical activities on a scale from 1 (not at all) to 4 (very much). Raw scores were linearly transformed to a total score between 0-100, with a high score indicating better physical functioning.
7. HRQOL Based on EORTC QLQ-C30 SubScale Score [ Time Frame: Baseline and End of Treatment (Up to 28 cycles, each cycle was of 28 days) ]
   The EORTC QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a QOL scale. Most of the 30 items had 4 response levels (not at all, a little, quite a bit, and very much), with 2 questions relying on a 7-point numeric rating scale. Each subscale raw score were linearly transformed to a total score between 0 to 100. For the functional scales and the global health status/QOL scale, higher scores represent better QOL; for the symptom scales, lower scores represent better QOL. The Physical domain of the functional subscale is reported in the secondary outcome measure 7.
8. HRQOL Based on EORTC Multiple Myeloma Module 20 (EORTC QLQ-MY20) Score [ Time Frame: Baseline and End of Treatment (Up to 28 cycles, each cycle was of 28 days) ]
   The EORTC QLQ-MY20 has 20 items across 4 independent subscales, 2 symptoms scales (disease symptoms, side effects of treatment), and 2 functional subscales (body image, future perspective). Scores were averaged and transformed to 0-100 scale. Higher scores for the future perspective scale indicate better perspective of the future, for the body image scale indicate better body image and for the disease symptoms scale indicate higher level of symptomatology.
9. Number of Participants With Responses to HRQOL Based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score [ Time Frame: End of Treatment (Up to 28 cycles, each cycle was of 28 days) ]
   EQ-5D-5L comprises of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, 5= extremely severe problems. Higher scores indicated greater levels of problems across the five dimensions.
10. HRQOL Based on EuroQol Visual Analogue Scale (EQ VAS) Score [ Time Frame: Baseline and End of Treatment (Up to 28 cycles, each cycle was of 28 days) ]
    The EQ VAS records the respondent's self-rated health on a 20 centimeter (cm), vertical, visual analogue scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores from all dimensions were combined into a single index score that was reported, where higher score was better quality of life.
11. Health Care Utilization (HU): Number of Participants With at Least One Medical Encounter [ Time Frame: Up to approximately 3 years ]
    Healthcare resources used during medical encounters included hospitalizations, emergency room stays, or outpatient visits. A hospitalization was defined as at least 1 overnight stay in an Intensive Care Unit and/or non-Intensive Care Unit (acute care unit, palliative care unit, and hospice).
12. HU: Duration of Medical Encounters [ Time Frame: Up to approximately 3 years ]
    Duration of healthcare resources used during medical encounters including hospitalizations, emergency room stays, or outpatient visits was reported in days. A hospitalization was defined as at least 1 overnight stay in an Intensive Care Unit and/or non-Intensive Care Unit (acute care unit, palliative care unit, and hospice).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Must have a confirmed diagnosis of multiple myeloma (MM) requiring therapy according to International Myeloma Working Group (IMWG) criteria.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
3. 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.
4. 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.

5. 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.

6. 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).
7. Suitable venous access for the study-required blood sampling, including pharmacokinetic (PK) sampling.
8. Recovered (that is, less than or equal to [<=] Grade 1 nonhematologic toxicity) from the reversible effects of prior anticancer therapy.
9. 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).

Exclusion Criteria:

1. 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.
2. 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.
3. 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.
4. Peripheral neuropathy Grade 1 with pain or Grade 2 or higher peripheral neuropathy of any cause on clinical examination during the Screening period.
5. 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.
6. Known gastrointestinal disease or gastrointestinal procedure that could interfere with the oral absorption or tolerance of study therapy, including difficulty swallowing.
7. Serious infection requiring parenteral antibiotic therapy or any other serious infection within 14 days before randomization.
8. Central nervous system involvement with MM (by clinical symptoms and signs).
9. 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.
10. 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.
11. Admission or evidence of illicit drug use, drug abuse, or alcohol abuse.
12. 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.

Contacts and Locations

Locations

United States, Arkansas

Highlands Oncology Group

Fayetteville, Arkansas, United States, 72703

United States, California

St Joseph Heritage Healthcare

Santa Rosa, California, United States, 95403

United States, Florida

Lynn Cancer Institute

Boca Raton, Florida, United States, 33486

University of Florida

Gainesville, Florida, United States, 32610

United States, Maryland

University of Maryland

Baltimore, Maryland, United States, 21201

United States, Michigan

Henry Ford Health System

Detroit, Michigan, United States, 48202

Michigan State University

Lansing, Michigan, United States, 48910

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

United States, New Mexico

San Juan Oncology Associates

Farmington, New Mexico, United States, 87401

United States, Ohio

University of Toledo Medical Center

Toledo, Ohio, United States, 43614

Australia, Queensland

Icon Cancer Care South Brisbane

South Brisbane, Queensland, Australia, 4101

Australia, South Australia

The Queen Elizabeth Hospital

Woodville South, South Australia, Australia, 5011

Australia, Victoria

Box Hill Hospital

Box Hill, Victoria, Australia, 3128

St Vincents Hospital Melbourne

Fitzroy, Victoria, Australia, 3065

Australia

Royal Adelaide Hospital

Adelaide, Australia

Belgium

GasthuisZusters Antwerpen

Wilrijk, Antwerpen, Belgium, 2610

AZ St Jan Brugge Oostende AV

Brugge, Belgium, 8000

Canada, Ontario

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada, L4M 6M2

Lakeridge Health Center

Ottawa, Ontario, Canada, L1G 2B9

Czechia

Fakultni nemocnice Hradec Kralove

Hradec Kralove, Kralovehradeck Kraj, Czechia, 500 05

University Hospital Olomouc

Olomouc, Olomouck Kraj, Czechia, 775 20

Fakultni nemocnice Kralovske Vinohrady

Prague, Praha, Hlavni Mesto, Czechia, 100 34

Vseobecna fakultni nemocnice v Praze

Praha, Praha, Hlavni Mesto, Czechia, 128 08

Fakultni nemocnice Brno

Brno, Czechia, 625 00

Fakultni nemocnice Ostrava

Ostrava, Czechia

Fakultni nemocnice Plzen

Plzen Lochotin, Czechia, 304 60

Denmark

Aalborg Universitetshospital

Aalborg, Nordjylland, Denmark, 9100

Regionshospitalet Holstebro

Holstebro, Denmark, 7500

France

Centre Antoine Lacassagne Centre Regional de Lutte Contre Le Cancer

Nice, Alpes-Maritimes, France, 06189

CHRU Dijon Complexe Du Bocage

Dijon, Cote-d'Or, France, 21034

CHRU de Brest - Hopital Morvan

Brest, Finistere, France, 29609

CHRU Nancy

Vandoeuvre Les Nancy, Meurthe-et-Moselle, France, 54511

Centre Hospitalier Bretagne Atlantique Vannes

Vannes, Morbihan, France, 56017

Centre Hospitalier Le Mans

Le Mans, Sarthe, France, 72037

Groupe Hospitalier du Havre

Montivilliers, Seine-Maritime, France, 76290

CHU Amiens Hopital Sud

Amiens, France, 80054

Centre Hospitalier Fleyriat

Bourg-en- Bresse Cedex, France, 01012

Centre Hospitalier (CH) William Morey

Chalon sur Saone, France, 71100

Hospital d Instructions des Armees Percy

Clamart, France, 92140

Centre Hospitalier de Dunkerque

Dunkerque, France, 59240

Centre Jean Bernard Clinique Victor Hugo

Le Mans cedex 2, France, 72015

Centre Hospitalier Regional d'Orleans

Orleans, France, 45100

Centre Hospitalier de Perigueux

Perigueux, France, 24000

CHRU de Poitiers La Miletrie

Poitiers, France, 86021

CHRU Rennes

Rennes Cedex 9, France, 35033

Centre Henri Becquerel

Rouen, France, 76038

Germany

Uberortliche Gemeinschaftspraxis Pasing und Furstenfeldbruck

Munchen, Bayern, Germany, 81241

Universitatsklinikum Dusseldorf

Dusseldorf, Germany, 40225

Asklepios Klinik Altona

Hamburg, Germany, 22763

Universitatsklinikum Tubingen

Tubingen, Germany, 72076

Greece

University General Hospital of Patras

Patra, Achaia, Greece, 26500

University Hospital of Alexandroupolis

Alexandroupoli, Greece, 68100

Evangelismos General Hospital of Athens

Athens, Greece, 10676

Alexandra Hospital

Athens, Greece, 11528

University General Hospital of Ioannina

Ioannina, Greece, 45500

Theageneio Anticancer Oncology Hospital of Thessaloniki

Thessaloniki, Greece, 54007

Israel

Soroka University Medical Centre

Beer Sheva, Israel, 84001

Bnai Zion Medical Center

Haifa, Israel, 31048

Rambam Health Corporation

Haifa, Israel, 31096

Lady Davis Carmel Medical Center

Haifa, Israel, 34362

Hadassah Medical Center

Jerusalem, Israel, 91120

Italy

Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

Bologna, Emilia-Romagna, Italy, 40138

Ospedale Santa Maria Delle Croci

Ravenna, Emilia-Romagna, Italy, 48100

Arcispedale Santa Maria Nuova

Reggio Emilia, Emilia-Romagna, Italy, 42123

Ospedale Infermi di Rimini

Rimini, Emilia-Romagna, Italy, 47900

Azienda Ospedaliera Ospedali Riuniti Marche Nord

Pesaro, Marche, Italy, 61122

Fondazione del Piemonte per lOncologia (IRCCS)

Candiolo, Piemonte, Italy, 10060

Azienda Sanitaria Ospedaliera S Luigi Gonzaga

Orbassano, Piemonte, Italy, 10043

Azienda Ospedaliera Citta della Salute e della Scienza di Torino

Torino, Piemonte, Italy, 10126

Centro Di Riferimento Oncologico Della Basilicata

Rionero in Vulture, PZ, Italy

Centro Di Riferimento Oncologico

Aviano, Italy, 33081

ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia

Brescia, Italy, 25123

Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST

Meldola, Italy, 47014

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milano, Italy, 20122

Azienda Ospedaliero Universitaria Di Modena Policlinico

Modena, Italy, 41100

Azienda Ospedaliero Universitaria di Parma

Parma, Italy, 43100

Ospedale Santa Maria Della Misericordia

Udine, Italy, 33100

Azienda ULSS 6 Vicenza

Vicenza, Italy, 36100

Netherlands

Albert Schweitzer Ziekenhuis

Dordrecht, Zuid-Holland, Netherlands, 3318 AT

Zuyderland Medisch Centrum

Sittard, Netherlands, 6162 BG

Norway

Oslo Universitetssykehus HF Rikshospitalet

Oslo, Oppland, Norway, N-1346

Haukeland Universitetssykehus

Bergen, Norway, N-5021

Forde Sentralsjukehus

Forde, Norway, 6812

Stavanger Universitetssykehus

Stavanger, Norway, N-4011

St Olavs Hospital

Trondheim, Norway, N-7006

Russian Federation

Kirov Research Institute of Haematology and Blood Transfusion

Kirov, Russian Federation, 610027

Moscow Clinical Scientific Center

Moscow, Russian Federation, 111123

City Clinical Hospital n a S P Botkin

Moscow, Russian Federation, 125284

City Clinical Hospital # 40

Moscow, Russian Federation, 129301

Samara State Medical University

Samara, Russian Federation, 433021

Spain

Hospital Universitario Infanta Leonor

Madrid, Madrid, Communidad Delaware, Spain, 28031

Hospital Universitari de Girona Dr Josep Trueta

Girona, Spain, 17007

Hospital Clinico Universitario de Valencia

Valencia, Spain, 46010

Sweden

Helsingborg Lasarett

Helsingborg, Skane Lan, Sweden, SE-25187

Sodra Alvsborgs Sjukhus Boras

Boras, Sweden, SE-50182

Norrlands Universitetssjukhus

Umea, Sweden, 901 85

Turkey

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

Ankara, Turkey, 06200

Gazi University Medical Faculty Gazi Hospital

Ankara, Turkey, 06500

Ankara University Medical Faculty Cebeci Hospital

Ankara, Turkey, 06590

Dokuz Eylul University Medical Faculty

Izmir, Turkey, 35340

Ege Universitesi Tip Fakultesi Hastanesi

Izmir, Turkey

Erciyes Universitesi Tip Fakultesi Hastanesi

Kayseri, Turkey, 38039

United Kingdom

Royal Cornwall Hospital

Truro, Cornwall, United Kingdom, TR1 3LJ

Betsi Cadwaladr University Health Board

Bodelwyddan, Denbighshire-SirDdinbych, United Kingdom, LL18 5UJ

Royal Bournemouth Hospital

Bournemouth, Dorset, United Kingdom, BH7 7DW

Kent and Canterbury Hospital

Canterbury, Kent, United Kingdom, CT1 3NG

GenesisCare Oxford

Oxford, Oxfordshire, United Kingdom, OX4 6LB

Royal Stoke University Hospital

Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG

Leicester Royal Infirmary

Leicester, United Kingdom, LE1 5WW

Singleton Hospital

Swansea, United Kingdom, SA2 8QA

New Cross Hospital

Wolverhampton, United Kingdom, WV10 0QP

Sponsors and Collaborators

Millennium Pharmaceuticals, Inc.

Investigators

• Study Director: Medical Director; Takeda

  Study Documents (Full-Text)

Documents provided by Takeda ( Millennium Pharmaceuticals, Inc. ):

Study Protocol  [PDF] August 31, 2020

Statistical Analysis Plan  [PDF] November 11, 2019

More Information

Additional Information:

Related Info 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Dimopoulos MA, Schjesvold F, Doronin V, Vinogradova O, Quach H, Leleu X, Montes YG, Ramasamy K, Pompa A, Levin MD, Lee C, Mellqvist UH, Fenk R, Demarquette H, Sati H, Vorog A, Labotka R, Du J, Darif M, Kumar S. Oral ixazomib-dexamethasone vs oral pomalidomide-dexamethasone for lenalidomide-refractory, proteasome inhibitor-exposed multiple myeloma: a randomized Phase 2 trial. Blood Cancer J. 2022 Jan 24;12(1):9. doi: 10.1038/s41408-021-00593-2.

• Responsible Party: Millennium Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT03170882
• Other Study ID Numbers: C16029; 2016-004742-28 ( EudraCT Number ); U1111-1188-2677 ( Other Identifier: WHO ); 2017/1235 ( Registry Identifier: Norwegian Medicines Agency ); N-20170083 ( Registry Identifier: Danish Medicines Agency ); 17/NW/0546 ( Registry Identifier: NRES )
• First Posted: May 31, 2017
• Results First Posted: October 27, 2021
• Last Update Posted: December 20, 2022
• Last Verified: November 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• URL: https://vivli.org/ourmember/takeda/

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Takeda ( Millennium Pharmaceuticals, Inc. ):

Drug therapy

Additional relevant MeSH terms:

Multiple Myeloma; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Dexamethasone; Pomalidomide; Ixazomib; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Immunologic Factors; Angiogenesis Inhibitors