Multiple MyelomaPhase 2IDEALLNCT03608501
A Study of Ixazomib, Thalidomide and Dexamethasone in Newly Diagnosed and Treatment-naive Multiple Myeloma (MM) Participants Non-eligible for Autologous Stem-cell Transplantation
A Phase 2 study testing Ixazomib, Thalidomide and Dexamethasone in people with Multiple Myeloma, run by Takeda at 6 sites in Brazil.
Trial summary
The primary purpose of this study is to determine the overall response rate (ORR) during induction therapy with the combination of ixazomib, thalidomide and low-dose dexamethasone in specific time points. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Ixazomib, Thalidomide and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 6 sitesBrazil
- Study dates
- 30 Sep 2019to 31 May 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clonal bone marrow plasma cells >=10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following myeloma defining events:
- Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically:
- Hypercalcaemia: serum calcium greater than (>) 1 mg/dL higher than the upper limit of normal (ULN) or >11 mg/dL;
- Renal insufficiency: creatinine clearance <40 milliliter (mL) per minute (as per validated equations) or serum creatinine >2 mg/dL;
- Anemia: haemoglobin value of >20 gram per liter (g/L) below the lower limit of normal, or a haemoglobin value <100 g/L;
- Bone lesions: one or more osteolytic lesions on skeletal radiography, computed tomography (CT), or positron emission tomography (PET)-CT.
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- Any one or more of the following biomarkers of malignancy:
- Clonal bone marrow plasma cell percentage >=60%.
- Involved: uninvolved serum free light chain ratio >=100.
- Greater than (>) 1 focal lesions on magnetic resonance imaging (MRI) studies. Note: clonality should be established by showing kappa to lambda ratio (κ/λ)-light-chain restriction on flow cytometry, immunohistochemistry, or immunofluorescence. Bone marrow plasma cell percentage should preferably be estimated from a core biopsy specimen; in case of a disparity between the aspirate and core biopsy, the highest value should be used.
- Ineligibility to autologous transplantation, as per investigator's discretion, regardless of age (the reason for such ineligibility should be recorded on the electronic case report form [eCRF]).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Ability to take concurrent aspirin daily (or enoxaparin subcutaneously daily), per published standard or institutional standard of care, as prophylactic anticoagulation.
- Note: For participants with prior history of deep vein thrombosis (DVT), low molecular weight heparin (LMWH) is mandatory.
- Left ventricular ejection fraction (LVEF) >=50%.
- Clinical laboratory values as specified below within 7 days before the first dose of study drug:
- Absolute neutrophil count (ANC) >=1,500 per cubic millimeter (/mm^3), unless related to bone marrow infiltration by malignant plasma cells.
- Hemoglobin >=8.0 g/dL
- Platelet count >=75,000/mm^3, unless related to bone marrow infiltration by malignant plasma cells (platelet transfusions to help participants meet eligibility criteria are not allowed).
- Aspartate aminotransferase (AST) and alanine aminotransferase (AST) less than or equal to (<=) 1.5 times the institutional ULN.
- Bilirubin <=1.5 mg/dL (or <=2.5 mg/dL in case of Gilbert-Meulengracht syndrome).
- Glomerular filtration rate >=30 milliliter per minute per (mL/min/) 1.73 square meter (m^2) according to the Modification of Diet in Renal Disease (MDRD) study abbreviated formula. If not on target, this evaluation may be repeated once after at least 24 hours.
- Prothrombin time (PT) or activated partial thromboplastin time (aPTT) within normal limits.
Who cannot join
- Presence of non-secretory or oligo-secretory myeloma, smoldering MM, monoclonal gammopathy of undetermined significance, plasma-cell leukemia, Waldenstrom's macroglobulinemia, primary amyloidosis, or polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes (POEMS) syndrome.
- Central nervous system involvement by MM.
- Prior radiation therapy involving an estimated >=25% of the hematopoietically active bone marrow. Radiotherapy should not be given within 14 days before enrollment. In case of palliative radiotherapy for pain control and if the involved field is small, 7 days will be considered a sufficient interval between the radiation treatment and administration of the study drugs.
- Treatment with any investigational products within 1 (one) year before the first dose of the study drug regimen.
- Presence of peripheral neuropathy of grade 1 with pain or grade 2 or higher.
- Previous or concurrent history of malignancies other than MM except for curatively treated cervical carcinoma in situ, non-melanoma skin cancer, superficial bladder cancer (Ta [non-invasive tumor], Tis [carcinoma in situ] and T1 [tumor invades lamina propria]), or localized prostate cancer.
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- With evidence or history of bleeding diathesis. Any hemorrhage or bleeding event >=common terminology criteria for adverse events (CTCAE) Grade 3 within 4 weeks of start of study medication.
- Major surgery within 14 days before randomization.
- Non-healing wound or ulcer.
- Seizure disorder requiring medication.
- Systemic treatment with strong cytochrome P-450 3A (CYP3A) inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort from Day-14 of cycle 1 until the safety follow-up.
- Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before the start of study medication.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Brazil6 sites
Universidade Estadual de Campinas UNICAMP - HEMOCENTRO
Campinas, São Paulo, 13083-878
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003
Instituto COI de Educacao e Pesquisa
Rio de Janeiro, Rio de Janeiro, 22793-080
CEHON Centro de Hematologia e Oncologia da Bahia
Salvador, Estado de Bahia, 40110-090
Clinica Medica Sao Germano S/S Ltda.
São Paulo, São Paulo, 04537-080
Hospital das Clinicas da Faculdade de Medicina da USP
São Paulo, São Paulo, 05403-010
About this study
Official title: An Open-Label, Single-Arm Phase II Study of Ixazomib, Thalidomide and Dexamethasone in Newly Diagnosed and Treatment-Naive Multiple Myeloma Patients Non-Eligible for Autologous Stem-Cell Transplantation
The primary purpose of this study is to determine the overall response rate (ORR) during induction therapy with the combination of ixazomib, thalidomide and low-dose dexamethasone in specific time points.
Read the detailed description
The drugs being tested in this study are a combination therapy of ixazomib, thalidomide and low-dose dexamethasone. This combination therapy is being tested to treat people who are newly diagnosed with multiple myeloma and non-eligible to autologous stem cell transplantation (ASCT). This study will assess the ORR during induction therapy in specific timepoints.
The study will enroll approximately 40 participants. All participants will receive:
Ixazomib citrate 4 mg + Thalidomide 100 mg and Dexamethasone 40 mg.
All participants will be asked to take their study medication at approximately the same time each day.
This multi-center trial will be conducted in Brazil. The overall time to participate in this study is approximately 5 years. Participants will make multiple visits to the clinic, and will be contacted by telephone or will make a final visit 30 days after receiving their last dose of drug or resolution of serious adverse event (SAE), whichever occurs later for a follow-up assessment.
- Conditions
- Multiple Myeloma
- Being tested
- Ixazomib, Thalidomide, Dexamethasone
- Keywords
- Drug therapy
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IxazomibDrug
Also called Ixazomib citrate
Ixazomib capsules.
ThalidomideDrug
Thalidomide capsules.
DexamethasoneDrug
Dexamethasone tablets.
| Study group | Role | What they receive |
|---|---|---|
| Ixazomib 4 mg + Thalidomide 100 mg + Dexamethasone 40 mg | Experimental | Ixazomib 4 milligram (mg), capsule, orally, once on Days 1, 8 and 15 along with thalidomide 100 mg, tablet, orally, once daily and dexamethasone 40 mg, tablet, orally, once on Days 1, 8, 15 and 22 in a 28-day treatment cycle for up to 9 cycles or until withdrawal from the study in the treatment phase. Participants who complete treatment phase will be eligible to continue on to the maintenance phase of the study to receive ixazomib 4 mg, capsules, orally, once on Days 1, 8 and 15 of a 28-day treatment cycle for up to 24 months or until withdrawal from the study. Receives: Drug: Ixazomib; Drug: Thalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR During Induction
ORR is the percentage of participants with presence of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). ORR assessment will be based on International Myeloma Working Group (IMWG) response criteria.
Measured: Upon ORR assessment during specific timepoints for all participants completing or withdrawn prematurely from the induction phase (Baseline up to approximately 9 month [Cycle 9])
Secondary outcomes (4)
Progression-free Survival (PFS)
PFS is the time elapsed between treatment initiation and first PD documentation or death from any cause, where PD is assessed by IMWG response criteria.
Measured: Upon study termination (Baseline up to first documentation of disease progression [PD] or death from any cause [approximately 2 years])
ORR During Maintenance
ORR is the percentage of participants with presence of sCR, CR, VGPR or PR. ORR assessment will be based on IMWG response criteria.
Measured: Upon ORR assessment during specific time points for all participants completing or withdrawn prematurely from maintenance phase (Baseline up to approximately 2 years)
Overall Survival (OS)
OS is defined as the time elapsed between treatment initiation and death from any cause.
Measured: Upon study termination (Baseline up to approximately 5 years)
Time to Response During Induction
Time to response is the time elapsed between treatment initiation and the first documentation of sCR, VGPR or PR according to the IMWG response criteria.
Measured: End of induction phase (Baseline up to approximately 9 months [Cycle 9])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start30 Sep 2019 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion31 May 2023 (estimated)
Why it stopped: Business decision (no safety or efficacy concerns)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608501
- Sponsor's protocol ID
- C16041
- Other IDs
- U1111-1214-1078
- Acronym
- IDEALL
- Status last verified
- Jan 2020
- First submitted
- 11 Jul 2018
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm Phase II Study of Ixazomib, Thalidomide and Dexamethasone in Newly Diagnosed and Treatment-Naive Multiple Myeloma Patients Non-Eligible for Autologous Stem-Cell Transplantation
- ClinicalTrials.gov ID
- NCT03608501
- Acronym / sponsor ID
- IDEALL / C16041
- Conditions
- Multiple Myeloma
- Keywords
- Drug therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision (no safety or efficacy concerns)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2019 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 1 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to determine the overall response rate (ORR) during induction therapy with the combination of ixazomib, thalidomide and low-dose dexamethasone in specific time points.
Detailed description
The drugs being tested in this study are a combination therapy of ixazomib, thalidomide and low-dose dexamethasone. This combination therapy is being tested to treat people who are newly diagnosed with multiple myeloma and non-eligible to autologous stem cell transplantation (ASCT). This study will assess the ORR during induction therapy in specific timepoints.
The study will enroll approximately 40 participants. All participants will receive:
Ixazomib citrate 4 mg + Thalidomide 100 mg and Dexamethasone 40 mg.
All participants will be asked to take their study medication at approximately the same time each day.
This multi-center trial will be conducted in Brazil. The overall time to participate in this study is approximately 5 years. Participants will make multiple visits to the clinic, and will be contacted by telephone or will make a final visit 30 days after receiving their last dose of drug or resolution of serious adverse event (SAE), whichever occurs later for a follow-up assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ixazomib 4 mg + Thalidomide 100 mg + Dexamethasone 40 mg | Experimental | Drug: Ixazomib, Drug: Thalidomide, Drug: DexamethasoneIxazomib 4 milligram (mg), capsule, orally, once on Days 1, 8 and 15 along with thalidomide 100 mg, tablet, orally, once daily and dexamethasone 40 mg, tablet, orally, once on Days 1, 8, 15 and 22 in a 28-day treatment cycle for up to 9 cycles or until withdrawal from the study in the treatment phase. Participants who complete treatment phase will be eligible to continue on to the maintenance phase of the study to receive ixazomib 4 mg, capsules, orally, once on Days 1, 8 and 15 of a 28-day treatment cycle for up to 24 months or until withdrawal from the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Clonal bone marrow plasma cells >=10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following myeloma defining events:
- Ineligibility to autologous transplantation, as per investigator's discretion, regardless of age (the reason for such ineligibility should be recorded on the electronic case report form [eCRF]).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Ability to take concurrent aspirin daily (or enoxaparin subcutaneously daily), per published standard or institutional standard of care, as prophylactic anticoagulation.
- Note: For participants with prior history of deep vein thrombosis (DVT), low molecular weight heparin (LMWH) is mandatory.
Key exclusion criteria (12 listed)
- Presence of non-secretory or oligo-secretory myeloma, smoldering MM, monoclonal gammopathy of undetermined significance, plasma-cell leukemia, Waldenstrom's macroglobulinemia, primary amyloidosis, or polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes (POEMS) syndrome.
- Central nervous system involvement by MM.
- Prior radiation therapy involving an estimated >=25% of the hematopoietically active bone marrow. Radiotherapy should not be given within 14 days before enrollment. In case of palliative radiotherapy for pain control and if the involved field is small, 7 days will be considered a sufficient interval between the radiation treatment and administration of the study drugs.
- Treatment with any investigational products within 1 (one) year before the first dose of the study drug regimen.
- Presence of peripheral neuropathy of grade 1 with pain or grade 2 or higher.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IxazomibAlso: Ixazomib citrateIxazomib capsules. | Drug | Ixazomib 4 mg + Thalidomide 100 mg + Dexamethasone 40 mg |
| ThalidomideThalidomide capsules. | Drug | Ixazomib 4 mg + Thalidomide 100 mg + Dexamethasone 40 mg |
| DexamethasoneDexamethasone tablets. | Drug | Ixazomib 4 mg + Thalidomide 100 mg + Dexamethasone 40 mg |
Primary outcome
ORR During Induction
Time frame: Upon ORR assessment during specific timepoints for all participants completing or withdrawn prematurely from the induction phase (Baseline up to approximately 9 month [Cycle 9])
ORR is the percentage of participants with presence of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). ORR assessment will be based on International Myeloma Working Group (IMWG) response criteria.
4 secondary outcomes
Progression-free Survival (PFS)
Time frame: Upon study termination (Baseline up to first documentation of disease progression [PD] or death from any cause [approximately 2 years])
ORR During Maintenance
Time frame: Upon ORR assessment during specific time points for all participants completing or withdrawn prematurely from maintenance phase (Baseline up to approximately 2 years)
Overall Survival (OS)
Time frame: Upon study termination (Baseline up to approximately 5 years)
Time to Response During Induction
Time frame: End of induction phase (Baseline up to approximately 9 months [Cycle 9])
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Individual participant dataSharing planned: Yes. Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Takeda
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ixazomib, Thalidomide and Dexamethasone in people with Multiple Myeloma, run by Takeda at 6 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR During Induction (time frame: Upon ORR assessment during specific timepoints for all participants completing or withdrawn prematurely from the induction phase (Baseline up to approximately 9 month [Cycle 9])). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.