Clinical trial · Interventional
Study of Oral Ixazomib in Adult Participants With Relapsed and/or Refractory (RR) Multiple Myeloma
An Open-Label, Dose-Escalation, Phase 1 Study of the Oral Form of Ixazomib (MLN9708), a Second-Generation Proteasome Inhibitor, in Adult Patients With Relapsed and/or Refractory Multiple Myeloma
NCT00932698CI-TRIAL-00039913completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will determine the safety profile, tolerability, and maximum tolerated dose (MTD) and disease response of Ixazomib administered orally in participants with relapsed and/or refractory multiple myeloma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed and Refractory Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ixazomib | Drug | Ixazomib | ALIAS |
Design
Arms and outcomes
Arms (11)
- type
- EXPERIMENTAL
- label
- Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2
- description
- Ixazomib 0.24 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 220 days).
- interventionNames
- Drug: Ixazomib
- type
- EXPERIMENTAL
- label
- Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2
- description
- Ixazomib 0.48 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 270 days).
- interventionNames
- Drug: Ixazomib
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Each participant must meet all of the following inclusion criteria to be enrolled in the study: * Multiple myeloma diagnosed according to the standard criteria. * Participants with multiple myeloma who have relapsed following at least 2 lines of therapy. * Participants must have measurable disease. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. * Female participants who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse. * Male participants who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse. * Voluntary written consent. * Suitable venous access for study-required blood sampling. Exclusion Criteria: Participants meeting any of the following exclusion criteria are not to be enrolled in the study: * Peripheral neuropathy greater than or equal to (\>=) Grade 2. * Female participants who are lactating or have a positive serum pregnancy test during the screening period. * Major surgery within 14 days before the first dose of study drug. * Infection requiring systemic antibiotic therapy or other serious infection within 14 days before the first dose of study treatment. * Life-threatening illness unrelated to cancer. * Diarrhea \> Grade 1, based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) categorization. * Systemic antineoplastic or radiation therapy within 14 days of cytotoxic agents within 21 days before the first dose of study treatment. * Treatment with any investigational products within 21 days before the first dose of study treatment. * Treatment with any investigational proteasome inhibitor. * Systemic treatment with prohibited medication. * Ongoing therapy with corticosteroids greater than 10mg of prednisone or its equivalent per day. Inhaled and topical steroids are permitted. * Central nervous system involvement. * Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within the past 6 months. * Corrected QT interval (QTc) \> 470 milliseconds on a 12-lead electrocardiogram (ECG) obtained during the screening period. * Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection. * Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol. * Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption of tolerance of ixazomib including difficulty swallowing.
References
Publications (2)
- DERIVEDGupta N, Yang H, Hanley MJ, Zhang S, Liu R, Kumar S, Richardson PG, Skacel T, Venkatakrishnan K. Dose and Schedule Selection of the Oral Proteasome Inhibitor Ixazomib in Relapsed/Refractory Multiple Myeloma: Clinical and Model-Based Analyses. Target Oncol. 2017 Oct;12(5):643-654. doi: 10.1007/s11523-017-0524-3. PMID 28803351
- DERIVEDRichardson PG, Baz R, Wang M, Jakubowiak AJ, Laubach JP, Harvey RD, Talpaz M, Berg D, Liu G, Yu J, Gupta N, Di Bacco A, Hui AM, Lonial S. Phase 1 study of twice-weekly ixazomib, an oral proteasome inhibitor, in relapsed/refractory multiple myeloma patients. Blood. 2014 Aug 14;124(7):1038-46. doi: 10.1182/blood-2014-01-548826. Epub 2014 Jun 11. PMID 24920586