Clinical trial · Interventional
Phase 1 Pharmacokinetic Study of Oral Ixazomib Plus Lenalidomide and Dexamethasone in Adult Asian Participants With Relapsed and/or Refractory Multiple Myeloma
A Phase 1 Pharmacokinetic and Tolerability Study of Oral MLN9708 Plus Lenalidomide and Dexamethasone in Adult Asian Patients With Relapsed and/or Refractory Multiple Myeloma
NCT01645930CI-TRIAL-00035698completedPhase 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)
The purpose of this Phase 1 study is to characterize the pharmacokinetic (PK) and tolerability of oral ixazomib (MLN9708) when administered in combination with lenalidomide and dexamethasone in adult Asian 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 |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Ixazomib | Drug | Ixazomib | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ixazomib+Lenalidomide+Dexamethasone
- description
- Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles)
- interventionNames
- Drug: Ixazomib
- Drug: Lenalidomide
- Drug: Dexamethasone
Primary outcomes (10)
- measure
- Cmax: Maximum Observed Plasma Concentration for Ixazomib
- timeFrame
- Cycle 1, Day 1 pre-dose and multiple time-points (up to 168 hours) post-dose
- measure
- Cmax: Maximum Observed Plasma Concentration for Ixazomib
- timeFrame
- Cycle 1, Day 15 pre-dose and multiple time-points (up to 336 hours) post-dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female East Asian participants 18 years or older * Diagnosed Multiple Myeloma according to standard criteria * Measurable disease as specified in study protocol * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * Participants with relapsed and/or refractory Multiple Myeloma who have received 1 to 3 prior therapies * Meet the clinical laboratories criteria as specified in the protocol * Female participants who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to abstain from heterosexual intercourse; must also adhere to the guidelines of the lenalidomide pregnancy prevention program * Male participants who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse and must adhere to the guidelines of the lenalidomide pregnancy prevention program * Must be able to take concurrent aspirin 325 mg daily * Voluntary written consent Exclusion Criteria: * Female participants who are lactating or pregnant * Major surgery or radiotherapy within 14 days before enrollment * Infection requiring systematic antibiotics within 14 days before study enrollment * Central nervous system involvement * Failure to have fully recovered from the effects of prior chemotherapy regardless of the interval since last treatment * Systemic treatment with strong inhibitors of cytochrome P450 1A2 (CYP1A2), strong inhibitors of CYP3A, or strong CYP3A inducers, or use of Ginko biloba or St. John's wort within 14 days before study enrollment * Diagnosis of Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome * Evidence of current uncontrolled cardiovascular conditions * Serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol * Known allergy to any of the study medications * Known gastrointestinal condition or procedure that could interfere with swallowing or the oral absorption of tolerance of ixazomib * Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease with the exception of nonmelanoma skin cancer or any completely resected carcinoma in situ * Ongoing or active systemic infection, active hepatitis B virus infect, active hepatitis C infection, or known human immunodeficiency virus (HIV) positive
References
Publications (1)
- DERIVEDGupta N, Goh YT, Min CK, Lee JH, Kim K, Wong RS, Chim CS, Hanley MJ, Yang H, Venkatakrishnan K, Hui AM, Esseltine DL, Chng WJ. Pharmacokinetics and safety of ixazomib plus lenalidomide-dexamethasone in Asian patients with relapsed/refractory myeloma: a phase 1 study. J Hematol Oncol. 2015 Sep 4;8:103. doi: 10.1186/s13045-015-0198-1. PMID 26337806