Phase 1
Completed N=43
Phase 1 Pharmacokinetic Study of Oral Ixazomib Plus Lenalidomide and Dexamethasone in Adult Asian Participants With Relapsed and/or Refractory Multiple Myeloma
Source: ClinicalTrials.gov NCT01645930 ↗Enrolled (actual)
43
Serious AEs
41.9%
Results posted
Nov 2018
Primary outcomePrimary: Cmax: Maximum Observed Plasma Concentration for Ixazomib — 37.57 ng/mL
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax: Maximum Observed Plasma Concentration for Ixazomib |
57.57 | — |
| PRIMARY Cmax: Maximum Observed Plasma Concentration for Ixazomib |
57.57 | — |
| PRIMARY Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib |
2.0 | — |
| PRIMARY Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib |
2.0 | — |
| PRIMARY AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for Ixazomib |
1746.0 | — |
| PRIMARY AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for Ixazomib |
1746.0 | — |
| PRIMARY Number of Participants With Dose Limiting Toxicities (DLTs) |
2 | — |
| PRIMARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
43; 18 | — |
| PRIMARY Number of Participants With Clinically Significant Laboratory Abnormalities Reported as Adverse Events of ≥Grade 3 Intensity |
2; 1; 1; 1; 2; 4 | — |
| PRIMARY Number of Participants With Clinically Significant Vital Signs Reported as Adverse Events |
4; 1 | — |
| SECONDARY Percentage of Participants With Confirmed Best Response Category |
53.5 | — |
| SECONDARY Duration of Response (DOR) |
12.9 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01645930). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.