Overview

This trial is active, not recruiting.

Condition multiple myeloma
Treatment ixazomib
Phase phase 1
Target proteasome
Sponsor Millennium Pharmaceuticals, Inc.
Start date December 2012
End date July 2019
Trial size 19 participants
Trial identifier NCT01645930, C16013

Summary

The purpose of this Phase 1 study is to characterize the Pharmacokinetic (PK) and tolerability of Oral IXAZOMIB when administered in combination with lenalidomide and dexamethasone in adult Asian patients with Relapsed and/or Refractory Multiple Myeloma

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
IXAZOMIB+Lenalidomide+Dexamethasone
ixazomib
Patients will receive Oral IXAZOMIB (4.0 mg) on Days 1, 8, and 15; lenalidomide (25 mg) on Days 1 through 21; and dexamethasone (40mg) on Days 1, 8, 15, and 22.

Primary Outcomes

Measure
Pharmacokinetic (PK) parameters including, but not limited to Cmax, Tmax and AUC 0-last
time frame: Cycle 1 - Day 1,2, 3, 5, 8, 15, 16, 17, 19, 22; Cycle 2- Day 1
Number of Adverse Events (AEs), Serious Adverse Events (SAEs), assessments of clinical laboratory values, and vital sign measurements
time frame: Recorded from the first dose of study drug through 30 days after the last dose of study drug

Secondary Outcomes

Measure
Number of patients with a response
time frame: Assessed every other cycle during treatment until disease progression, approximately 1 year
Duration of response (DOR)
time frame: From date of documentation of a confirmed response to date of progressive disease, approximately 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Male or female East Asian patients 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 - Patients 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 patients 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 patients 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 patients 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 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 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

Additional Information

Official title A Phase 1 Pharmacokinetic Study of Oral IXAZOMIB (MLN9708) Plus Lenalidomide and Dexamethasone in Asian Patients With Multiple Myeloma
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Takeda.