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Summary

for people ages 18 years and up (full criteria)
at Berkeley, California and other locations
study started
estimated completion:

Description

Summary

This will be a phase 1/2, multicenter, open-label study using the oral formulation of IXAZOMIB administered twice weekly in combination with lenalidomide and low-dose dexamethasone. Both phases of the study will include patients who have newly diagnosed multiple myeloma and have not previously received systemic treatment. Both the phase 1 and the phase 2 portions of the study will include induction therapy consisting of 1 year of therapy followed by maintenance therapy that will continue until progressive disease or unacceptable toxicity. Maintenance therapy will be IXAZOMIB alone on Days 1,4,8, & 11 of a 21-day cycle.

Official Title

An Open-Label, Dose-Escalation, Phase 1/2 Study of the Oral Formulation of IXAZOMIB (MLN9708), Administered Twice-weekly in Combination With Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Requiring Systemic Treatment

Keywords

Multiple Myeloma Neoplasms, Plasma Cell Dexamethasone acetate Dexamethasone Lenalidomide Ixazomib Thalidomide BB 1101 Glycine

Eligibility

You can join if…

Open to people ages 18 years and up

  • Male or female patients 18 years or older
  • Symptomatic multiple myeloma or asymptomatic myeloma with myeloma-related organ damage diagnosed according to standard criteria
  • Measurable disease as specified in study protocol
  • Hematologic, liver, and renal function as specified in the study protocol.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • 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

You CAN'T join if...

  • Peripheral neuropathy that is greater or equal to Grade 2
  • Female patients who are lactating or pregnant
  • Major surgery or radiotherapy within 14 days before the first dose of study drug
  • Uncontrolled infection requiring systematic antibiotics within 14 days before the first dose of study drug
  • Diarrhea (> Grade 1)
  • Prior systemic therapy for multiple myeloma, including investigational drugs (prior treatment with corticosteroids or localized radiation therapy dose not disqualify the patient)
  • Systemic treatment with strong inhibitors of CYP1A2, strong inhibitors of CYP3A, or strong CYP3A inducers, or use of Ginkgo biloba or St. John's wort within 14 days before the first dose of study treatment
  • Central nervous system involvement
  • Diagnosis of smoldering multiple myeloma, Waldenstrom's macroglobulinemia, POEMS syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome
  • Evidence of current uncontrolled cardiovascular conditions
  • Prior or concurrent deep vein thrombosis or pulmonary embolism
  • Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection
  • 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, or tolerance of IXAZOMIB
  • Diagnosed or treated for another malignancy within 2 years before the first dose 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

Locations

  • UCSF Medical Center
    Berkeley, California, 94704, United States
  • Stanford University
    Stanford, California, 94305, United States
  • City of Hope National Medical Center
    Duarte, California, 91010, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Millennium Pharmaceuticals, Inc.
ID
NCT01383928
Phase
Phase 1/2
Study Type
Interventional
Last Updated
October 6, 2017