Effect of AT7519M Alone and AT7519M Plus Bortezomib in Patients With Previously Treated Multiple Myeloma

Completed · Phase 1/Phase 2

Conditions studied: Multiple Myeloma

In brief

The purpose of this study is to determine whether AT7519M alone or AT7519M plus bortezomib are effective treatments in patients with previously treated multiple myeloma.

Key facts

Study ID

NCT01183949

Run by

Astex Pharmaceuticals, Inc.

People needed

18

Starts

2010-11-01

Expected to finish

2015-03-01

Last updated by the study team

2024-08-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability to understand the risks of the study and provide signed informed consent
• Age 18 years or older
• Relapsed and or Refractory MM
• Disease progression following at least two systemic treatments for MM
• Patient must be refractory to the last bortezomib
• ECOG performance status 0, 1 or 2

You may not qualify if…

• Pregnant or lactating females. Patients of childbearing potential must use appropriate birth control throughout the study
• Inadequate liver function
• Renal impairment
• Neutrophil count <1.0 x 10\^9 /litre in the absence of growth factors
• Platelet count <50 x 10\^9 /litre in patients in whom <50% of bone marrow nucleated cells are plasma cells and <30 x 10\^9 /litre in patients in whom ≥50 % of bone marrow nucleated cells are plasma cells
• Hemoglobin <8g/dl in the absence of transfusion
• Treated corrected calcium >ULN
• Serum creatine phosphokinase >ULN
• All previous cytotoxic therapies for MM must have been completed at least four weeks prior to treatment with AT7519M (two weeks for all non-cytotoxic therapy)
• Patients may be receiving concomitant therapy with biphosphonates and low dose corticosteroids. Bisphosphonates doses should be stable for at least 30 days prior to study drug administration. Corticosteroids doses should be stable for at least 7 days prior to study treatment
• Prior peripheral stem cell transplant within 12 weeks
• Evidence of mucosal or internal bleeding and/or platelet transfusion refractory (unable to maintain a platelet count >50 x 10\^9 /litre)
• Ongoing infection requiring treatment
• Previous radiotherapy within 2 weeks of the start of the study
• Having previously received treatment with a cyclin-dependent kinase or GSK3beta inhibitor
• Incomplete recovery from previous radiotherapy other than residual cutaneous effects or stable < Grade 2 gastrointestinal toxicity
• Prior radiotherapy to the head and neck region for head and neck tumors
• Previous malignancy, except for non-melanomatous skin carcinomas, in situ carcinomas or malignancies with low risk of recurrence.
• Any severe or uncontrolled systemic conditions (e.g. systemic infection) or current unstable or uncompensated respiratory or cardiac conditions which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol
• Incomplete recovery from surgery other than stable < Grade 2 toxicity
• Peripheral neuropathy > Grade 2
• Abnormal left ventricular ejection fraction (< lower limit of normal for the institution for a patient of that age) on echocardiogram
• History of an ischemic cardiac event, including myocardial infarction within 3 months of study entry
• Congestive cardiac failure of ≥ grade 3 severity according to NYHA functional classification
• Unstable cardiac disease

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana Faber Cancer Institute — Boston, Massachusetts, United States
• Memorial Sloan-Kettering Cancer Centre — New York, New York, United States
• MCW and Froedtert Clinical Cancer Center, Division of Neoplastic Diseases & Related Disorders — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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