NL-OMON50586
Completed
Phase 3
A Phase 3 Randomized, Controlled, Open-label, Multicenter, Safety and Efficacy Study of Dexamethasone Plus MLN9708 or Physician's Choice of Treatment Administered to Patients With Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis - MLN9708 (C16011; 0114/0065)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- primary amyloidosis
- Sponsor
- Millenium Pharmaceuticals
- Enrollment
- 7
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial ended prematurely
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female patients 18 years or older., 2\. Biopsy\-proven diagnosis of AL
- •amyloidosis according to the following standard criteria:, a. Histochemical
- •diagnosis of amyloidosis, as based on tissue specimens with Congo red staining
- •with exhibition of an apple\-green birefringence, b. If clinical and laboratory
- •parameters insufficient to establish AL amyloidosis or in cases of doubt,
- •amyloid typing may be necessary (see Section 15\.1\), 3\. Measurable disease as
- •defined by serum differential free light chain concentration
- •(dFLC, difference between amyloid forming \[involved] and nonamyloid forming
- •\[uninvolved] free light chain \[FLC]) \>\= 50 mg/L)., 4\. Objective, measurable
- •major (cardiac or renal ) organ amyloid involvement as defined as follows
Exclusion Criteria
- •Prospective patients will be excluded from this study if they meet ANY of the
- •following criteria:, 1\. Amyloidosis due to mutations of the transthyretin gene
- •or presence of other, non\-AL amyloidosis., 2\. Female patients who are
- •lactating, breastfeeding, or pregnant., 3\. Medically documented cardiac
- •syncope, uncompensated NYHA Class 3 or 4 congestive heart failure (Section
- •15\.6\), myocardial infarction within the previous 6 months, unstable angina
- •pectoris, clinically significant repetitive ventricular arrhythmias despite
- •antiarrhythmic treatment, or severe orthostatic hypotension or clinically
- •important autonomic disease., 4\. Clinically overt multiple myeloma, according
- •to the IMGW criteria with at least 1 of the following:
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 3
A Phase 3, Randomized, Open-Label, Controlled, Multicenter Study of Zandelisib (ME-401) in Combination with Rituximab Versus Standard Immunochemotherapy in Patients with Relapsed Indolent Non-Hodgkin*s Lymphoma (iNHL) - The COASTAL Studycancer from white blood cellsLymph node cancer. Recurringslow growing10025322NL-OMON51210MEI Pharma Inc.1
Completed
Phase 3
A Randomized, Open-Label, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Avelumab (MSB0010718C) in Combination with and/or Following Chemotherapy in Patients with Previously Untreated Epithelial Ovarian Cancerovarian cancer10033283NL-OMON45949Pfizer30
Completed
Phase 3
A Phase 3, Randomized, Open-label Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined with Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence (PIVOT-12)MelanomaSkin cancer1004090010035023NL-OMON55317ektar Therapeutics12
Completed
Phase 3
A randomized, multicenter, double-blind phase 3 study of amcenestrant (SAR439859) plus palbociclib versus letrozole plus palbociclib for the treatment of patients with ER (+), HER2 (-) breast cancer who have not received prior systemic anti-cancer treatment for advanced diseaseAdvanced Breast cancer. Metastatic Breastcancer10006291NL-OMON55315Genzyme Europe BV17
Completed
Phase 3
A phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of lenalidomide (Revlimid®) as maintenance therapy for high-risk patients with chronic lymphocytic leukemia following first-line therapyNL-OMON44081HOVO5