Trial Condition(s):
Multiple myeloma
Phase 1b/2 study testing radium-223 dichloride/bortezomib/dexamethasone combination in relapsed multiple myeloma
Bayer Identifier:
17451
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
This study will be conducted in 2 parts. The phase 1b part will be an international, phase 1b, open-label, dose-escalation assessment of radium-223 dichloride administered with bortezomib and dexamethasone in subjects with relapsed multiple myeloma. The primary endpoint of the phase 1b part is to determine the optimal dose of radium-223 dichloride in combination with bortezomib/dexamethasone for the Phase 2 portion of the study.
The phase 2 part will be an international, phase 2, double-blind, randomized, placebo-controlled assessment of radium-223 dichloride versus placebo administered with bortezomib and dexamethasone, in subjects with relapsed multiple myeloma. Randomization (1:1) in the phase 2 part will be stratified by:
• Prior bortezomib treatment (yes, no)
• Prior treatment (1 prior line of treatment, >1 prior line of treatment)
Approximately 30 subjects (10 subjects per cohort) will be enrolled in the phase 1b part of the study and approximately 196 subjects will be enrolled in the phase 2 part of the study.
Inclusion Criteria
- Cytologically or histologically confirmed diagnosis of multiple myeloma - Subjects must have received at least 1 and not more than 3 previous lines of treatment and have had a response to treatment (i.e., achieved a minimal response [MR] or better) according to the International Myeloma Working Group (IMWG) uniform response criteria - Subjects must have had progressive disease according to the IMWG uniform response criteria following the last multiple myeloma treatment - Subjects must have measurable disease defined as at least 1 of the following (according to central laboratory results): -- Serum M-protein ≥1 g/dL -- Urine M-protein ≥200 mg/24 hours -- Serum free light chain (FLC) ≥10 mg/dL with abnormal ratio - ≥1 bone lesion identifiable by radiograph, computed tomography, magnetic resonance imaging, or bone scintigraphy - Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2 - Subjects must be nonrefractory to bortezomib and had no progression during or within 60 days after completion of bortezomib - Absolute neutrophil count (ANC) ≥1.5 × 10e9/L, hemoglobin (Hb) ≥9.0 g/dL, and platelet count ≥75.0 × 10e9/L independent of transfusion of red blood cells (RBC) or platelet concentrates and independent of granulocyte colony stimulating factor (G-CSF) or granulocyte macrophage colony stimulating factor (GM-CSF)
Exclusion Criteria
- Systemic glucocorticoid therapy (prednisone >10 mg/day orally or equivalent) within the last 4 weeks prior to first dose, unless tapered and on a stable dose ≤10 mg/day for at least 1 week - Subjects with known POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or light chain (AL) amyloidosis - Plasma cell leukemia - Systemic anti-cancer therapy within 4 weeks prior to first dose - Radiation therapy in the previous 4 weeks prior to first dose except if given for pain management and involves less than 10% of the bone marrow - Prior treatment with radium-223 dichloride or any experimental radiopharmaceutical - Congestive heart failure (New York Heart Association [NYHA] class III to IV), symptomatic cardiac ischemia, cardiomyopathy, clinically relevant ventricular arrhythmia, pericardial disease, unstable angina or myocardial infarct in the previous 6 months prior to first dose, left ventricular ejection fraction <40% - Neuropathy ≥ Grade 2 or Grade 1 with pain
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Encinitas, United States, 92024 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New York, United States, 10032-3729 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Torino, Italy, 10126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Novara, Italy, 28100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Watertown, United States, 57201 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jerusalem, Israel, 9112001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Afula, Israel, 1834111 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Haifa, Israel, 31048 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ramat Gan, Israel, 5262000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zerifin, Israel, 6093000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Athens, Greece, 11528 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rio / Patra, Greece, 26500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20089 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUGGE, Belgium, 8000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site YVOIR, Belgium, 5530 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LIEGE, Belgium, 4000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bologna, Italy, 40138 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Firenze, Italy, 50141 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Quebec, Canada, G1R 2J6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site München, Germany, 81377 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tübingen, Germany, 72076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 12203 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mainz, Germany, 55131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Winston-Salem, United States, 27157 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Valencia, Spain, 46017 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Palma de Mallorca, Spain, 07010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28046 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Sebastián, Spain, 20014 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sevilla, Spain, 41013 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seattle, United States, 98104 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 03080 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 137-701 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Scottsdale, United States, 85259-5404 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pisa, Italy, 56126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cagliari, Italy, 09121 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Durham, United States, 27710 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taipei, Taiwan, China, 10016 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taipei, Taiwan, China, 11217 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taichung, Taiwan, China, 40447 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taipei, Taiwan, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Daegu, South Korea, 700-701 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Goyang-si, South Korea, 410-769 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 138-736 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Little Rock, United States, 72205 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rockville, United States, 20850-6535 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Metairie, United States, 70006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jeollanam-do, South Korea, 519-763 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 135-710 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Badalona, Spain, 08916 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Reggio Emilia, Italy, 42123 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BOX HILL, Australia, 3128 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Adelaide, Australia, 5000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A phase 1b/2 trial to evaluate the safety and efficacy of radium-223 dichloride (BAY88-8223) in combination with bortezomib and dexamethasone in early relapsed multiple myeloma
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
5
Primary Outcome
- Joint positive adjudication of safety summary in Phase 1b by steering committee, investigator and sponsor (Yes/No)Timeframe: At 13 months
- Progression-free survival (PFS) in Phase 2, defined as the time (in days) from date of randomization to disease progressionTimeframe: Up to 25 months
Secondary Outcome
- Objective response rate (ORR) in Phase 1b, in the proportion of subjects in the analysis population who have complete response (CR), stringent complete response (sCR), very good partial response (VGPR), partial response (PR), or stable disease (SD)Timeframe: Approximately 12 months
- Duration of response in Phase 1b, defined as the time (in days) from the date of first response to treatment (CR, sCR, VGPR, PR) to the date of disease progression or deathTimeframe: Approximately 12 months
- Number of participants with adverse events in phase 2Timeframe: Up to 25 months
- Overall survival (OS) in Phase 2, defined as the time (in days) from date of randomization until death from any causeTimeframe: Up to 25 months
- Time to Symptomatic Skeletal Event (SSE) in Phase 2, defined as the time (days) from the date of randomization to the date of the first on-study SSETimeframe: Up to 25 months
- Symptomatic skeletal event free survival in Phase 2, defined as the time from randomization to the occurrence of 1 of the following: First on-study SSE or Death from any cause if death occurs before a documented SSETimeframe: Up to 25 months
- Time to pain progression in Phase 2Timeframe: Up to 25 months
- Duration of response in Phase 2Timeframe: Up to 25 months
- Objective Response Rate (ORR) in Phase 2Timeframe: Up to 25 months
Additional Information
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