The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis
| Status: | Completed |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/6/2019 |
| Start Date: | March 2016 |
| End Date: | March 2018 |
A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis Who Have Persistent Cardiac Dysfunction
This is a global, multicenter, Phase 2b, randomized, double-blind, placebo-controlled,
two-arm, parallel-group efficacy and safety study of NEOD001 as a single agent administered
intravenously in adults with AL amyloidosis who had a hematologic response to previous
treatment for their amyloidosis (e.g., chemotherapy, autologous stem cell transplant [ASCT])
and have persistent cardiac dysfunction.
two-arm, parallel-group efficacy and safety study of NEOD001 as a single agent administered
intravenously in adults with AL amyloidosis who had a hematologic response to previous
treatment for their amyloidosis (e.g., chemotherapy, autologous stem cell transplant [ASCT])
and have persistent cardiac dysfunction.
Inclusion Criteria:
1. Age ≥18 years
2. Confirmed diagnosis of systemic AL amyloidosis
3. ≥1 prior systemic plasma cell dyscrasia therapy with at least a partial hematologic
response
4. Cardiac involvement
5. NT-proBNP ≥650
Exclusion Criteria:
1. Non-AL amyloidosis
2. Meets the International Myeloma Working Group (IMWG) definition of Multiple Myeloma
3. NT-proBNP >5000
4. Received Plasma cell directed chemotherapy within 6 months
5. Received autologous stem cell transplant (ASCT) within 12 months
We found this trial at
20
sites
72 East Concord Street
Boston, Massachusetts 02118
Boston, Massachusetts 02118
(617) 638-5300
Principal Investigator: Vaishali Sanchorawala, MD
Phone: 617-638-6519
Boston University School of Medicine A leader in medical education and research, Boston University School...
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800 Washington St
Boston, Massachusetts 02111
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Raymond Comenzo, MD
Phone: 339-222-9307
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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9500 Euclid Avenue
Cleveland, Ohio 44106
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Jason Valent, MD
Phone: 216-444-4432
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Stacey Goodman, MD
Phone: 615-875-6120
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
Principal Investigator: Brendan Weiss, MD
Phone: 215-662-3173
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Principal Investigator: Stephen Heitner, MD
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Chicago, Illinois 60637
Principal Investigator: Cara Rosenbaum, MD
Phone: 773-702-1835
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1721 East 19th Ave., Suite #200 & #300
Denver, Colorado 80218
Denver, Colorado 80218
720-754-4800
Principal Investigator: Tara Gregory, MD
Phone: 720-754-4890
Colorado Blood Cancer Institute When patients come to the Colorado Blood Cancer Institute, the entire...
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Detroit, Michigan 48201
Principal Investigator: Jeffrey Zonder, MD
Phone: 313-576-9381
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Duarte, California 91010
Principal Investigator: Michael Rosenzweig, MD
Phone: 626-256-4673
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2301 Erwin Rd
Durham, North Carolina 27710
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Cristina Gasparetto, MD
Phone: 919-688-5579
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
Principal Investigator: Hans Lee, MD
Phone: 713-745-1889
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Indianapolis, Indiana 46202
Principal Investigator: Rafat Abonour, MD
Phone: 317-274-0843
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Milwaukee, Wisconsin 53226
Principal Investigator: Anita D'Souza, MD
Phone: 414-805-0700
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1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Principal Investigator: Heather Landau, MD
Phone: 664-449-1339
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Rochester, Minnesota 55905
Principal Investigator: Morie Gertz, MD
Phone: 507-284-3725
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Seattle, Washington 98109
Principal Investigator: Edward Libby, MD
Phone: 206-288-7140
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Stanford, California 94305
Principal Investigator: Michaela Liedtke, MD
Phone: 650-723-0646
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Sydney, New South Wales 2145
Principal Investigator: Fiona Kwow, MD
Phone: 02 9845 6274
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