Actively Recruiting
Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma
Led by Heidelberg Pharma AG · Updated on 2024-07-24
78
Participants Needed
16
Research Sites
220 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will assess the safety, tolerability, pharmacokinetics (PK) and the therapeutic potential of HDP-101 in patients with plasma cell disorders including multiple myeloma.
CONDITIONS
Official Title
Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 6518 years
- Life expectancy greater than 12 weeks
- Eastern Cooperative Oncology Group Performance Status of 0 to 2
- Confirmed diagnosis of active multiple myeloma by International Myeloma Working Group criteria
- Have undergone stem cell transplant or are transplant ineligible
- Prior treatment with immunomodulatory drug, proteasome inhibitor, and anti-CD38 therapy
- Disease measurable by International Myeloma Working Group criteria
- Adequate organ function as defined in the protocol
You will not qualify if you...
- For Phase 2a only: prior treatment with any approved or experimental BCMA-targeting therapies
- Known central nervous system involvement
- Plasma cell leukemia
- History of congestive heart failure
- Stem cell transplant within 12 weeks before first infusion or planned transplant
- Symptomatic graft versus host disease within 12 months before first infusion
- Radiotherapy within 21 days before first infusion
- Active other malignancy
- Known HIV infection
- Active infection requiring systemic anti-infective treatment
- Positive for hepatitis B surface or core antigen
- Positive for hepatitis C virus infection
- Current active liver or biliary disease
AI-Screening
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Trial Site Locations
Total: 16 locations
1
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
Mount Sinai, The Tisch Cancer Instutute
New York, New York, United States, 10029
Actively Recruiting
3
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
4
Charité - Campus Benjamin Franklin Med. Klinik m.S. Hämatologie, Onkologie
Berlin, Germany, 12203
Not Yet Recruiting
5
Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin III
Chemnitz, Germany, 09116
Actively Recruiting
6
Universitätsklinikum Köln
Cologne, Germany, 50937
Actively Recruiting
7
Asklepios Klinik Altona, Haematologie und internistische Onkologie
Hamburg, Germany, 22763
Actively Recruiting
8
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
9
Universitätsklinikum Schleswig-Holstein
Kiel, Germany, 24105
Actively Recruiting
10
UKSH Campus Lübeck Klinik für Hämatologie und Onkologie
Lübeck, Germany, 23538
Actively Recruiting
11
Universitätsklinikum Mainz
Mainz, Germany, 55131
Withdrawn
12
Semmelweis University, Belgyogyaszati es Onkologiai Klinika
Budapest, Hungary, 1083
Actively Recruiting
13
National Institute of Oncology, Department of Oncological Internal Medicine
Budapest, Hungary, 1122
Actively Recruiting
14
Pratia Onkologia Katowice
Katowice, Poland, 40-519
Actively Recruiting
15
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz, Poland, 93-513
Not Yet Recruiting
16
Szpital Wojewodzki w Opolu
Opole, Poland, 45-061
Not Yet Recruiting
Research Team
A
András Strassz, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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