Tests HDP-101 for safety in people with relapsed multiple myeloma
Tests HDP-101 for safety and early effects in adults with multiple myeloma.
Plain-language title generated from the registry record
Registry title: Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma
Key facts
- Where
- Bucharest and Cluj-Napoca, RomaniaSee the 2 sites
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which of these best describes your myeloma treatment so far?
- Has a doctor told you that your myeloma can be measured in your blood or urine tests?
- Which describes how well you can look after yourself?
- Has a doctor told you that you have myeloma in the brain or in the fluid and membranes around the brain and spinal cord, now or in the past?
Source: NCT04879043, who can take part
Where in Romania
- Arensia Clinics S.R.L.Bucharest, RomaniaTaking people
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-NapocaCluj-Napoca, RomaniaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Heidelberg Pharma AG
- Trial code
- NCT04879043EU 2024-515273-10-00
- Record updated
- 17 September 2026
- Original description
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.Read full original descriptionShow less
A Phase 1/2a, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HDP-101 in Patients With Plasma Cell Disorders Including Multiple Myeloma
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.
Inclusion: Male or female aged ≥18 years; Life expectancy >12 weeks; Eastern Cooperative Oncology Group Performance Status (PS) of 0 to 2; A confirmed diagnosis of active MM according to the diagnostic criteria established by the International Myeloma Working Group (IMWG); Must have undergone SCT or is considered transplant ineligible; Must have undergone prior treatments with antimyeloma therapy which must have included an immunomodulatory drug, proteasome inhibitor, and anti-CD38 treatment, alone or in combination. In addition, the patient should either refractory or intolerant to any established standard of care therapy providing a meaningful clinical benefit for the patient assessed by the Investigator; Measurable disease as per IMWG criteria; Adequate organ system function as defined in protocol.
Exclusion: For patient entering the Phase 2a part only: Prior treatment with any approved or experimental BCMA-targeting modalities are not allowed; Autologous or allogenic SCT within 12 weeks before the first infusion or is planning for autologous SCT; Symptomatic graft versus host disease post allogenic hemopoietic cell transplant within 12 months prior to the first study treatment infusion; Radiotherapy within 21 days prior to the first study treatment infusion; History of congestive heart failure; History of any other malignancy known to be active; Known human immunodeficiency virus infection; Patients with active infection requiring systemic anti-infective; Patients with positive test results for hepatitis B surface antigen or Hepatitis B core antigen; Patients with positive test results for hepatitis C virus (HCV) infection; Current active liver or biliary disease; Known central nervous system involvement; Plasma cell leukemia.