Tests HDP-101 for safety in people with relapsed multiple myeloma
Tests HDP-101 for safety and early effects in adults with multiple myeloma.
Key facts
- Who runs it
- Heidelberg Pharma AG
- Where
- Bucharest and Cluj-Napoca, RomaniaSee the 2 sitesAlso in 5 other countries, 23 sites
- Registry title
- Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 78 people, planned
- Started
- 7 Feb 2022
- Expected to end
- Sept 2028
- Type of study
- Interventional
- Treatments tested
- HDP-101
- Record updated
- 17 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with active multiple myeloma that has come back or has not responded to earlier treatment. They must already have had several standard myeloma treatments.
- Age
- 18 years or older
- Sex
- Women and men
- Disease stage
- Active multiple myeloma confirmed by IMWG criteria, with measurable disease. The cancer must be refractory to or not tolerate standard therapy. Life expectancy over 12 weeks and ECOG performance status 0 to 2.
- Earlier treatment
- Must have had a stem cell transplant or be unable to have one. Must have had an immunomodulatory drug, a proteasome inhibitor and anti-CD38 treatment. For phase 2a, no earlier BCMA-targeting treatment.
Main reasons for not taking part
- Known central nervous system involvement
- Plasma cell leukemia
- History of congestive heart failure
- Known HIV infection
- Active hepatitis B or hepatitis C infection, or active liver or biliary disease
The registry criteria, word for word
Show all 21 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
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?
Where in Romania
Also in 5 other countries, 23 sites
- Arensia Clinics S.R.L.Bucharest, RomaniaTaking people
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-NapocaCluj-Napoca, RomaniaTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- HDP-101Treatment being tested
Participants will receive HDP-101 intravenously in a 21 day cycle until disease progression, intolerable toxicity, Investigator's discretion or patient withdrawal. During the phase 1 tolerability of different dose levels will be evaluated. During the phase 2a dose expansion part the recommended phase 2 dose (RP2D) of HDP-101 will be administered.
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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
- Plain-language title
- Tests HDP-101 for safety in people with relapsed multiple myelomaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT04879043, who can take part
- Record updated
- 17 September 2026