Multiple Myeloma study: Treosulfan vs Melphalan
Official title Clinical Trial Investigating the Chemotherapeutic Compound Treosulfan (Trecondi® Ideogen) in Myeloma Patients
ClinicalTrials.gov ID: NCT05636787
What this study is testing
What is Treosulfan?
Treosulfan is an investigational chemotherapy medicine being studied to see if adding it to standard treatment helps treat multiple myeloma. It is designed to damage the DNA of rapidly dividing cells, such as cancer cells, to stop them from growing.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how well Treosulfan works and how safe it is for patients with multiple myeloma.
- Who it's for
- Adults who have been diagnosed with multiple myeloma.
- What's involved
- Participants will receive Treosulfan as part of the study and may have blood tests and other routine checks to monitor their health.
- Time commitment
- The study lasts for the period of treatment and follow‑up visits as scheduled by the investigators.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 36 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Eligible are myeloma patients after standard first-line induction treatment. Additional induction regimens in refractory myeloma patients are allowed.
- Patients must be considered fit for subsequent consolidation with high-dose chemotherapy with autologous stem cell transplantation.
- Patients must be aged 18-75 years.
- Patients must have an ECOG \<3.
- Patients must have a creatinine clearance ≥35 ml/min.
You likely can't join if
- Patients with an uncontrolled acute infection.
- Patients with a transplantation comorbidity index (HCTCI) \> 6 points.
- Patients with concurrent active malignant disease with the exception of basalioma/spinalioma of the skin or early-stage cervix carcinoma, or...
- Patients with major coagulopathy or bleeding disorder.
- Patients with other medical conditions that could potentially interfere with the completion of treatment according to this protocol or that would...
- Lack of patient cooperation to allow study treatment as outlined in this protocol.
See the full eligibility criteria
- Eligible are myeloma patients after standard first-line induction treatment. Additional induction regimens in refractory myeloma patients are allowed.
- Patients must be considered fit for subsequent consolidation with high-dose chemotherapy with autologous stem cell transplantation.
- Patients must be aged 18-75 years.
- Patients must have an ECOG \<3.
- Patients must have a creatinine clearance ≥35 ml/min.
- Patients must have an LVEF ≥40% within three months prior to start of study HDCT.
- Patients must have given voluntary written informed consent.
- Patients with an uncontrolled acute infection.
- Patients with a transplantation comorbidity index (HCTCI) \> 6 points.
- Patients with concurrent active malignant disease with the exception of basalioma/spinalioma of the skin or early-stage cervix carcinoma, or early-stage prostate cancer.
- Patients with major coagulopathy or bleeding disorder.
- Patients with other medical conditions that could potentially interfere with the completion of treatment according to this protocol or that would impair tolerance to therapy or prolong hematological recovery.
- Lack of patient cooperation to allow study treatment as outlined in this protocol.
- Known pregnancy or lactating female patients. The pregnancy test could be omitted from the screening visit and postponed to the study treatment if indicated (a pregnancy test in female patients of child-bearing...
- Use of any anti-cancer investigational agents within 14 days prior to the expected start of trial treatment.
- Contraindications and hypersensitivity to any of the active chemotherapy compounds.
The study team makes the final eligibility decision.
Where it is enrolling
- Bern, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 36 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bern, Switzerland. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.