BridgeMD
New treatment option for Multiple Myeloma
Official title Self-administration of Subcutaneous Elranatamab in the Patients' Homes.
ClinicalTrials.gov ID: NCT06015542
What this study is testing
What is Elranatamab?
Elranatamab is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for multiple myeloma.
Also referred to as PF-06863135.
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 goal of this open label, phase two, prospective, non-randomized, sponsor-initiated explorative trial is to test self-administration of subcutaneous Elranatamab in the patients' homes in patients with relapsed multiple myeloma exposed to at least one proteasome inhibitor, one IMID and one anti CD-38 antibody. The main question(s)it aims to answer are: To evaluate the safety of self-administration of Elranatamab in the patients' own homes using registrations of occurrence of CRS, Immune effector cell-associated neurotoxicity syndrome (ICANS) and infections.
- Phase 2: a mid-size study of how well it works
- 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 and older
You may be able to join if
- ≥ 18 years of age at the time of signing the informed consent form.
- Relapsed MM according to the IMWG criteria.
- Measurable disease defined as: M-protein quantities ≥ 0.5 g/dL by serum protein electrophoresis (sPEP) or ≥ 200 mg/24-hour urine collection by urine...
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0, 1 or 2.
- Previously exposed to at least two of the following; one proteasome inhibitor, one IMID, or one anti CD-38 antibody.
You likely can't join if
- Any significant medical condition, laboratory abnormality or psychiatric illness that would prevent the subject from participating in the study.
- Prior history of ICANS.
- Prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years with the exception of the following...
- Basal cell carcinoma of the skin
- Squamous cell carcinoma of the skin
- Carcinoma in situ of the cervix
See the full eligibility criteria
- ≥ 18 years of age at the time of signing the informed consent form.
- Relapsed MM according to the IMWG criteria.
- Measurable disease defined as: M-protein quantities ≥ 0.5 g/dL by serum protein electrophoresis (sPEP) or ≥ 200 mg/24-hour urine collection by urine protein electrophoresis (uPEP) and/or Serum free light chain (FLC)...
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0, 1 or 2.
- Previously exposed to at least two of the following; one proteasome inhibitor, one IMID, or one anti CD-38 antibody.
- Documented disease progression during or after last anti-myeloma regimen.
- Possibility of being observed by a capable caregiver during self-administration.
- ANC ≥1.0 x 109/L (G-CSF allowed).
- Platelets ≥25 x 109/L.
- Female patients of childbearing potential must have a negative serum pregnancy test at screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing...
- Any significant medical condition, laboratory abnormality or psychiatric illness that would prevent the subject from participating in the study.
- Prior history of ICANS.
- Prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years with the exception of the following non-invasive malignancies:
- Basal cell carcinoma of the skin
- Squamous cell carcinoma of the skin
- Carcinoma in situ of the cervix
- Carcinoma in situ of the breast
- Incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes and metastasis] clinical staging system) or prostate cancer that is curative
- Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes) or clinically significant Amyloidosis.
- Female who is pregnant, breastfeeding or who intends to become pregnant during the participation in the study.
- Positivity for human immunodeficiency virus (HIV), chronic or active hepatitis B or active hepatitis A or C.
- Resident on an unbridged island.
- Not being able to register PRO-data electronically.
The study team makes the final eligibility decision.
Where it's taking place
- Odense, Denmark
- Vejle, Denmark
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Odense, Denmark; Vejle, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.