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New treatment option for Multiple Myeloma
Official title Free From Maintenance Drug Therapy in Multiple Myeloma (The FREEDMM Trial) for Minimal Residual Disease (MRD
ClinicalTrials.gov ID: NCT05192122
What this study is testing
- What it's testing
- A pilot study to assess the risk of progression after stopping post-autologous stem cell transplant (ASCT) maintenance therapy in Minimal Residual Disease (MRD)-negative MM patients.
- Phase 1: an early, usually small safety study
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
- ECOG Performance Status equal to or less than 2 within 30 days prior to registration
- Revised International Staging System (R-ISS) I,2 or 3
- Patients with multiple myeloma as defined by IMWG
- Received at least 2 years of post ASCT maintenance (patients may have received any number of prior lines of therapy).
- Maintenance therapy is defined as any anti-myeloma therapy initiated after ASCT to prevent disease recurrence and prolong time in remission (i.e...
You likely can't join if
- Patients with plasma cell leukemia, AL amyloidosis or Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin (POEMS) syndrome
- Prior organ transplant or condition requiring immunosuppressive therapy
- Prior allogeneic hematopoietic cell transplant
- Treatment with any investigational drug within 30 days prior to enrollment
- Unable to sign an informed consent or their legally authorized represnetative
See the full eligibility criteria
- ECOG Performance Status equal to or less than 2 within 30 days prior to registration
- Revised International Staging System (R-ISS) I,2 or 3
- Patients with multiple myeloma as defined by IMWG
- Received at least 2 years of post ASCT maintenance (patients may have received any number of prior lines of therapy).
- Maintenance therapy is defined as any anti-myeloma therapy initiated after ASCT to prevent disease recurrence and prolong time in remission (i.e., lenalidomide, bortezomib, RVD, etc.)
- Disease response is VGPR or CR at the time of enrollment as defined by IMWG criteria.
- Patients or their legally authorized representative must be able to understand and be willing to sign a voluntary informed consent form and agree to compliance with the protocol schedule; with the knowledge that they...
- Patients with plasma cell leukemia, AL amyloidosis or Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin (POEMS) syndrome
- Prior organ transplant or condition requiring immunosuppressive therapy
- Prior allogeneic hematopoietic cell transplant
- Treatment with any investigational drug within 30 days prior to enrollment
- Unable to sign an informed consent or their legally authorized represnetative
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
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 - 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 Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
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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.