Elimination of Minimal Residual Disease After Transplant (NCT05690984) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Elimination of Minimal Residual Disease After Transplant
United States30 participantsStarted 2023-06-26
Plain-language summary
This is a single-center, single-arm, phase II study that will enroll multiple myeloma (MM) patients with persistent bone marrow minimal residual disease (MRD) post autologous stem cell transplant (ASCT) irrespective of the International Myeloma Working Group (IMWG) response.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status criteria of 0-2.
✓. Must have archival bone marrow sample at time of diagnosis that can be used for clonality identification for NGS if not already performed.
✓. Presence of residual bone marrow minimal residual disease (MRD) positivity by clonoSEQ® next-generation sequencing (NGS) 90-120 days post autologous stem cell transplantation.
✓. Histologically confirmed diagnosis of symptomatic multiple myeloma (patients with multiple myeloma with secondary amyloidosis are eligible, but no amyloid treatment will be allowed while on study).
✓. Received autologous stem cell transplant as upfront therapy for myeloma (defined as ASCT within one year of diagnosis of symptomatic MM).
✓. Adequate organ function as defined below:
✓. Pregnancy It is not known what effects this treatment has on human pregnancy or development of the embryo or fetus. Therefore, female subjects participating in this study should avoid becoming pregnant, and male subjects should avoid impregnating a female partner. Non-sterilized female subjects of reproductive age and male subjects should use effective methods of contraception through defined periods during and after study treatment as specified below.
Exclusion criteria
✕. Evidence of MM disease progression any time prior to enrollment.
✕. Administration or planned administration of any other concomitant chemotherapy, immunotherapy, or any ancillary therapy that would be considered a treatment of multiple myeloma from Day +30 post-transplant through discontinuation from study. Local radiation therapy is allowed. Subjects may be on corticosteroids if they are being given for disorders other than multiple myeloma (e.g., adrenal insufficiency, rheumatoid arthritis, etc.)
✕. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
✕. Prior organ transplant requiring immunosuppressive therapy.
✕. Known to be human immunodeficiency virus (HIV) positive.
✕. Known to have hepatitis A, B, or C active infection. If hepatitis positive, patient may still be per the notes below.
✕. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
✕. Concurrent hematologic or non-hematologic malignancy requiring treatment (other than multiple myeloma and secondary amyloidosis).