Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Biohaven Pharmaceuticals, Inc.
With
Dana-Farber Cancer Institute
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Had measurable disease according to Standard Diagnostic Criteria at the time of initial Multiple Myeloma diagnosis
Meets criteria for symptomatic multiple myeloma at the time of induction chemotherapy
Is transplant eligible based on clinician judgement
Willing to undergo ASCT in first or second remission
Achieve partial response or better with induction chemotherapy prior to ASCT according to the IMWG Uniform Response Criteria for Multiple Myeloma
Be MRD+ upon restaging prior to stem cell collection and ASCT
Eastern Cooperative Oncology Group (EGOG) performance status score of less than 2
Life expectancy greater than six months
Have a creatinine clearance \> 45 mL/min/m2 at the time of transplant evaluation
If frozen stem cells from earlier mobilized leukapheresis are unavailable at the time of mobilized leukapheresis, patients must meet parameters/criteria according to institutional SOP for autologous stem cell apheresis
Be willing and clinically stable to undergo stem-cell mobilized and collect enough CD34+ cells sufficient for 2 ASCT per institutional guidelines or investigator discretion or have sufficient frozen cells from a SoC collection prior to signing study consent
Be willing and clinically stable to undergo a non-mobilized MNC-Apheresis while admitted to the hospital to generate CIML NK cells
Be willing to undergo maintenance after ASCT per NCCN guidelines based on disease risk
If a woman of child-bearing potential, be willing to follow birth control and pregnancy testing practice as recommended
Be willing to undergo bone marrow aspirate and biopsy as per treatment plan
Patients must meet adequate organ function/reserve based on institutional SOP for autologous stem cell transplant eligibility
Non-secretory MM can participate if they have measurable disease in the bone marrow and are amenable to be followed by MRD testing
You may not be if
Prior autologous or allogeneic hematopoietic stem cell transplant
Prior cellular therapies, including NK cell therapy
Prior treatment with monoclonal antibodies, within 28 days of MCN apheresis
Prior treatment with high dose melphalan
Prior treatment with immunosuppressive or immunomodulatory agents with exception of 5 mg or less of prednisone daily, within 14 days of MCN-Apheresis
Disease progression at the time of study treatment
History of Plasma Cell Leukemia at any time prior to enrollment
Patients seropositive for the human immunodeficiency virus (HIV)
Uncontrolled, Hepatitis C Virus or Hepatitis B Virus infection
Patient receiving other investigational therapy
Patients with active, clinically significant autoimmune diseases
Patients with active, clinically significant cancer other than multiple myeloma
Patients with severe, uncontrolled psychiatric or neurological conditions that make difficult the assessment of neurologic toxicity of the study treatment
Patients who have received anti-MM therapy (with the exclusion of monoclonal antibodies) within 14 days of study treatment
More than two prior lines of anti-myeloma therapy, with induction therapy followed by maintenance being considered as one line and CyBorD to RVD transition in the absence of progressive disease being considered as one line
Clareo Health | Autologous Memory-like NK Cell Therapy With BHV-1100 and Low Dose IL-2 in Multiple Myeloma Patients
