The MM Study
The purpose of this study is to establish the safety and preliminary efficacy of infusing the investigational medication in newly diagnosed MM patients who are in first or second remission before undergoing autologous stem cell transplant (ASCT).
Length of Study
# Study Visits
Post-study Follow Up
Adults; All genders
Drug & Formulation
Possibility of Placebo
Multiple myeloma is a type of blood cancer of the plasma cell that develops in the bone marrow, the soft tissue inside bones. Healthy plasma cells produce antibodies, which are critical for the immune system’s ability to recognize disease-causing entities, such as bacteria, viruses and tumor cells. In multiple myeloma, however, genetic abnormalities in a single plasma cell cause it to divide uncontrollably. Many patients are diagnosed due to symptoms such as bone pain or fractures, kidney failure (thirst, dehydration, confusion), nerve pain, fever and weakness.
- Have measurable disease according to standard diagnostic criteria at the time of initial MM diagnosis
- Meet criteria for symptomatic MM at the time of induction chemotherapy
- Be transplant eligible based on clinician judgement
- Be willing to undergo ASCT in first or second remission
- Achieve partial response or better with induction chemotherapy prior to ASCT according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for MM
- Be MRD+ upon restaging prior to stem cell collection and ASCT
- Have an Eastern Cooperative Oncology Group (EGOG) performance status score of less than 2
- Have a life expectancy greater than six months
- Have no evidence of active or decompensated heart failure, no recent history (past 6 months) of acute myocardial infarction, no evidence of severe valvular disease and must have a LVEF over 50% at the time of transplant evaluation
- Have adequate kidney function, bone marrow function and hepatic function
- Have no evidence of moderate/severe restrictive or obstructive lung disease at the time of transplant evaluation
- Be willing to undergo CD34+ cell collection for stem cell transplant and leukapherisis
- If 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
- Have prior
- autologous or allogeneic hematopoietic stem cell transplant
- cellular therapies, including NK cell therapy
- treatment with monoclonal antibodies
treatment with melphalan
- treatment with immunosuppressive or immunomodulatory agents within 30 days of enrollment
- Have disease progression at the time of enrollment
- Have non secretory MM (defined as normal serum and urine immunofixation and normal serum free light chain assay)
- Have history of plasma cell leukemia at any time prior to enrollment
- Have seropositivity for the human immunodeficiency virus (HIV)
- Have uncontrolled hepatitis C virus or hepatitis B virus infection
- Have received other investigational or anti-myeloma drugs within 30 days of enrollment
- Have active, clinically significant autoimmune diseases and cancer other than MM
- Have neurological conditions that make difficult the assessment of neurologic toxicity of the combination product
Frequently Asked Questions
About 25 people will participate in this study.
The study is being conducted on behalf of Biohaven by Dana-Farber Cancer Institute.
Contact the Dana-Farber Cancer Institute at 877-442-3324 or visit https://www.dana-farber.org/multiple-myeloma-program/ .