A Study to Evaluate Myeloma-Developing Regimens Using Genomics (MyDRUG)

Overview

About this study

The purpose of this study is to treat patients with drugs targeted to affect specific genes that are mutated as part of the disease. Mutations in genes can lead to uncontrolled cell growth and cancer. Patients with a greater than 30% mutation to any of the following genes; CDKN2C, FGFR3, KRAS, NRAS, BRAF V600E, IDH2 or T(11;14) can be enrolled to one of the treatment arms. These arms have treatments specifically directed to the mutated genes. Patients that do not have a greater than 30% mutation to the genes listed can be enrolled to a non-actionable treatment arm. The genetic sequencing of the patient's tumor is required via enrollment to the MMRF002 study: Clinical-grade Molecular Profiling of Patients with Multiple Myeloma and Related Plasma Cell Malignancies. (NCT02884102).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

  • Have enrolled in the MMRF002 Molecular Profiling Protocol (NCT02884102) “companion’ protocol and have a report that is less than 120 days.
  • ≥ 18 years of age.
  • Willing to consent to the assigned Sub-Protocol.
  • Patient meets all entry criteria for the assigned Sub-Protocol.
  • High risk patients with relapsed refractory multiple myeloma (RRMM), who have:
    • received at least one prior but no more than 3 prior therapies;
    • exposed to both a PI and an IMiD;
    • had early relapse after initial treatment. Early relapse is defined by at least one of the following: (Relapse is defined as the IMWG uniform response criteria (Kumar et al, 2016);
    • Within 3 years of initiation of induction chemotherapy for post ASCT followed by maintenance, or 18 months if unmaintained after ASCT;
    • Within 18 months of initial non-ASCT based therapy.
  • Patients must have progressed after their most recent treatment and require therapy for myeloma.
  • The following laboratory values obtained ≤ 14 days prior to registration:
    • ANC ≥ 1000/ul;
    • Hgb ≥ 8 g/dl;
    • PLT ≥ 75,000/ul (Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days prior to study drug dosing for any dosing day);
    • Total bilirubin < 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN, the direct bilirubin must be ≤ 2.0 mg/dL;
    • AST < 3 x ULN;
    • Creatinine Clearance ≥ 30 mL/min by Cockroft Gault Equation.
  • Measurable disease of MM as defined by at least ONE of the following:
    • Serum monoclonal protein ≥ 0.5g by protein electrophoresis;
    • ≥ 200 mg of monoclonal protein in the urine on 24-hour electrophoresis;
    • Serum immunoglobulin FLC ≥10 mg/dL AND abnormal serum immunoglobulin kappa to lambda FLC ratio;
    • Monoclonal bone marrow plasmacytosis ≥30% (evaluable disease).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2.
  • Willingness to return to enrolling institution for follow-up.
  • Disease free of prior malignancies for ≥ 3 year with exception of currently treated basal cell, squamous cell carcinoma of the skin, carcinoma “insitu” of the cervix or breast, or prostate cancer not requiring therapy.
  • Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).
  • All study participants must be willing to be registered into the mandatory pomalidomide (POMALYST®) Risk Evaluation and Mitigation Strategy (REMS®) program and be willing and able to comply with the requirements of the POMALYST REMS® program.
  • Females of reproductive potential* must be willing to adhere to the scheduled pregnancy testing as required in the POMALYST REMS® program.
  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent form (ICF) and authorization to use protected health information.

*Female of reproductive potential is any sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy, or 2) has not been naturally postmenopausal (not having menstrual cycles due to cancer therapy does not rule out childbearing potential) for at least 24 consecutive months.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Jeremy Larsen, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Shaji Kumar, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

  • Treatment of multiple myeloma has substantially changed over the past decade with the introduction of several classes of new effective drugs that have greatly improved the rates and depth of response. Response criteria in multiple myeloma were developed to use serum and urine assessment of monoclonal proteins and bone marrow assessment (which is relatively insensitive). Given the high rates of complete response seen in patients with multiple myeloma with new treatment approaches, new response categories need to be defined that can identify responses that are deeper than those conventionally defined as complete response. Recent attempts have focused on the identification of residual tumour cells in the bone marrow using flow cytometry or gene sequencing. Furthermore, sensitive imaging techniques can be used to detect the presence of residual disease outside of the bone marrow. Combining these new methods, the International Myeloma Working Group has defined new response categories of minimal residual disease negativity, with or without imaging-based absence of extramedullary disease, to allow uniform reporting within and outside clinical trials. In this Review, we clarify several aspects of disease response assessment, along with endpoints for clinical trials, and highlight future directions for disease response assessments. Read More on PubMed

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions