A Trial Evaluating Efficacy & Safety of RVD +/- Panobinostat in Transplant Eligible, Newly Diagnosed Multiple Myeloma (NDMM)

Overview

This is a randomized, phase II trial evaluating the efficacy and safety of lenalidomide, bortezomib and dexamethasone (RVD) with or without panobinostat in transplant eligible, newly diagnosed multiple myeloma.

SparkCures ID 823
Trial Phase Phase 2
Enrollment 112 Patients
Treatments
Trial Sponsors
  • Novartis
NCT Identifier

NCT02720510

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • Patient must be newly diagnosed with multiple myeloma, based on following IMWG 2014 definition (Rajkumar et al 2014):
  • Clonal bone marrow plasma cells ≥ 10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following myeloma defining events:
  • Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder
  • Any one or more of the following biomarkers of malignancy:
    1. Clonal bone marrow plasma cell percentage ≥ 60%
    2. Involved: uninvolved serum free light chain ratio ≥ 100
    3. >1 focal lesions on MRI studies
  • Patient must have measurable disease defined by at least 1 of the following conditions present at screening:
  • Serum M-protein by Protein Electrophoresis (PEP) ≥ 1.0 g/dL (≥ 10 g/L).
  • Urine M-protein by PEP ≥ 200 mg/24 hours. Involved serum free light chain level ≥ 10 mg/dL (≥ 100 mg/L), provided that the serum free light chain ratio is abnormal.
  • Patient must be eligible for autologous stem cell transplantation based on the investigator's clinical judgment.
  • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
  • Patient's age is ≥ 18 and <75 years at time of signing the informed consent
  • Patient has provided written informed consent prior to any screening procedures
  • Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline

Exclusion Criteria:

Patients eligible for this study must not meet any of the following criteria:

  • Any concomitant anti-cancer therapy (other than bortezomib/lenalidomide/dexamethasone; bisphosphonates are permitted only if commenced prior to the start of screening period)
  • Unresolved diarrhea ≥ CTCAE grade 2 or presence of medical condition associated with chronic diarrhea (such as irritable bowel syndrome, inflammatory bowel disease).
  • Allogeneic stem cell transplant recipient presenting with graft versus host disease either active or requiring immunosuppression
  • Patient has shown intolerance to bortezomib or to dexamethasone or components of these drugs or has any contraindication to one or the other drug, following locally applicable prescribing information
  • Patient has grade ≥ 2 peripheral neuropathy or grade 1 peripheral neuropathy with pain on clinical examination at screening
  • Patient received prior treatment with DAC inhibitors including Panobinostat
  • Patient needing valproic acid for any medical condition during the study or within 5 days prior to first administration of panobinostat/study treatment.
  • Patient taking any anti-cancer therapy concomitantly (bisphosphonates are permitted only if commenced prior to the start of screening period)
  • Patient who received:
    1. prior anti-myeloma chemotherapy or medication including Immunomodulator (IMiDs) and Dex ≤ 3 weeks prior to start of study.
    2. experimental therapy or biologic immunotherapy including monoclonal antibodies ≤ 4 weeks prior to start of study.
    3. prior radiation therapy ≤ 4 weeks or limited field radiotherapy ≤ 2 weeks prior start of study.
  • Patient has not recovered from all therapy-related toxicities associated with above listed treatments to < grade 2 CTCAE.
  • Patient has undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy to < grade 2 CTCAE
  • Patients with evidence of mucosal or internal bleeding
  • Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 month prior to screening)
  • Inability to determine the Fridericia's Correction Formula (QTc) F interval
  • Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of panobinostat (e.g. ulcerative disease, uncontrolled nausea, vomiting, malabsorption syndrome, obstruction, or stomach and/or small bowel resection)
  • Sexually active males unless they use a condom during intercourse while taking the drug during treatment, and for 6 months after stopping treatment
  • Pregnant or nursing (lactating) women.

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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