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Clinical Trial 19360

Cancer Type:
Interventions:CC-5013 (Lenalidomide); Daratumumab; Dexamethasone; Lenalidomide (Revlimid); carfilzomib (Kyprolis)

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Melissa Alsina

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

Aggressive Smoldering Curative Approach Evaluating Novel Therapies and Transplant (ASCENT): A Phase 2 Trial of Induction, Consolidation and Maintenance in Subjects with High Risk Smoldering Multiple Myeloma (SMM)

Summary

This study evaluates the use of carfilzomib, lenalidomide, daratumumab, and dexamethasone in patients with high-risk smoldering multiple myeloma (SMM).

Objective

Primary Objective 1.To determine the persistent MRD negativity rate at two years following the completion of intense induction, consolidation and maintenance treatment in subjects with high risk smoldering multiple myeloma. Secondary Objective 1. To determine the MRD negativity rate at the end of induction, end of consolidation, end of maintenance and at two years after the completion of treatment. 2. To determine the progression free survival and overall survival rate 3. To determine the toxicities associated with this treatment approach in subjects with high risk SMM Correlative Research 1. To determine the clonal architecture before treatment, after treatment in subjects with residual disease and in subjects who have disease progression after attaining MRD negativity. 2. To evaluate the bone marrow microenvironment before and after treatment and the time of MRD negative state

Inclusion Criteria

> Age ≥18 years and ≤80 years

  • High risk smoldering myeloma, which is untreated, as defined by: Serum M spike > 3 gm/dL AND an involved to uninvolved FLC ratio > 8 AND bone marrow PC% ≥ 10%
  • Adequate organ function
  • Prior therapy for the treatment of solitary plasmacytoma is permitted, but >7 days should have elapsed from the last day of radiation. NOTE: Prior therapy with clarithromycin, DHEA, anakinra, pamidronate or zoledronic acid is permitted. Any additional agents not listed must be approved by the Principal Investigator.
  • Measurable disease as defined by at least ONE of the following: ¿ Serum monoclonal protein ≥1.0 g/dL (see Section 11.1 for definition)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Previously untreated.
  • Able to understand and provide informed written consent.
  • Negative pregnancy test done ≤7 days prior to C1D1, for women of childbearing potential only.
  • All study participants must be registered into the mandatory Revlimid REMS® program and be willing and able to comply with the requirements of the REMS® program.
  • Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.
  • Women of childbearing age and males must adhere to contraception guidelines.
  • Willing to return to enrolling institution for follow-up during the Active Treatment Phase of the trial.
  • Willing to provide samples for planned research
  • Life expectancy > 6 months
  • Able to take aspirin (325 mg) daily as prophylactic anticoagulation. Subjects intolerant to aspirin may use warfarin or low dose molecular weight heparin.

    • Exclusion Criteria

    > MGUS, standard risk smoldering myeloma, active myeloma by current IMWG definition, light chain amyloidosis with organ involvement or patients with extramedullary disease.

  • Diagnosed or treated for another malignancy ≤ 2 years before trial enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Exclusions may apply.
  • Pregnant or nursing women
  • Men or women of childbearing potential (WOCP) who are unwilling to employ adequate contraception per protocol.
  • Other co-morbidity which would interfere with subject's ability to participate in trial.
  • Other concurrent chemotherapy, or any ancillary therapy considered investigational. Exclusions may apply.
  • Peripheral neuropathy ≥ Grade 3 on clinical examination or grade 2 with pain within 30 days prior to C1D1.
  • Major surgery ≤14 days prior to first day of treatment.
  • Evidence of current uncontrolled cardiovascular conditions within the past 6 months.
  • NYHA II, III, IV heart failure
  • Known human immunodeficiency virus (HIV) positive.
  • Known hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection.
  • Any medical or psychiatric illness that could, in the investigator¿s opinion, potentially interfere with the completion of treatment according to this protocol.
  • Prior radiation therapy for bony lesions or plasmacytomas
  • Known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients.
  • Inability to comply with protocol/procedures.

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