Clinical Trials /

Steroid Sparing Treatment With in Newly Diagnosed Transplant Ineligible Patients With Multiple Myeloma

NCT04635189

Description:

The purpose of this study is to determine the effects of daratumumab and lenalidomide without steroids for treating patients with multiple myeloma.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Steroid Sparing Treatment With in Newly Diagnosed Transplant Ineligible Patients With Multiple Myeloma
  • Official Title: A Phase II Study of Steroid Sparing Treatment With Daratumumab and Lenalidomide in Newly Diagnosed Transplant Ineligible Patients With Multiple Myeloma

Clinical Trial IDs

  • ORG STUDY ID: UMMY20033
  • NCT ID: NCT04635189

Conditions

  • Multiple Myeloma

Interventions

DrugSynonymsArms
DaratumumabDarzalexExperimental Arm: Cycle 1-4 All subjects
LenalidomideRevlimidExperimental Arm: Cycle 1-4 All subjects
DexamethasoneOzurdexExperimental Arm: Cycle 1-4 All subjects

Purpose

The purpose of this study is to determine the effects of daratumumab and lenalidomide without steroids for treating patients with multiple myeloma.

Detailed Description

      This is an open label, phase 2 study consisting of daratumumab, lenalidomide and
      dexamethasone, given upfront in newly diagnosed, transplant ineligible patients with myeloma.
      Patients participating in the study will be recruited from the Wilmot Cancer Institute,
      University of Rochester in Rochester, New York and all University of Rochester community
      affiliates.

      Patients will be treated with 1800 milligrams of Daratumumab subcutaneously or 16
      milligrams/kilograms daratumumab intravenously (IV) weekly for 8 treatments, followed by
      every 2 weeks for 8 treatments, followed by every 4 weeks. Patients will be treated with 25
      milligrams of Lenalidomide days 1-21 out of a 28 day cycle (dose adjustments for creatinine
      clearance) and 20 milligrams of Dexamethasone at least 60 minutes prior to first infusion of
      daratumumab. Each cycle consists of 28 days (4 weeks).

      Response assessments by International Myeloma Working Group criteria for myeloma will be
      performed every 4 weeks while on therapy.
    

Trial Arms

NameTypeDescriptionInterventions
Experimental Arm: Cycle 1-4 All subjectsActive ComparatorSubjects will be treated with the following: Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle Dexamethasone 20 milligrams by mouth or intravenously at least 60 minutes prior to first infusion of daratumumab
  • Daratumumab
  • Lenalidomide
  • Dexamethasone
Experimental Arm: Cycle 5+ Partial Response or BetterExperimentalSubjects will be treated the following: Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks Lenalidomide 25 milligrams/kilograms daily days 1-21 out of a 28 day cycle
  • Daratumumab
  • Lenalidomide
Experimental Arm: Cycle 5+ Less than Partial ResponseActive ComparatorSubjects will be treated the following: Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle Dexamethasone 20 milligrams by mouth or intravenously at least 60 minutes prior to first infusion of daratumumab
  • Daratumumab
  • Lenalidomide
  • Dexamethasone

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of multiple myeloma with diagnosis

          -  Must not have received previous therapy for multiple myeloma

          -  Newly diagnosed and not considered candidate for high-dose chemotherapy

          -  Adequate organ system function

          -  A performance status ≤ 3

          -  Ability to swallow and retain oral medication

          -  Female subjects of child bearing potential must be surgically sterile, be
             post-menopausal

        Exclusion Criteria:

          -  A diagnosis of primary amyloidosis; monoclonal gammopathy of undetermined
             significance, smoldering multiple myeloma; non-secretory myeloma

          -  A diagnosis of Waldenström's disease

          -  Receiving cancer therapy

          -  Radiation therapy within 14 days of enrollment

          -  Major surgery within 2 weeks before enrollment

          -  Human immunodeficiency virus -infected patients must be on effective anti-retroviral
             therapy with undetectable viral load within the past 6 months

          -  Seropositive for hepatitis B, or seropositive for hepatitis C

          -  Ongoing systemic bacterial, fungal or viral infection

          -  Severe and/or uncontrolled medical conditions

          -  Malignancy within 2 years of study enrollment

          -  Women who are pregnant or lactating

          -  Contraindications to required prophylaxis for deep vein thrombosis and pulmonary
             embolism.
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Daratumumab Related Infusion Reactions
Time Frame:28 days
Safety Issue:
Description:To determine the rate of daratumumab related infusion reactions in patients treated for myeloma without steroids compared to historical controls.

Secondary Outcome Measures

Measure:Determination of Response Rates
Time Frame:28 days
Safety Issue:
Description:To determine the proportion of patients who do not achieve at least a partial response after 4 cycles and require steroids to be added back to their regimen

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of Rochester

Last Updated

July 29, 2021