NCI Community Oncology Research Program - Kansas City (NCORP-KC)
NCI Community Oncology Research Program - Kansas City (NCORP-KC)




NCI Community Oncology Research Program - Protocol Summary

ALLIANCE A061202 - "A Phase I/II Study of Pomalidomide, Dexamethasone and Ixazomib Vs. Pomalidomide and Dexamethasone for Patients with Multiple Myeloma Relapsing on Lenalidomide as Part of First Line Therapy"

The summary below serves as a brief review of the treatment plan and eligibility for the protocol.


This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
 

Please contact NCORP-KC for complete protocol information.



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Myeloma Clinical Trial

CANCER TYPE: Myeloma
RESEARCH BASE: Alliance
NCT NUMBER: NCT02004275
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UPDATED ON 09/26/2018 (20:37:28)

BRIEF DESCRIPTION

MM refractory to lenalidomide and proteasome inhibitor-based therapy; pomalidomide/dexamethasone/ixazomib vs. pomalidomide/dexamethasone



NOTES


Treatment Plan      (Supplied Drug:  Pomalidomide and Ixazomib)

Protocol treatment is to begin ≤ 7 days of registration.

1 cycle = 28 days

Phase II

Arm 1

Course 1

Pomalidomide:  4mg orally daily for days 1-21.

Dexamethasone:  Patients < 75 years of age, 40mg orally on days 1,8,15,22.

                          Patients over 75 years of age, 20mg orally on days 1,8,15,22.

Course 2 (Following progression on Course 1 treatment, patients in Arm 1 may opt to receive Course 2 treatment. These patients must be re-registered to the study prior to starting Course 2.)

Pomalidomide:  Dose tolerated in Course 1, Orally, Days 1 – 21

Dexamethasone: Dose tolerated in Course 1, Orally, Days 1, 8, 15, and 22

Ixazomib:  4 mg, Orally, Days 1, 8, and 15

 

Arm 2

Pomalidomide:  4mg orally daily for days 1-21.

Dexamethasone:  Patients < 75 years of age, 40mg orally on days 1,8,15,22.

                          Patients over 75 years of age, 20mg orally on days 1,8,15,22.

Ixazomib:  4mg, administered orally on days 1,8,15.

 

 

  • Given the increased risk of venous thromboembolic events with the use of pomalidomide and dexamethasone, thromboprophylaxis is required while patients are on protocol therapy and should consist of either aspirin (81 mg or 325 mg), a prophylactic dose of low molecular weight heparin (e.g. enoxaparin 40 mg SC daily) or warfarin targeting an INR of 2 – 3, or other equivalent.
  • Hold dexamethasone, pomalidomide and ixazomib if radiation therapy is performed, treatment can resume as soon as radiation therapy is complete.
  • TX will continue until disease progression or unacceptable toxicity.

 



ELIGIBILITY

  • Histologically confirmed diagnosis of symptomatic multiple myeloma.
  • Measurable disease:
    • Serum M-protein ≥1.0 g/dL (≥0.5 g/dL for IgA or IgM myeloma) and/or
    • Urine M-protein ≥200 mg/24 hours and/or
    • Involved serum free light chain level ≥10 mg/dL AND an abnormal serum free light chain ratio and/or
    • For non-measurable disease:  Baseline marrow burden of myeloma of at least 30%
  • Prior Treatment
    • Progression on lenalidomide as part of first line therapy (lenalidomide-refractory disease)
    • Pomalidomide naïve disease
    • Proteasome inhibitor naïve or sensitive disease.
    • 1 prior line of systemic therapy for multiple myeloma, where a line of therapy for myeloma is defined as 1 or more planned cycles of single agent or combination therapy, as well as a planned series of treatment regimens administered in a sequential manner (e.g. lenalidomide, bortezomib and dexamethasone induction therapy for 4 cycles followed by autologous stem cell transplantation and then lenalidomide maintenance therapy would be considered 1 line of prior therapy).
    • Allogeneic stem cell transplantation is allowed provided the patient is ≥ 1 year from transplant at time of registration, is not on immunosuppressive therapy to treat/prevent graft-versus-host disease, has no evidence of active graft versus host disease, and no evidence of active infection.
    • No chemotherapy or radiation therapy within 14 days prior to registration.
    • No investigational therapy within 14 days prior to registration.
    • No major surgery within 28 days prior to registration.
    • No G-CSF (Filgrastim) or GM-CSF (Sargramostim) within 7 days of registration or Pegfilgrastim within 14 days of registration to meet eligibility criteria.
    • No platelet transfusions within 7 days of registration to meet eligibility criteria. Note: Red blood cell transfusions are allowed at any time.
  • Non-pregnant and non-nursing
  • ≥18 years of age
  • ECOG Performance status 0-2
  • Required Initial Laboratory Values:
    • Absolute Neutrophil Count (ANC) ≥ 1.0 x 109/L
    • Platelet Count ≥ 50 x 109/L
    • Calc. Creatinine Clearance ≥ 30 mL/min
    • Total Bilirubin < 1.5 x upper limits of normal (ULN)
    • AST and ALT < 2.5 x upper limits of normal (ULN)
    • Note: G-CSF and platelet transfusions cannot be used to increase counts to meet eligibility criteria.
  • Intercurrent or Recent Illness.  Patients cannot have:
    • Central nerve system involvement
    • Primary refractory multiple myeloma
       Note: primary refractory multiple myeloma is defined as disease that is nonresponsive – patients who have never achieved an MR or better – with any therapy over the course of their disease. It includes patients who never achieve MR or better in whom there is no significant change in M-protein and no evidence of clinical progression as well as patients who meet criteria for true progressive disease (PD).
    • Primary or secondary plasma cell leukemia
    • AL amyloidosis or POEMS syndrome
    • Known active hepatitis C based on:
      • +HCV antibody (confirmed)
      • +HCV RNA
      • Liver disease with history of positive serology
    • Known hepatitis B surface antigen positivity
    • Patients cannot have had previous hypersensitivity to any of the components of the study treatment
    • Patients cannot have had a prior history of erythema multiforme with thalidomide or lenalidomide treatment
  • ≤ Grade 2 Peripheral Neuropathy
  • Adequate cardiac function, defined as:
    • No EKG evidence of acute ischemia
    • No EKG evidence of active, clinically significant conduction system abnormalities
    • No EKG evidence of >Grade 2 (>480 ms) QTc prolongation
    • Prior to study entry, any EKG abnormality at screening not felt to put the patient at risk has to be documented by the investigator as not medically significant
    • No uncontrolled angina or severe ventricular arrhythmias
    • No clinically significant pericardial disease
    • No history of myocardial infarction within the last 6 months
    • No Class 3 or higher New York Heart Association Congestive Heart Failure
  • No strong inducers of cytochrome P450 (CYP) 3A4 or CYP1A2 or strong inhibitors of CYP3A4 or CYP1A2 within 14 days prior to registration.
  • Patients with HIV infection are eligible, provided they meet the following:
    • No history of AIDS-defining conditions or other HIV related illness
    • CD4+ cells nadirs >350/mm3 within 28 days prior to registration
    • Treatment sensitive HIV and, if on anti-HIV therapy, HIV viral load < 50 copies/mm3 within 28 days prior to registration
    • Please note: HIV+ patients who enroll on this study and are assigned to treatment with ixazomib may need to modify their anti-retroviral therapy prior to receiving protocol therapy if they are on strong inducers or potent inhibitors of cytochrome P450 3A4 (see section 3.2.4h).





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