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Randomized phase 2 trial of ixazomib and dexamethasone in relapsed multiple myeloma not refractory to bortezomib

Shaji K. Kumar, Betsy R. LaPlant, Craig B. Reeder, Vivek Roy, Alese E. Halvorson, Francis Buadi, Morie A. Gertz, P. Leif Bergsagel, Angela Dispenzieri, Melanie A. Thompson, Jamie Crawley, Prashant Kapoor, Joseph Mikhael, Keith Stewart, Suzanne R. Hayman, Yi L. Hwa, Wilson Gonsalves, Thomas E. Witzig, Sikander Ailawadhi, David Dingli, Ronald S. Go, Yi Lin, Candido E. Rivera, S. Vincent Rajkumar and Martha Q. Lacy

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  • RE: Randomized phase 2 trial of ixazomib and dexamethasone in relapsed multiple myeloma not refractory to bortezomib

    This trial was not designed to prove that the efficacy or toxicity is different for the two doses, but was done to generate hypotheses that can be tested in larger confirmatory trials. The discussion reflects this and is prefaced with the statement “The study was not designed to formally compare the 2 dose levels in terms of efficacy or toxicity”. This should be adequate for the average reader to appreciate the intent of the trial. In terms of the response rate, the statement clearly states that the 63% response rate is for the bortezomib and dexamethasone, and there is no ambiguity in this statement. We appreciate the typos (103 instead of 1-3 and phase 3 instead of phase 2) pointed out by the diligent reader.

    Submitted on behalf of all the co-authors: Betsy R. LaPlant, Craig B. Reeder, Vivek Roy, Alese E. Halvorson, Francis Buadi, Morie A. Gertz, P. Leif Bergsagel, Angela Dispenzieri, Melanie A. Thompson, Jamie Crawley, Prashant Kapoor, Joseph Mikhael, Keith Stewart, Suzanne R. Hayman, Yi L. Hwa, Wilson Gonsalves, Thomas E. Witzig, Sikander Ailawadhi, David Dingli, Ronald S. Go, Yi Lin, Candido E. Rivera, S. Vincent Rajkumar and Martha Q. Lacy

    Conflict of Interest:
    None declared.
  • RE: Randomized phase 2 trial of ixazomib and dexamethasone in relapsed multiple myeloma not refractory to bortezomib
    • Anil K Tripathi, Professor and Head of Department,Department of Clinical Hematology King George's Medical University
    • Other Contributors:
      • Shailendra P Verma, Assistant Professor, Department of Clinical Hematology
      • Avriti Baveja, Senior Resident, Department of Clinical Hematology
      • Sudhir Kumar, Senior Resident, Department of Clinical Hematology
      • Nidhish Kumar, Senior Resident, Department of Clinical Hematology

    In the article “Randomized phase 2 trial of ixazomib and dexamethasone in relapsed multiple myeloma not refractory to bortezomib” published in Blood (2016;128:2415-2422), Authors have concluded that ixazomib in combination with dexamethasone has promising activity in relapsed myeloma, along with a favorable toxicity profile.1 We would like to point out certain ambiguity in the description given in the “Discussion”.
    In second paragraph, page 2421 it says “The ORR with bortezomib and dexamethasone was 63% in the Phase 3 study With Carfilzomib and Dexamethasone Versus Bortezomib and Dexamethasone for Relapsed Multiple Myeloma patients (ENDEAVOR) trial, 2 but this was a relatively less treated group of patients with 103 prior treatment compared with the median of 4 prior therapies in the current trial. The PFS was 9.4 months in the ENDEAVOR trial compared with approximately 6 months in the current phase 3 trial.”
    In above lines, it is not clear, possibly due to error in punctuation, whether ORR of 63% is reported with Carfilzomib and Dexamethasone combination or with Bortezomib and Dexamethasone combination.
    “with 103 prior” should be read as “with 1-3 prior” .
    “current phase 3 trial” should be “current phase 2 trial”
    Furthermore, the last lines in the study objectives read “The study was not designed to formally compare the 2 dose levels in terms of efficacy or toxicity.” However, it is obvious from the results and discussion of paper that the s...

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    Conflict of Interest:
    None declared.