Dana-Farber / Brigham and Women's Cancer Center

National Trial Evaluates Novel Approach for Younger Adults with Newly Diagnosed Multiple Myeloma

Drs. Anderson, Richardson and Munshi

Hemato-oncologists in the Jerome Lipper Multiple Myeloma Center at Dana-Farber/Brigham and Women’s Cancer Center are leading a national clinical trial for younger adult patients newly diagnosed with multiple myeloma (MM).

This randomized Phase III trial (DFCI#10-106) is comparing the efficacy and side effects of a novel drug combination – lenalidomide, bortezomib, and dexamethasone (RVD) – used alone or when combined with high-dose chemotherapy supported by autologous stem cell transplantation (HDC/ASCT) in patients with newly diagnosed multiple myeloma. While HDC/ASCT has historically been the mainstay of treatment for these patients, it has not been clear if all patients benefitted from this potentially toxic modality as part of their treatment. The primary measure of success in this trial will be improvement in progression-free survival by nine months or more for the RVD+HDC/ASCT early arm, compared to the other, where HDC/ASCT is kept in reserve. Consolidation and maintenance are used in both arms.

“Through ongoing research, we are seeing rapidly emerging new standards of care for patients with multiple myeloma,” said Principal Investigator Paul G. Richardson, MD, Clinical Director of the Jerome Lipper Multiple Myeloma Center. “We are now moving away from a one-size-fits-all mentality to look at tailored treatments for patients, and the key question in this current trial is who is best served by one approach, versus the other.”

Previous Success

A previous study of RVD among newly diagnosed multiple myeloma patients, also led by the same researchers at Dana- Farber/Brigham and Women’s Cancer Center, demonstrated an unprecedented overall partial response rates of 100 percent, including 40 percent complete response and near complete response (Blood. 2010 Aug 5;116(5):679-86.). This was also associated with a favorable side effect profile and encouraging long-term outcome, where clinical benefit proved similar for both patients who subsequently received HDC/ASCT and those who did not (see Figure 1).

Figure 1

Genetic Profiling

Genomic studies including gene expression profiling and whole genome sequencing, conducted by Nikhil Munshi, MD, Associate Director of the Jerome Lipper Multiple Myeloma Center and lead investigator for Correlative Science, and senior investigator Kenneth Anderson, MD, Director of the Jerome Lipper Multiple Myeloma Center, is critical to the study and will complement current standards, including cytogenetics.

“The genomic studies will allow us to identify sensitive markers of response versus resistance to treatment and will provide us with clues on how to develop personalized medicine in myeloma,” said Dr. Munshi.

Eligibility Criteria

Approximately 660 patients across 60 study sites in the United States are being enrolled in the trial, which is expected to remain open until mid-2015. Major eligibility criteria include:

  • Adults up to 65 years of age with documented symptomatic multiple myeloma, confirmed by laboratory assessments performed within 21 days of study registration;
  • Myeloma measurable by either serum or urine evaluation of the monoclonal component or by assay of serum free light chains;
  • ECOG Performance Status < 2;
  • Negative HIV blood test.

    “This trial examines the role of high-dose therapy and transplantation in the era of novel therapies,” said Dr. Anderson. “It will better define the genetic heterogeneity of myeloma at diagnosis, define mechanisms of relapse to inform improved salvage therapies, and ultimately provide for a new standard of care in myeloma.”

Information and Access

For more information regarding the Jerome Lipper Multiple Myeloma Center at Dana-Farber/Brigham and Women’s Cancer Center, or to refer a patient, please call 1-877-332-4294 to speak with one of our experienced referral coordinators. For more information on the 10-106 clinical trial, or to discuss a patient who may be eligible, please contact Principal Investigator Paul G. Richardson, MD, at (617) 632-2127 or [email protected]

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