New Clinical Trial: Ofatumumab and Bortezomib in Untreated Waldenstrom Macroglobulinemia

A Multicenter Phase II Study of Ofatumumab and Bortezomib (OB) in Previously Untreated Patients with Waldenström Macroglobulinemia

This study is ongoing, but not recruiting participants.

The Weill Cornell Lymphoma Program is now enrolling patients in a new clinical trial for people with Waldenstrom Macroglobulinemia who have not been treated. The study sponsor is the National Comprehensive Cancer Network (NCCN). The principal investigator at Weill Cornell is Dr. Peter Martin.

For more information about the study, please call Amelyn Rodriguez, RN at (212) 746-1362 or email Amelyn at amr2017@med.cornell.edu.

Key Eligibility

  • Men and women age 18 and older
  • Diagnosis of Waldenstrom Macroglobulinemia (WM)
  • No prior anti-neoplastic therapy for WM
  • Detailed eligibility reviewed when you contact the study team

Study Details

Although there is currently no standard treatment for first-line management of WM, most clinicians and investigators believe that anti-CD20 directed therapy should compromise part of the regimen. Because it was the first therapeutic monoclonal antibody approved by the FDA , rituximab has been evaluated more than any antibody and has shown modest effects with limited toxicity. However, new treatments for WM are needed.

Ofatumumab has been approved for treatment of relapsed/refractory Chronic Lymphocytic Leukemia (CLL). It is an anti-CD20 monoclonal antibody that compared favorably to rituximab in a recent Phase 2 trial in patients with WM.

The purpose of the study is to determine how well previously untreated people with Waldenstrom Macroglobulinemia respond to treatment with ofatumumab in combination with bortezomib (Velcade). The study will also evaluate the safety of ofatumumab in combination with bortezomib.

Treatment Plan

Study participants will have four 28-day cycles of induction phase therapy. Participants will receive treatments weekly for three weeks, and then have a rest period (no treatment) for the fourth week. After the four cycles, there will be 4 weeks of no therapy and then 4 cycles of maintenance phase therapy. The maintenance cycles will be 28 days long. Participants will receive three weeks of treatment, then a resting period (no treatment) for the fourth week. This will be followed by four weeks of rest (no treatments). Then a new cycle will begin. Thus a new cycle of maintenance treatment will begin every 8 weeks. The entire period for both induction and maintenance therapy will be 1 year (52 weeks).

Participants will be followed until disease progression or 5 years from study entry, whichever comes first.


New Weill Cornell Study: Thalidomide and Lenalidomide + Rituximab (ThRiL) for Previously Treated Waldenstrom Macroglobulinemia

A Phase 2 Trial of Daily Alternating Thalidomide and Lenalidomide Plus Rituximab (ThRiL) for Patients with Previously Treated Waldenstrom Macroglobulinemia

Update: this study is closed to enrollment. 

The Weill Cornell Lymphoma Program is now enrolling patients in a newly opened, investigator-initiated clinical trial for people with previously treated Waldenstrom Macroglobulinemia. The principal investigator is Peter Martin, MD.

For more information about the study, please call Amelyn Rodriguez, RN at (212) 746-1362 or email Amelyn at amr2017@med.cornell.edu.

Key eligibility

  • Previously treated for Waldenstrom Macroglobulinemia
  • Not currently treated with other anti-cancer agents or treatments
  • No prior treatment with thalidomide or lenalidomide
  • Detailed eligibility reviewed when you contact the study team

Study Details

The study is evaluating the efficacy and safety of daily alternating thalidomide and lenalidomide plus rituximab (ThRiL) in people with previously treated Waldenstrom Macroglobulunemia (WM).

Thalidomide and lenalidomide are drugs that modulate the immune system and have been shown to bring about responses in patients with WM. However, their use has been limited due to side effects. Alternating doses of thalidomide and lenalidomide may alleviate the side effects while preserving the effectiveness of the therapies.

Treatment Plan

  • Thalidomide every ODD day of a 28 day cycle
  • Lenalidomide every EVEN day of a 28 day cycle
  • Rituximab on Days 1, 8, 15 and 22 and then again on the same weekly x 4 schedule every 6th cycle thereafter (Cycles 7, 13, 19, etc)

Study participants may continue to receive thalidomide and lenalidomide until their disease worsens.


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