A Phase II Clinical Trial of Lenalidomide Intensification in Patients with Serologic/Asymptomatic Progression of Multiple Myeloma While on Lenalidomide Maintenance after Autologous Stem Cell Transplantation

Study Status

Open to Enrollment

Study Description

This is a clinical trial for patients with multiple myeloma who:

  • Have been treated in the past with autologous stem cell transplant
  • Are currently taking Lenalidomide maintenance
  • Their physician recently determined their disease has returned via a rising paraprotein (either M-spike or free light chain) in either the blood or the urine
  • Have no symptoms and no organ damage from the disease at this time

The purpose of this study is to determine if your multiple myeloma will get better if treated with higher doses of Lenalidomide if the blood or urine markers for the disease rise while you were taking low doses of Lenalidomide. In all patients with multiple myeloma treated with autologous stem cell transplant followed by low dose Lenalidomide, the disease will eventually return. However, we currently do not know if a return the disease would respond to treatment with higher doses of Lenalidomide.

Patients will take Lenalidomide every day for 3 weeks (days 1 to 21) followed by 1 week off medicine (days 22 to 28) in a 28-day treatment cycle. Patients will be given a diary to keep track of when they take the medicine and how many capsules they take. Patients will return to the clinic after every cycle for blood tests and examination.

At the end of 2 cycles, your doctor will determine how your myeloma is responding to the treatment. If your disease is stable or improved, you will continue Lenalidomide treatment indefinitely. If at some point the disease gets worse, your doctor will prescribe another medication called dexamethasone along with the Lenalidomide.

Patients will take Lenalidomide or Lenalidomide and dexamethasone indefinitely until disease progression or unable to tolerate the side effects.

Key eligibility:

  • Men and women age 18 or older
  • Multiple myeloma
  • Asymptomatic relapse and/or progression of disease while on Lenalidomide maintenance after autologous stem cell transplant
  • Detailed eligibility reviewed when you contact the study team

Linda Tegnestam, R.N.
Email: lit2011@med.cornell.edu
Phone: (212) 746-1480

Kathleen Pogonowski, R.N.
Email: kap9111@med.cornell.edu
Phone: (212) 746-6738

Disease Status and/or Stage

Progression of Multiple Myeloma

Sponsor

Celgene; Memorial Sloan Kettering Cancer Center

Principal Investigator

Tomer Mark, M.D.

Protocol ID

WCMC IRB #1202012181


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Contact Us

For general inquiries, or if you need assistance finding a study, please e-mail:
Erica Bersin
Manager, Subject Recruitment & Communications
(646) 962-8232
erb3001@med.cornell.edu
jcto.weill.cornell.edu

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