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An Open-Label Phase I/II Study of Bendamustine, Weekly Bortezomib, Lenalidomide and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

Thank you

Trial Information

An Open-Label Phase I/II Study of Bendamustine, Weekly Bortezomib, Lenalidomide and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma


Multiple myeloma is a multi-organ neoplastic disorder caused by the clonal proliferation of
plasma cells. It has an incidence of about 4.5/100,000 per year in the U.S., making it the
second most common hematologic malignancy. For many years, alkylating agents have been the
backbone of treatment. The combination of melphalan and prednisone was, for many years, the
standard of care for patients who were not candidates for autologous transplantation.
Melphalan continues to be the primary conditioning agent for autologous transplant,and
cyclophosphamide has also gained a foothold in the treatment of this disease.

The introduction of novel agents has fundamentally changed the landscape of treating this
disease, although the true effects on survival are not yet known. Immunomodulatory agents
and proteosome inhibitors, including thalidomide, lenalidomide and bortezomib, have been
used in both newly diagnosed and relapsed patients. Currently, there is intense clinical
research on the optimal way to combine these novel agents with the traditional backbones of
treatment - including alkylators, with one another and, eventually, with the subsequent
iterations of these classes of drugs. However, despite the therapeutic excitement
surrounding this disease, nearly all patients will relapse, and cure remains an elusive goal
for all but a rare handful.


Inclusion Criteria:



- Adults with relapsed and/or refractory myeloma who have received between 1-4 prior
lines of therapy

- must have adequate liver and renal function

- ZPS of 2 or better

- must have measurable disease

Exclusion Criteria:

- Peripheral neuropathy of grade II or higher

- Thrombocytopenia (platelets less than 50,000/uL)

- Neutropenia (ANC<1000/uL)

- AST or ALT >2.4 X ULN

- Total bilirubin >1.5 X ULN

- Creatinine clearance of less than 60mL/min (Phase I) and of 40mL/min or less (Phase
II)

- Patients with HIV

- Patients with active hepatitis

- Pregnant or lactating women

- Individuals of child-bearing potential not using adequate contraception

- Individuals unable to provide informed consent

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximally Tolerated Dose of Bendamustine

Outcome Description:

Primary objective of this phase is to determine the MTD of bendamustine when combined with bortezomib, lenalidomide and dexamethasone in subjects with relapsed and/or refractory multiple myeloma.

Outcome Time Frame:

21 days

Safety Issue:

Yes

Principal Investigator

Laura Michaelis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Loyola Univ Med Cntr - Cardinal Bernardin Cancer Cntr

Authority:

United States: Food and Drug Administration

Study ID:

203145

NCT ID:

NCT01484626

Start Date:

May 2011

Completion Date:

May 2015

Related Keywords:

  • Multiple Myeloma
  • Relapsed Multiple Myeloma
  • Refractory Multiple Myeloma
  • Bendamustine
  • Bortezomib
  • Lenalidomide
  • Dexamethasone
  • Treanda
  • Velcade
  • Revlimid
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Loyola Univ Med Cntr - Cardinal Bernardin Cancer CenterMaywood, Illinois  60153