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A Phase 1/2, Two-Arm, Dose-Finding Study of Natalizumab for the Treatment of Subjects With Relapsed or Refractory Multiple Myeloma.


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

A Phase 1/2, Two-Arm, Dose-Finding Study of Natalizumab for the Treatment of Subjects With Relapsed or Refractory Multiple Myeloma.


Inclusion Criteria:



- Age >/=18 years at the time of informed consent

- Relapsed or refractory multiple myeloma that was treated with or was considered
inappropriate for treatment with bortezomib and an IMiD drug (including an analogue).

- ECOG Performance Status
- Corrected calcium <10.6 mg/dL

Exclusion Criteria:

- Candidates for stem cell transplantation willing to undergo transplantation.
(Subjects who are candidates for stem cell transplantation, but are not willing to
undergo transplant will be eligible for the study.)

- Autologous stem cell transplantation <3 months post transplant.

- Prior allogeneic stem cell transplantation.

- Non secretory myeloma.

- Plasma cell leukemia (>2000/uL circulating plasma cells by standard cell counting
differential), hyperleukocytosis (white blood cells >100,000/uL, clinical evidence of
hyperviscosity syndrome, POEMS (polyneuropathy, organomegaly, endocrinopathy,
monoclonal gammopathy, and skin changes syndrome), or primary systemic amyloidosis.

- Subjects who cannot undergo a brain MRI study.

- Clinically significant (as determined by the Investigator) 12 lead electrocardiogram
(ECG) abnormalities, including QTc prolongation (>450 ms in males; >470 ms in
females).

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To evaluate the safety profile of 2 dose levels of natalizumab in subjects with relapsed or refractory multiple myeloma

Outcome Time Frame:

ongoing

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

101MY201

NCT ID:

NCT00675428

Start Date:

May 2008

Completion Date:

December 2010

Related Keywords:

  • Multiple Myeloma
  • Relapsed or refractory Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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