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Phase II Study of Subcutaneous (SC) Bortezomib, Lenalidomide and Dexamethasone for Relapsed and/or Refractory Multiple Myeloma; Followed by SC Bortezomib Maintenance

NCT01647165 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-12-12

No results posted yet for this study

Summary

Background: Bortezomib is a drug approved by the Food and Drug Administration (FDA) to treat patients with multiple myeloma. It is given by intravenous injection. Lenalidomide is a drug that alters the immune system. It may also help suppress tumor growth. It is approved by the FDA to treat some types of blood cancers. Dexamethasone prevents or treats inflammation. It is sometimes used to treat multiple myeloma.

Objectives: The purpose of this study examine how the combination of the study drugs affects myeloma.

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Eligibility:

* Participants at least 18 years old who have multiple myeloma that has come back, did not respond to treatment, or worsened while being treated.
* Participants who may be pregnant will be tested to ensure that they are not pregnant.

Design:

* Participants will be screened with a history and physical examination. Blood work and urine samples will be taken. A series of x-rays of all bones will be done. A bone marrow biopsy will be done.
* Treatment will be monitored with frequent blood tests and imaging studies.
* Treatment will continue as long as the cancer does not grow or spread and no serious side effects develop.
* There will be up to eight 21-day treatment cycles.
* Bortezomib is given by subcutaneous (under the skin) (SC) injection on days 1, 4, 8, and 11 of the cycle.
* Lenalidomide is given by mouth on days 1 14 of the cycle.
* Dexamethasone is given by mouth on days 1, 2, 4, 5, 8, 9, 11, and 12 of the cycle.
* Following cycle eight, if the disease is stable or better, participants will receive bortezomib SC at the dose given at the end of cycle eight.
* Participants will take valacyclovir or acyclovir while taking bortezomib to prevent virus infections.

Conditions

Interventions

DRUG

Bortezomib

Cycle 1-8: 1.0 mg/m2 SC at a concentration of 2.5 mg/ml or 1 mg/ml to the thighs or abdomen on days 1, 4, 8, 11 of a 21 day cycle for 8 cycles.

DRUG

Lenalidomide

Cycle 1: 15 mg oral daily on days 2-14 of 21 day cycle; Cycle 2-8: 15 mg oral daily on days 1-14 of a 21 day cycle

DRUG

Dexamethasone

Cycle 1: 10 mg oral or IV daily on days 2,4,5,8,9,11,12 of a 21 day cycle; Cycle 2-8: 10 mg oral or IV on days 1, 2, 4, 5, 8, 9, 11, 12 of a 21 day cycle

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Carl O Landgren, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-11
Primary Completion
2015-06-26
Completion
2015-06-26

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01647165 on ClinicalTrials.gov