Subcutaneous (SC) Bortezomib-Regimens for Patients With RR MM Failing Prior IV Bortezomib-Containing Regimens

Stopped early · Phase 2

Conditions studied: Multiple Myeloma

In brief

This is a phase 2, multicenter, open label, nonrandomized study for patients with MM who will receive treatment with a SC bortezomib-containing combination regimen that does not contain thalidomide or vincristine. The patients will be required to have received a prior IV bortezomib containing combination regimen that did not contain thalidomide or vincristine and that differs from the SC bortezomib-containing one. In between the time that the patient received the IV bortezomib-based combination regimen and enrollment onto this study, patients may have received other non-bortezomib-based regimens as long as these treatments did not contain thalidomide or vincristine. This study will enroll patients who have relapsed or have become refractory to their prior IV-administered bortezomib-containing combination regimen as demonstrated by progressive disease while on or following that regimen. Patients must have received 4 doses of a minimum of 1.0 mg/m2 of bortezomib administered IV in no more than 4 weeks per cycle. Patients must have received at least one cycle meeting this definition and have shown progressive disease to be considered eligible. Patients who have relapsed or have become refractory to their most recent IV bortezomib-containing combination regimen are eligible regardless of when they received that regimen, as long as they meet the above criteria. The study will consist of a screening period, followed by up to eight open label treatment cycles, a final assessment to occur 28 days after the end of the last treatment cycle, and a follow-up period.

Key facts

Study ID

NCT01695330

Run by

Oncotherapeutics

People needed

5

Starts

2012-05-01

Expected to finish

2015-10-01

Last updated by the study team

2017-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• POEMS syndrome
• PCL
• Primary amyloidosis
• Diagnosed or treated for another malignancy w/in 3 yrs of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
• ≤ Grade 2 peripheral neuropathy
• Pt had myocardial infarction w/in 6 months prior to enrollment or has NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
• Severe hypercalcemia, i.e., serum calcium ≤ 12 mg/dL (3.0 mmol/L) corrected for albumin
• Undergone major surgery w/in 28 days prior enrollment or has not recovered from side effects of such therapy (see protocol)
• Received the following prior therapy:
• Thalidomide or vincristine alone or as part of a treatment regimen administered between the last IV bort.-based regimen and Cycle 1, Day 1 on this study. However, prior exposure to thalidomide or vincristine is allowed.
• Chemotherapy w/in 21 days of study drugs (6 weeks for nitrosoureas)
• Corticosteroids (>10 mg/day prednisone or equivalent) w/in 21 days of study drugs unless steroids are being administered at that dose or greater as part of the new regimen
• Immunotherapy or antibody therapy as well as lenalidomide, arsenic trioxide or bort. w/in 21 days before study drugs
• Radiation therapy w/in 21 days before study drugs. (see protocol for exceptions)
• Use of any other experimental drug or therapy w/in 28 days of study drugs
• Participation in clinical trials with other investigational agents not included in this trial, w/in 14 days of the start of this trial and throughout the duration of this trial.
• Hypersensitivity to VELCADE (bort.), boron, or mannitol.
• Concurrent use of other anti-cancer agents or treatments
• Pregnant or lactating patients
• Serious medical or psychiatric illness
• Known positivity for HIV or hepatitis B or C

Where it is running

• James R. berenson, M.D., Inc. — West Hollywood, California, United States

Full record on ClinicalTrials.gov

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