CompletedNCT00153933Updated Jan 25, 2016

Bortezomib in Combination With CC-5013 in Patients With Relapsed/Refractory Multiple Myeloma

A Phase 1 interventional study of Bortezomib and CC-5013 in Refractory Multiple Myeloma, Relapsed Multiple Myeloma and Multiple Myeloma, sponsored by Dana-Farber Cancer Institute. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-01-25.

Sponsored by Dana-Farber Cancer Institute · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 58
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

The purpose if this study is to evaluate the side effects of the combination of bortezomib and Revlimid (CC-5013) in patients with relapsed and relapsed/refractory multiple myeloma.

Read the detailed description

Within 21 days of starting treatment the following tests will be performed: physical exam (including vital signs), ECG, neurological examination, blood tests, urine tests, bone marrow aspiration, x-rays and MRI or CT scan.
Patients will receive bortezomib intravenously on day 1,4,8 and 11 followed by 10 days of rest. CC-5013 will be given orally on days 1-14 followed by 7-dyas of rest. One cycle lasts 21 days. This study will evaluate different dose levels of bortezomib and CC-5013 to see which dose level seems to be the best for most people. There will be 8 dose levels.
Patients will be assigned to a dose level depending upon when they begin the study and how other dose levels have been tolerated by patients that are already on the study. Three to six patients will be treated at each dose level and will be observed for one full cycle. Depending upon the side effects, the dose level will increase, stay the same or be decreased by one level for the next group. 10 additional patients will be treated at the dose that is thought the best.
On day four of the treatment cycle blood tests, vital signs and a review of side effects will be performed.
On day eight of the the treatment cycle blood tests, vital signs, review of side effects and an ECG will be performed prior to medication administration. A bortezomib level will be taken before bortezomib infusion, 15 minutes, 1/2 hour, 45 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours and 12 hours after the dose. Additional blood levels will be collected 24, 48, and 72 hours after the dose. (These blood levels will done during the first cycle only).
On day 11 and day 14 of the treatment cycle blood tests, vital signs and review of side effects will be performed.
After 2 cycles of treatment, the doctor will assess how the patient's disease is responding to the treatment. Additional tests such as bone marrow biopsy, x-rays or scans may be performed. If the disease is stable or getting better, patients will continue to receive repeated cycles of treatment. If the disease is getting worse, dexamethasone may be added to the treatment cycle.
If dexamethasone is added, the dosing will start on days 1,2,4,5,8,9 and 11 of the 21-day cycle. The disease will then be reassessed after 2 additional cycles. If the disease is getting worse, the patient will be removed from the study.
Once 8 cycles of treatment have been performed, the disease will be fully assessed again by blood tests, bone marrow biopsy, x-rays or scans. Again, if it is determined that the disease is stable of getting better, additional treatment cycles can be performed. If the disease is getting worse, treatment will be stopped..
A follow-up visit will be scheduled one month after the last dose of the study drug and will include: physical exam, vital signs, neurological examination, and review of symptoms.
Patients will remain on this study as long as the side effects are not too severe and the disease has not progressed.

Conditions studied

Refractory Multiple Myeloma
Relapsed Multiple Myeloma
Multiple Myeloma

Browse trials for

Multiple Myeloma 3,712

Keywords

Multiple Myeloma
bortezomib
Revlimid
CC-5013

In context

Multiple Myeloma

3,712 studies on the registry are indexed under Multiple Myeloma; 752 are open to participants now.

This study's enrollment of 58 is above the median of 41 across 2,965 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Dana-Farber Cancer Institute is the lead sponsor of 832 studies on the registry; 122 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Diagnosis of multiple myeloma based on standard diagnosis criteria: plasmacytomas on tissue biopsy; bone marrow plasmacytosis; monoclonal immunoglobulin spike on serum electrophoresis; lytic bone lesions.
Must have relapsed or relapsed/refractory disease
18 years of age or older
All baseline studies must be performed within 21 days of enrollment.
ECOG performance status of 0 to 2

Exclusion criteria

Exclusion Criteria:

Renal insufficiency (serum creatinine levels > 2mg/dL)
Concomitant therapy medications that include corticosteroids
Peripheral neuropathy of Grade 3 or greater or painful Grade 2
Evidence of mucosal or internal bleeding and/or platelet refractory
ANC \< 1000 cells/mm3
Hemoglobin \< 8.0 g/dL
AST (SGOT and ALT) > 2 x ULN
Intolerance to bortezomib or CC-5013 in the past or significant allergy to either compound, boron or mannitol
Known hypersensitivity to thalidomide or the development of erythema nodosum
Active infection or serious co-morbid medical condition
Pregnant or breast-feeding women
Prior malignancy with the last three years except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, on in-situ prostate cancer

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 58 participants (actual)

Study arms

Experimental
CC-5013 in combination with bortezomib
Participants will receive bortezomib intravenously on day 1,4,8 and 11 followed by 10 days of rest. CC-5013 will be given orally on days 1-14 followed by 7-days of rest. One cycle lasts 21 days.
Drug: Bortezomib · Drug: CC-5013

Interventions

DrugBortezomib
Given intravenously on days 1, 2, 8, 11 of each 21-day cycle. Participants can remain on study treatment as long as their disease doesn't worsen and they don't experience any serious side effects.
Also known as: velcade
DrugCC-5013
Orally on days 1-14 of each 21-day cycle. Participants can remain on study treatment as long as their disease doesn't worsen and they don't experience any serious side effects.
Also known as: Revlimid, Lenalidomide

What researchers measure

Primary outcomes

To evaluate the safety of bortezomib when given in combination with CC-5013 in subjects with relapsed and relapsed/refractory multiple myeloma, to identify the MTD as well as a RP2D.
Time frame: 2 years

Secondary outcomes

To evaluate the response of the combination of bortezomib and CC-5013
To determine the pharmacokinetics of bortezomib and CC5013 in patients with multiple myeloma.
Time frame: 2 years

Study locations

6 sites

H. Lee Moffitt Cancer Center
Tampa, Florida 33612, United States
Winship Cancer Center
Atlanta, Georgia 30322, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02115, United States
Dana-Farber Cancer Center
Boston, Massachusetts 02115, United States
University of Michigan
Ann Arbor, Michigan 48109, United States
St. Vincent's Comprehensive Cancer Center
New York, New York 10011, United States

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2004, a primary completion of Jul 2014 and a completion of Jul 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Sep 8, 2005
First posted: Sep 12, 2005
Start: Aug 2004
Primary completionActual: Jul 2014
CompletionActual: Jul 2014
Last update: Jan 25, 2016

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jan 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00153933
Lead sponsor: Dana-Farber Cancer Institute
Collaborators: Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, H. Lee Moffitt Cancer Center and Research Institute
Responsible party: Paul G. Richardson, MD (Principle Investigator, Dana-Farber Cancer Institute) — Principal investigator
First posted: Sep 12, 2005
Start date: Aug 2004
Primary completion: Jul 2014
Completion: Jul 2014
Last update: Jan 25, 2016

Study contacts

Paul Richardson, MD

principal investigator · Dana-Farber Cancer Institute

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Bortezomib · Lenalidomide

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