NCT00483262 · REGISTRY CONDITION SEARCH

Combination CCI-779 (Temsirolimus) and Bortezomib (Velcade) in Relapsed and/or Relapsed/Refractory Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1, PHASE2
Status at capture: COMPLETED
Registry last update: 2013-11-11

The purpose of this research study is to determine the safety of CCI-779 (Temsirolimus) and bortezomib (Velcade), and the highest dose of this drug that can be given to people safely. We will also be looking at how the combination of the two drugs may work against multiple myeloma. CCI-779 (Temsirolimus) is a drug that appears to stop myeloma cells from growing.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Toxicity. Number of Patients With Specific Toxicities Are Reported.

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outcome · POSTED

Best Response to Combination Treatment

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outcome · POSTED

Progression-Free Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * 18 years of age or older * Must have received prior therapy for their myeloma and have relapsed and/or relapsed/refractory multiple myeloma * Monoclonal protein in the serum of greater than or equal to 1 gm/dL or monoclonal light chain in the urine protein electrophoresis of greater than or equal to 200mg/24 hours, or measurable light chains by free light chain assay of greater than or equal to 10mg/dl, or measurable plasmacytoma * ECOG Performance Status 0, 1 or 2 * Laboratory values as outlined in the protocol Exclusion Criteria: * Uncontrolled infection * Cytotoxic chemotherapy less than 2 weeks, or biologic therapy less than 2 weeks, or corticosteroids less than 2 weeks prior to registration. Patients may be receiving chronic corticosteroids if they are being given for disorders other than myeloma. * Pregnant or nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception * Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational within 14 days before enrollment * Known to be HIV positive * Myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV hear failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities * Hypersensitivity to bortezomib, boron or mannitol * Serious medical or psychiatric illness likely to interfere with participation in this clinical trial * Patients who may need or are receiving live vaccines for immunization
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
In Phase I part, 15 or 25 mg temsirolimus (CCI-779)and 1·3 or 1·6 mg/m² bortezomib was given once a week.In Phase II, patients received intravenous temsirolimus once a week on days 1, 8, 15, 22, and 29 for a cycle of 35 days, and intravenous bortezomib once a week on days 1, 8, 15, and 22 for a cycle of 35 days, the MTD ascertained in the Phase I part.
intervention Names
Drug: CCI-779
Drug: Bortezomib
label
CCI779 and Bortezomib Phase I/II
type
EXPERIMENTAL

interventions

arm Group Labels
CCI779 and Bortezomib Phase I/II
description
Given by injection once a week for 5 weeks (5 weeks equals one cycle) for up to 8 cycles
name
CCI-779
other Names
Temsirolimus
type
DRUG
arm Group Labels
CCI779 and Bortezomib Phase I/II
description
Given by injection once a week for 4 weeks (a cycle equals 5 weeks) for up to 8 cycles
name
Bortezomib
other Names
Velcade
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 63
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Toxicity of CCI-779 (Temsirolimus) and bortezomib (Velcade) in patients with multiple myeloma.
measure
Toxicity. Number of Patients With Specific Toxicities Are Reported.
time Frame
10 months
description
Response rate of PR or better to the combination treatment of CCI-779 (Temsirolimus) and bortezomib (Velcade) in patients with relapsed or refractory multiple myeloma
measure
Best Response to Combination Treatment
time Frame
10 months

secondary Outcomes

description
Median time to progression or death
measure
Progression-Free Survival
time Frame
10 months

Full study description

brief Summary: The purpose of this research study is to determine the safety of CCI-779 (Temsirolimus) and bortezomib (Velcade), and the highest dose of this drug that can be given to people safely. We will also be looking at how the combination of the two drugs may work against multiple myeloma. CCI-779 (Temsirolimus) is a drug that appears to stop myeloma cells from growing.
detailed Description: * Since we are looking for the highest dose of CCI-779 (Temsirolimus) given in combination with bortezomib (Velcade) that can be given to people without causing the most serious or unmanageable side effects, not everyone who participates in this study will be receiving the same amount of either drug. * During the study treatment, participants will be given some medications to decrease the chance they they will have an allergic reaction to CCI-779 (Temsirolimus). After these drugs are given, participants will be receive bortezomib (Velcade) by injection followed by an injection of CCI-779 (Temsirolimus). These drugs wil be given once a week for four weeks (on Days 1, 8, 15, and 22). On the fifth week (Day 29), participants will be given only CCI-779 along with the drugs to decrease the chance of an allergic reaction. * The cycle will last 35 days and will occur twice before the doctor evaluates for response. The cycles will be repeated for up to 8 cycles as long as the participant does not have any severe or unmanageable side effects and the disease is responding to treatment. * While receiving study treatment, participants will be seen at the clinic at the start of each cycle for the following: complete physical examination, blood work, urine collection, x-ray of bones (if study doctor deems necessary) and an electrocardiogram (prior to treatment and at the end of treatment) * A bone skeletal survey will be performed at the end of treatment to measure the size of the participants tumors. * After 8 cycles of treatment or if the participant has ended treatment, more tests will be performed. A physical exam, blood work, urine collection, skeletal survey, electrocardiogram, bone marrow biopsy and aspirate will be performed.

Source references

references

citation
Ghobrial IM, Weller E, Vij R, Munshi NC, Banwait R, Bagshaw M, Schlossman R, Leduc R, Chuma S, Kunsman J, Laubach J, Jakubowiak AJ, Maiso P, Roccaro A, Armand P, Dollard A, Warren D, Harris B, Poon T, Sam A, Rodig S, Anderson KC, Richardson PG. Weekly bortezomib in combination with temsirolimus in relapsed or relapsed and refractory multiple myeloma: a multicentre, phase 1/2, open-label, dose-escalation study. Lancet Oncol. 2011 Mar;12(3):263-72. doi: 10.1016/S1470-2045(11)70028-6. Epub 2011 Feb 21.
pmid
21345726
type
RESULT

Source notices and limitations

Discovery and provenance

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query disease state id
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source string sha256
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source url
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Preserved source evidence · Not medical advice