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Refractory Multiple MyelomaPhase 2NCT00079456

Temsirolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma

A Phase 2 study testing temsirolimus, pharmacological study and laboratory biomarker analysis in people with Refractory Multiple Myeloma and Stage I Multiple Myeloma, run by National Cancer Institute (NCI) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase II trial is studying how well temsirolimus works in treating patients with relapsed or refractory multiple myeloma. Drugs used in chemotherapy such as temsirolimus work in different ways to stop cancer cells from dividing so they stop growing or die. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
temsirolimus, pharmacological study and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
2 sitesUnited States
Study dates
Feb 2004to Feb 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of multiple myeloma (MM)
  • Salmon-Durie stage IIA or IIIA OR progressive stage IA disease
  • Meets at least 1 major AND 1 minor criterion OR at least 3 minor criteria
  • The following are considered major criteria:
  • Plasmacytoma on tissue biopsy
  • Bone marrow plasmacytosis with >= 30% plasma cells
Show all 47Show fewer
  • Monoclonal globulin spike on serum protein electrophoresis exceeding 3.5 g/dL for immunoglobulin (Ig) G peaks or 2.0 g/dL for IgA peaks OR the presence of Bence-Jones protein of >= 1 g/24 hour-urine collection
  • The following are considered minor criteria:
  • Bone marrow plasmacytosis 10-29%
  • Monoclonal globulin spike present, but less than the levels defined for a major criterion
  • Lytic bone lesion
  • Decrease in normal IgM < 50 mg/dL, IgA < 100 mg/dL, or IgG < 600 mg/dL
  • No non-secretory MM (absent serum or urinary M-protein)
  • Failed at least 1 prior systemic therapy* (e.g., chemotherapy, high-dose corticosteroids, thalidomide, or bortezomib) for the treatment of MM
  • No solitary plasmacytoma
  • Performance status - ECOG 0-2
  • More than 6 months
  • Absolute neutrophil count > 1,200/mm^3
  • Platelet count > 75,000/mm^3
  • AST and ALT =< 2.5 times upper limit of normal (ULN)
  • Bilirubin =< 1.5 times ULN
  • Creatinine =< 1.5 times ULN
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Fasting cholesterol =< 350 mg/dL
  • Triglycerides =< 400 mg/dL
  • No other concurrent uncontrolled illness
  • No active or ongoing infection requiring oral or IV antibiotics
  • No prior allergic reaction to compounds of similar chemical or biological composition to CCI-779
  • No other prior or concurrent malignancy or myelodysplasia except for the following:
  • Basal cell or squamous cell skin cancer
  • Carcinoma in situ of the cervix
  • Localized cancer treated with surgery only with no evidence of disease for > 5 years
  • No psychiatric illness or social situation that would preclude study compliance
  • More than 4 weeks since prior thalidomide and recovered
  • Prior high-dose chemotherapy and stem cell transplantation allowed
  • More than 4 weeks since prior chemotherapy and recovered
  • More than 4 weeks since prior high-dose corticosteroids and recovered
  • More than 4 weeks since prior bortezomib and recovered
  • More than 4 weeks since other prior anti-myeloma systemic therapy and recovered
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: A Phase II Trial of CCI-779 in Patients With Relapsed or Refractory Multiple Myeloma

This phase II trial is studying how well temsirolimus works in treating patients with relapsed or refractory multiple myeloma. Drugs used in chemotherapy such as temsirolimus work in different ways to stop cancer cells from dividing so they stop growing or die.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the overall response rate in patients with relapsed or refractory multiple myeloma treated with CCI-779.

SECONDARY OBJECTIVES:

  1. Determine the progression-free survival of patients treated with this drug. II. Determine the toxicity of this drug in these patients. III. Determine the presence of PTEN mutation in patients treated with this drug.

IV. Correlate the pharmacokinetics of this drug with response in these patients.

  1. Correlate the pharmacodynamic effects of this drug with response in these patients.

OUTLINE: This is an open-label study.

Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Being tested
temsirolimus, pharmacological study, laboratory biomarker analysis
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • temsirolimusDrug

    Also called CCI-779, cell cycle inhibitor 779, Torisel

    Given IV

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00079456
Study groupRoleWhat they receive
Treatment (temsirolimus)ExperimentalPatients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: temsirolimus; Other: pharmacological study; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with objective overall response rate (PR+CR)

    Measured: Up to 5 years

Secondary outcomes (2)

  1. Progression-free survival

    Measured: Time from the initial administration of temsirolimus to first documentation of disease progression or death, assessed up to 5 years

  2. Incidence of toxicities

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2004 (estimated)
  2. Study startFeb 2004
  3. Primary completionFeb 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00079456
Sponsor's protocol ID
NCI-2012-01448
Other IDs
NCI-2012-01448, NCI-6186, OSU-0347, CDR0000355767, OSU-2003C0090, 0347, 6186, R21CA112894
Status last verified
Oct 2013
First submitted
8 Mar 2004
Last updated
11 Oct 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing temsirolimus, pharmacological study and laboratory biomarker analysis in people with Refractory Multiple Myeloma and Stage I Multiple Myeloma, run by National Cancer Institute (NCI) at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 47 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with objective overall response rate (PR+CR) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00079456.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2013.

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