Multiple Myeloma and Plasma Cell NeoplasmPhase 2NCT00022607
Bevacizumab With or Without Thalidomide in Treating Patients With Relapsed or Refractory Multiple Myeloma
A Phase 2 study testing bevacizumab and thalidomide in people with Multiple Myeloma and Plasma Cell Neoplasm, run by California Cancer Consortium at 4 sites in United States.
Trial summary
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma and Plasma Cell Neoplasm
- What is being tested?
- bevacizumab and thalidomide
- How many people
- Not given
- Where
- 4 sitesUnited States
- Study dates
- Jan 2002to May 2006
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed progressing multiple myeloma
- Stages I, II, or III
- More than 25% increase in urine or plasma paraprotein levels
- More than 5% malignant plasma cell involvement in bone marrow
- Smoldering myeloma is eligible provided there is evidence of progressive disease requiring therapy
- At least 25% increase in M protein levels or Bence Jones excretion
- Hemoglobin no greater than 10.5 g/dL
- Frequent infections
- Hypercalcemia
- Rise in serum creatinine above normal on 2 separate occasions
- Nonsecretory multiple myeloma that is bidimensionally measurable by MRI or CT scan is eligible provided the disease site is new or has shown an increase in M protein levels or Bence Jones excretion is greater than 30% from baseline
- No prior or concurrent CNS involvement with primary or metastatic tumor
- No nonquantifiable monoclonal proteins or IgM peaks unless there is evidence of bidimensionally measurable disease by MRI or CT scan
- No history of hemorrhagic tumor or hemorrhagic metastasis
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 70-100%
Life expectancy:
- At least 3 months
Hematopoietic:
- See Disease Characteristics
- Absolute neutrophil count ≥1,000/mm^3
- Platelet count ≥ 50,000/mm^3
- No hemorrhagic illness within the past 3 weeks
Hepatic:
- Bilirubin ≤ 1.5 mg/dL
- SGOT/SGPT≤ 2.5 times upper limit of normal (ULN)
- INR ≤ 1.5
- aPTT < 1.5 times ULN
Renal:
- See Disease Characteristics
- Creatinine ≤ 2 mg/dL
- Creatinine clearance ≥ 40 mL/min
- Calcium ≤ 12 mg/dL
- No nephrotic syndrome
Cardiovascular:
- No active coronary artery disease
- No New York Heart Association class II-IV congestive heart failure
- No grade II or greater peripheral vascular disease (i.e, ischemic rest pain, non-healing ulcer, or tissue loss)
- No uncontrolled hypertension
- No history of deep venous thrombosis
- No vascular illness within the past 3 weeks
- No arterial thromboembolic event within the past 6 months, including any of the following:
- Transient ischemic attack
- Cerebrovascular accident
- Unstable angina
- Myocardial infarction
Pulmonary:
- No history of pulmonary embolus
Other:
- No other prior malignancy unless the patient has been in complete remission for at least 2 years
- No peripheral neuropathy or CNS abnormalities ≥ grade 2
- Patients with prior exposure to thalidomide and assigned to arm I may have grade 2 peripheral or CNS abnormalities
- No seizure disorder
- No serious non-healing wound, ulcer, or bone fracture
- No trauma within the past 3 weeks
- No significant inflammatory illness within the past 3 weeks
- No known hypersensitivity to Chinese hamster ovary cell products
- No known hypersensitivity to other recombinant human or humanized antibodies and/or positive human antimurine antibodies/human antichimeric antibodies
- No other significant medical, psychological, or social problem that would preclude study participation
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception for at least 2 weeks before and during study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Chemotherapy
- Prior nonmyeloablative transplantation allowed provided the following are true:
- Patient is not receiving concurrent immunosuppressive therapy
- Patient has no signs of graft-versus-host disease
- Concurrent epoetin alfa allowed if started at least 4 weeks prior to study entry
Chemotherapy:
- No more than 5 prior chemotherapy regimens
- Thalidomide, steroids, and interferon are not considered part of prior regimens
- Mobilization with chemotherapy followed by either single or tandem autologous transplantation is counted as 1 prior regimen
- Mobilization with chemotherapy followed by autologous and subsequent nonmyeloablative HLA-matched sibling allogeneic transplantation is counted as 1 prior regimen
- At least 3 weeks since prior chemotherapy
- No concurrent chemotherapy
Endocrine therapy:
- See Chemotherapy
- At least 2 weeks since prior steroids
- No concurrent steroids
Radiotherapy:
- At least 3 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery:
- At least 3 weeks since prior surgery, including biopsy of a visceral organ
Other:
- At least 10 days since prior anticoagulants, including aspirin
- At least 2 days since prior nonsteroidal anti-inflammatory agents
- Concurrent bisphosphonates allowed
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90089
University of California Davis Cancer Center
Sacramento, California, 95817
About this study
Official title: Phase II Randomized Trial of Bevacizumab Versus Bevacizumab and Thalidomide for Relapsed/Refractory Multiple Myeloma
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor. It is not yet known whether bevacizumab works better with or without thalidomide for multiple myeloma.
PURPOSE: This randomized phase II trial is to see if bevacizumab works better with or without thalidomide in treating patients who have relapsed or refractory multiple myeloma.
Read the detailed description
OBJECTIVES:
- Compare the response rate and time to progression in patients with relapsed or refractory multiple myeloma treated with bevacizumab with or without thalidomide.
- Compare the toxicity of these regimens in these patients.
- Compare the effects of these regimens on histological and molecular biomarkers of angiogenesis, tumor invasion, and cell death in these patients.
- Correlate plasma and urine vascular endothelial growth factor and basic fibroblast growth factor levels and other potential markers of angiogenesis and myeloma cell proliferation with outcome in patients treated with these regimens.
- Determine the pharmacokinetics of thalidomide in these patients.
- Compare the effects of these regimens on the psychological/physical well being of these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior treatment with thalidomide (yes vs no).
Patients who have received no prior treatment with thalidomide are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, 29, and 43. Patients also receive oral thalidomide once daily.
- Arm II: Patients receive bevacizumab as in arm I. Patients who have received prior treatment with thalidomide receive bevacizumab as in arm I.
Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly for 3 months and then every 3-4 months for 3 years.
PROJECTED ACCRUAL: A total of 55-103 patients (16-32 who have received prior thalidomide, 16-32 in arm I, and 23-39 in arm II) will be accrued for this study within 2.5 years.
- Being tested
- bevacizumab, thalidomide
- Keywords
- refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabBiological
thalidomideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJan 2002
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma and Plasma Cell NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
Sponsor and investigators
- Lead sponsor
- California Cancer Consortium
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00022607
- Sponsor's protocol ID
- CDR0000068834
- Other IDs
- CCC-PHII-30, CHNMC-PHII-30, CHNMC-IRB-01006, NCI-2712
- Status last verified
- Oct 2004
- First submitted
- 10 Aug 2001
- Last updated
- 24 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Trial of Bevacizumab Versus Bevacizumab and Thalidomide for Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00022607
- Acronym / sponsor ID
- CDR0000068834
- Keywords
- refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- California Cancer ConsortiumResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2002
- Study completion
- May 2006 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor. It is not yet known whether bevacizumab works better with or without thalidomide for multiple myeloma.
PURPOSE: This randomized phase II trial is to see if bevacizumab works better with or without thalidomide in treating patients who have relapsed or refractory multiple myeloma.
Detailed description
OBJECTIVES:
- Compare the response rate and time to progression in patients with relapsed or refractory multiple myeloma treated with bevacizumab with or without thalidomide.
- Compare the toxicity of these regimens in these patients.
- Compare the effects of these regimens on histological and molecular biomarkers of angiogenesis, tumor invasion, and cell death in these patients.
- Correlate plasma and urine vascular endothelial growth factor and basic fibroblast growth factor levels and other potential markers of angiogenesis and myeloma cell proliferation with outcome in patients treated with these regimens.
- Determine the pharmacokinetics of thalidomide in these patients.
- Compare the effects of these regimens on the psychological/physical well being of these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior treatment with thalidomide (yes vs no).
Patients who have received no prior treatment with thalidomide are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, 29, and 43. Patients also receive oral thalidomide once daily.
- Arm II: Patients receive bevacizumab as in arm I. Patients who have received prior treatment with thalidomide receive bevacizumab as in arm I.
Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly for 3 months and then every 3-4 months for 3 years.
PROJECTED ACCRUAL: A total of 55-103 patients (16-32 who have received prior thalidomide, 16-32 in arm I, and 23-39 in arm II) will be accrued for this study within 2.5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bevacizumab | Biological | – |
| thalidomide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bevacizumab and thalidomide in people with Multiple Myeloma and Plasma Cell Neoplasm, run by California Cancer Consortium at 4 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?
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 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
Where can I read the original study information?
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 24 Jun 2013.