Waldenstrom's MacroglobulinemiaPhase 2NCT00142168
CC-5013 (Lenalidomide) and Rituximab in Waldenstrom's Macroglobulinemia
A Phase 2 study testing CC-5103 (lenalidomide) and Rituximab in people with Waldenstrom's Macroglobulinemia, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
The purpose of this study is to determine the number of patients with Waldenstrom's macroglobulinemia that will benefit from treatment with CC-5103 (lenalidomide) and rituximab, what the side effects are and how long the benefit will last. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Waldenstrom's Macroglobulinemia
- What is being tested?
- CC-5103 (lenalidomide) and Rituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2004to Apr 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinicopathological diagnosis of Waldenstrom's macroglobulinemia using consensus panel criteria
- Age 18 years or older
- CD20 positive based on any previous bone marrow immunohistochemistry or flow cytometric analysis
- All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study
- Measurable disease, defined as presence of immunoglobulin M paraprotein with a minimum IgM level of equal to or greater than 2 times the upper limit of normal.
- ECOG performance status of 0-2
Show all 13Show fewer
- Absolute neutrophil count ≥ 100,000,000/L
- Platelet count ≥ 50,000,000,000/L
- Hemoglobin > 8 g/dL
- Serum creatinine < 2.5 mg/dL
- Total bilirubin < 1.5 mg/dL
- AST and ALT < 2.5 x ULN
- Disease free of prior malignancies fir 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast
Who cannot join
- Any serious medical condition, laboratory abnormality, or psychiatric illness
- Pregnant or lactating women
- Prior therapy with rituximab or CC-5103
- Known hypersensitivity to thalidomide
- Development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- Concurrent use of other anti-cancer agents or treatments
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Phase II Study of CC-5103 and Rituximab in Waldenstrom's Macroglobulinemia
The purpose of this study is to determine the number of patients with Waldenstrom's macroglobulinemia that will benefit from treatment with CC-5103 (lenalidomide) and rituximab, what the side effects are and how long the benefit will last.
Read the detailed description
- The study drug CC-5103 (lenalidomide) will be administered orally once daily for 21 days followed by 7 days of no CC-5103 (lenalidomide) (this will be one 28 day treatment cycle). This cycle will repeat itself every 28 days as long as the patient is tolerating the medication and there is no disease progression.
- Starting on the second week, patients will begin treatment with rituximab intravenously once a week for 4 weeks (week 2-5). Prior to each treatment, patients will receive medications to prevent or reduce the side effects of rituximab (benadryl, tylenol and possible decadron). During the infusion, the patients' blood pressure and pulse will be monitored frequently and the rate of infusion may decrease depending upon the side effects. Blood work will also be performed each week.
- On week 12 the disease status will be evaluated. A physical exam, blood test, CT scan and bone marrow biopsy may be repeated if necessary to fully evaluate the disease. If the disease has gone away completely, some tests may be repeated again to confirm this.
- If the disease has gotten worse after 12 weeks, then the patient will be removed from the study.
- If the disease is stable or getting better, the patient will continue with therapy. During weeks 13-16 rituximab infusions will be repeated and CC-5103 will continue to be taken daily for 21 days followed by 7 days of rest. This 28 day cycle may be repeated until the patient has completed 48 weeks (12 months) of treatment as long as the side effects are acceptable and the disease does not progress.
- All patients will undergo an off-study evaluation that includes a physical exam, blood work, CT scans and bone marrow biopsy. If the patient completes 78 weeks of therapy and the disease does not get worse, they will be evaluated every 12 weeks to determine the status of their disease for up to 2 years.
- Conditions
- Waldenstrom's Macroglobulinemia
- Being tested
- CC-5103 (lenalidomide), Rituximab
- Keywords
- CC-5103 (lenalidomide), rituximab, Waldenstrom's macroglobulinemia
- Medical subject headings
- Waldenstrom Macroglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-5103 (lenalidomide)Drug
Also called lenalidomide, Revlimid
Taken orally once a day for 21 days followed by 7 days of no CC-5103 (lenalidomide)
RituximabDrug
Also called Rituxan
Begins on week 2 of treatment and is given intravenously once a week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| CC-5103 (Lenalidomide) and Rituximab | Experimental | Intended therapy consisted of 48 weeks of CC-5103 (lenalidomide)(25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16. Receives: Drug: CC-5103 (lenalidomide); Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Progression
Time to progression is measured as the length in time in months from starting therapy until progression, defined as 25% increase in serum IgM from nadir.
Measured: 34.3 months
Overall Response
Overall response is the total number of participants who respond to therapy. Patients achieving a complete response (CR) will be defined as having achieved resolution of all symptoms, normalization of their serum IgM levels with complete disappearance of their IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly during any point while in this study and normal bone marrow biopsy. Patients achieving a partial response (PR) and a minor response (MR) will be defined as achieving a > 50% and > 25% reduction in serum IgM levels, respectively, during any point while in this study. Patients with stable disease (SD) will be defined as having < 25% change in serum IgM levels, in the absence of new or increasing adenopathy or splenomegaly and/or other progressive signs or symptoms of WMduring any point while in this study.
Measured: 34.3 months
Secondary outcomes (2)
Major Response Rate
Major response rate is the number of participants who achieve at a PR or better. A PR or better will be defined as achieving a >50% reduction in serum IgM levels.
Measured: 34.3 months
Minor Response Rate
A minor response is defined as having achieved >25% but less than 50% reduction in serum IgM levels.
Measured: 34.3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionMay 2006
- Study completionApr 2008
Why it stopped: Toxicity
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Waldenstrom's MacroglobulinemiaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Celgene Corporation, Genentech, Inc.
- Responsible party
- Principal investigator, Steven P. Treon, MD, PhD, Dana-Farber Cancer Institute
- Investigators
- Steven Treon, MD, MA, PhD, Principal investigator, Dana-Farber Cancer Insitute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00142168
- Sponsor's protocol ID
- 04-158
- Status last verified
- Mar 2016
- First submitted
- 1 Sep 2005
- Last updated
- 21 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Treon SP, Soumerai JD, Branagan AR, Hunter ZR, Patterson CJ, Ioakimidis L, Chu L, Musto P, Baron AD, Nunnink JC, Kash JJ, Terjanian TO, Hyman PM, Nawfel EL, Sharon DJ, Munshi NC, Anderson KC. Lenalidomide and rituximab in Waldenstrom's macroglobulinemia. Clin Cancer Res. 2009 Jan 1;15(1):355-60. doi: 10.1158/1078-0432.CCR-08-0862.
PubMed 19118065
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of CC-5103 and Rituximab in Waldenstrom's Macroglobulinemia
- ClinicalTrials.gov ID
- NCT00142168
- Acronym / sponsor ID
- 04-158
- Conditions
- Waldenstrom's Macroglobulinemia
- Keywords
- CC-5103 (lenalidomide), rituximab, Waldenstrom's macroglobulinemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Toxicity
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Celgene Corporation, Genentech, Inc.
- Study start
- Sep 2004
- Primary completion
- May 2006 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 2 Sep 2005 (estimated)
- Results
- Posted 16 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the number of patients with Waldenstrom's macroglobulinemia that will benefit from treatment with CC-5103 (lenalidomide) and rituximab, what the side effects are and how long the benefit will last.
Detailed description
- The study drug CC-5103 (lenalidomide) will be administered orally once daily for 21 days followed by 7 days of no CC-5103 (lenalidomide) (this will be one 28 day treatment cycle). This cycle will repeat itself every 28 days as long as the patient is tolerating the medication and there is no disease progression.
- Starting on the second week, patients will begin treatment with rituximab intravenously once a week for 4 weeks (week 2-5). Prior to each treatment, patients will receive medications to prevent or reduce the side effects of rituximab (benadryl, tylenol and possible decadron). During the infusion, the patients' blood pressure and pulse will be monitored frequently and the rate of infusion may decrease depending upon the side effects. Blood work will also be performed each week.
- On week 12 the disease status will be evaluated. A physical exam, blood test, CT scan and bone marrow biopsy may be repeated if necessary to fully evaluate the disease. If the disease has gone away completely, some tests may be repeated again to confirm this.
- If the disease has gotten worse after 12 weeks, then the patient will be removed from the study.
- If the disease is stable or getting better, the patient will continue with therapy. During weeks 13-16 rituximab infusions will be repeated and CC-5103 will continue to be taken daily for 21 days followed by 7 days of rest. This 28 day cycle may be repeated until the patient has completed 48 weeks (12 months) of treatment as long as the side effects are acceptable and the disease does not progress.
- All patients will undergo an off-study evaluation that includes a physical exam, blood work, CT scans and bone marrow biopsy. If the patient completes 78 weeks of therapy and the disease does not get worse, they will be evaluated every 12 weeks to determine the status of their disease for up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CC-5103 (Lenalidomide) and Rituximab | Experimental | Drug: CC-5103 (lenalidomide), Drug: RituximabIntended therapy consisted of 48 weeks of CC-5103 (lenalidomide)(25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Clinicopathological diagnosis of Waldenstrom's macroglobulinemia using consensus panel criteria
- Age 18 years or older
- CD20 positive based on any previous bone marrow immunohistochemistry or flow cytometric analysis
- All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study
- Measurable disease, defined as presence of immunoglobulin M paraprotein with a minimum IgM level of equal to or greater than 2 times the upper limit of normal.
Key exclusion criteria (6 listed)
- Any serious medical condition, laboratory abnormality, or psychiatric illness
- Pregnant or lactating women
- Prior therapy with rituximab or CC-5103
- Known hypersensitivity to thalidomide
- Development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
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 |
|---|---|---|
| CC-5103 (lenalidomide)Also: lenalidomide, RevlimidTaken orally once a day for 21 days followed by 7 days of no CC-5103 (lenalidomide) | Drug | CC-5103 (Lenalidomide) and Rituximab |
| RituximabAlso: RituxanBegins on week 2 of treatment and is given intravenously once a week for 4 weeks | Drug | CC-5103 (Lenalidomide) and Rituximab |
Primary outcome
Time to Progression
Time frame: 34.3 months
Time to progression is measured as the length in time in months from starting therapy until progression, defined as 25% increase in serum IgM from nadir.
Overall Response
Time frame: 34.3 months
Overall response is the total number of participants who respond to therapy. Patients achieving a complete response (CR) will be defined as having achieved resolution of all symptoms, normalization of their serum IgM levels with complete disappearance of their IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly during any point while in this study and normal bone marrow biopsy. Patients achieving a partial response (PR) and a minor response (MR) will be defined as achieving a > 50% and > 25% reduction in serum IgM levels, respectively, during any point while in this study. Patients with stable disease (SD) will be defined as having < 25% change in serum IgM levels, in the absence of new or increasing adenopathy or splenomegaly and/or other progressive signs or symptoms of WMduring any point while in this study.
2 secondary outcomes
Major Response Rate
Time frame: 34.3 months
Minor Response Rate
Time frame: 34.3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19118065Treon SP, Soumerai JD, Branagan AR, Hunter ZR, Patterson CJ, Ioakimidis L, Chu L, Musto P, Baron AD, Nunnink JC, Kash JJ, Terjanian TO, Hyman PM, Nawfel EL, Sharon DJ, Munshi NC, Anderson KC. Lenalidomide and rituximab in Waldenstrom's macroglobulinemia. Clin Cancer Res. 2009 Jan 1;15(1):355-60. doi: 10.1158/1078-0432.CCR-08-0862.
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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.
Steven Treon, MD, MA, PhD principal investigator
Dana-Farber Cancer Insitute
2 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 CC-5103 (lenalidomide) and Rituximab in people with Waldenstrom's Macroglobulinemia, run by Dana-Farber Cancer Institute 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 13 inclusion and 6 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: stopped early, as of the sponsor's last update on 21 Apr 2016. 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?
Yes. Results are posted in the registry (first posted 16 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time to Progression (time frame: 34.3 months). The study lists 2 primary outcomes in all. 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 NCT00142168, which also lists 1 linked publication.
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 21 Apr 2016.