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MyelodysplasiaPhase 1NCT00580242

A Phase 1 Dose Escalating Trial of Bortezomib in Combination With Lenalidomide in Patients With Myelodysplasia

A Phase 1 study testing Bortezomib and Lenalidomide in people with Myelodysplasia, run by Massachusetts General Hospital 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 study proposes using bortezomib in cohorts of 3-6 patients at the doses of 0.7, 1, and 1.3 mg/m2 on days 1, 4, 8, and 11 to determine the MTD in combination with lenalidomide 10 mg a day, for 21 days of a 28 day treatment cycle for patients with myelodysplastic syndrome. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myelodysplasia
What is being tested?
Bortezomib and Lenalidomide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
2 sitesUnited States
Study dates
Nov 2007to Mar 2012
Phase
Phase 1
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

  • Patients may be untreated or previously treated.
  • Age > 18 years
  • Able to adhere to study schedule and other protocol requirements
  • Unequivocal clinicopathologic diagnosis of myelodysplastic syndrome, non 5q- deletion.
  • Patients may have had prior chemotherapy or radiotherapy for another malignancy or myelodysplasia as long as it was completed at least 4 weeks (6 weeks for nitrosureas) prior to initiation of therapy.
  • ECOG performance status of 0-2 (Appendix 10.3)
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  • Life expectancy greater than 3 months
  • Total bilirubin ≤ 2.0 mg/dl, ALT and AST ≤ 3 X the upper limit of normal (ULN), creatinine < 2.0 mg/dl all within 28 days prior to enrollment.
  • Patients must give voluntary written informed consent and HIPAA authorization before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
  • Absolute neutrophil count > 0.5 x 10 (9)/l
  • Platelet count > 30 x 10 (9)/l
  • Prior treatment with 5-azacytidine is encouraged, but not required.
  • Patients may have had prior treatment for MDS, including single agent lenalidomide or bortezomib.
  • Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50mIU/ml within 10-14 days prior to and within 24 hours of prescribing lenalidomide and must commit to abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control,at least 4 weeks before starting taking lenalidomide. FCBP must agree to ongoing pregnancy testing. Men must agree not to father a child and agree to use a latex condom during sexual contact with a female of child bearing potential even if they have had a successful vasectomy.
  • All study participants must be registered into the mandatory RevAssist Program®, and be willing and able to comply with the requirements of RevAssist®.

Who cannot join

  • Ejection fraction < 40%
  • Patients who have had a myocardial infarction within 6 months of enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant.
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the consent form.
  • Any condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
  • Patients with major surgery within the 28 days prior to trial enrollment.
  • Patients with ≥ Grade 2 peripheral neuropathy or active herpes infection
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  • Patients with an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, cirrhosis, chronic obstructive or restrictive pulmonary disease, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrythmia.
  • Patients with secondary MDS that require concurrent therapy for the primary cancer diagnosis.
  • The development of erythema nodosum as characterized by a desquamating rash while taking thalidomide or similar drugs.
  • Patient with hypersensitivity to bortezomib, boron or mannitol.
  • Female subject is pregnant or breast-feeding. . Lactating females must agree not to breast feed while taking lenalidomide.
  • Patient has received an investigational drug within 28 days of enrollment.
  • Known hypersensitivity to thalidomide or lenalidomide
  • Concurrent use of other anti-cancer agents or treatments.
  • Known positive for HIV

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: A Phase I Dose Escalating Study of Bortezomib and Lenalidomide in Patients With Untreated or Previously Treated, Primary and Secondary Non 5q- Del Myelodysplasia

This study proposes using bortezomib in cohorts of 3-6 patients at the doses of 0.7, 1, and 1.3 mg/m2 on days 1, 4, 8, and 11 to determine the MTD in combination with lenalidomide 10 mg a day, for 21 days of a 28 day treatment cycle for patients with myelodysplastic syndrome.

Read the detailed description

Currently, there are no curative therapies for myelodysplasia except for allogeneic stem cell transplantation. Both lenalidomide and bortezomib have activity as single agents in patients with myelodysplasia. This study proposes using bortezomib in cohorts of 3-6 patients at the doses of 0.7, 1, and 1.3 mg/m2 on days 1, 4, 8, and 11 to determine the MTD in combination withlenalidomide 10 mg a day, for 21 days of a 28 day treatment cycle. The planned bortezomib doses have been evaluated in previous Phase I clinical studies in similar patient populations and have been safe and well tolerated in a twice-weekly schedule of administration. Lenalidomide has been shown to have efficacy in myelodysplasia. The combination of lenalidomide and bortezomib has been used in patients with multiple myeloma.

Conditions
Myelodysplasia
Keywords
Myelodysplasia
Medical subject headings
Anemia, Refractory, with Excess of Blasts

What participants receive

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

  • BortezomibDrug

    Also called Velcade

    First cohort: Bortezomib 0.7mg/m2 IV on Days on Days 1, 4, 8, and 11. Patients may receive up to 9 cycles with each cycle lasting a total of 28 days

  • BortezomibDrug

    Also called Velcade

    Second cohort: Bortezomib 1mg/m2 IV on Days 1, 4, 8, and 11 Patients may receive up to 9 cycles with each cycle lasting a total of 28 days

  • BortezomibDrug

    Also called Velcade

    Third Cohort: Bortezomib 1.3mg/m2 IV on Days 1, 4, 8, and 11 of each cycle Patients may receive up to 9 cycles with each cycle lasting a total of 28 days

  • LenalidomideDrug

    Also called Revlimid

    Lenalidomide 10 mg PO QD on Days 1 -21 followed by a 7 day rest period

Study groups in NCT00580242
Study groupRoleWhat they receive
1ExperimentalThis is a Phase I dose escalation trial with three cohorts of 3-6 patients each plus 10 additional patients (up to a maximum total of 28 patients) treated at the candidate maximum tolerated dose.Cohorts will receive increasing doses of bortezomib at 0.7, 1, and 1.3 mg/m2 on days 1, 4, 8, and 11 in combination with lenalidomide at 10 mg a day for Days 1-21. Each cycle will be 28 days. Patients will receive up to 9 cycles of treatment, with efficacy assessed after 3, 6, and 9 cycles.
Receives: Drug: Bortezomib; Drug: Lenalidomide

What is being measured

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

  1. Establish the maximally tolerated dose of bortezomib, up to 1.3 mg/m2/day, that can be administered in combination with lenalidomide in patients with primary and secondary non 5q del myelodysplasia who are untreated or previously treated.

    Measured: 3, 6 and 9 months

Secondary outcomes (6)

  1. Assess efficacy in terms of the number of patients experiencing a decrease in blast percentage

    Measured: 3, 6 and 9 months

  2. Assess efficacy in terms of the number of patients experiencing a decrease in transfusion requirements

    Measured: 3, 6 and 9 months

  3. Determine the toxicity profile of bortezomib when used in combination with lenalidomide for patients with myelodysplasia

    Measured: 3, 6 and 9 months

  4. Determine the time (days) to transfusion independence

    Measured: 3, 6 and 9 months

  5. Determine the duration of response

    Measured: 3, 6 and 9 months

  6. Determine if molecular markers can predict responsiveness to treatment (for consenting patients)

    Measured: 3, 6 and 9 months

Timeline

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

  1. First posted24 Dec 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionMar 2012
  4. Study completionMar 2012

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00580242
Sponsor's protocol ID
07-006
Other IDs
RV-MDS-PI-0161
Status last verified
Mar 2012
First submitted
20 Dec 2007
Last updated
8 Mar 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bortezomib and Lenalidomide in people with Myelodysplasia, run by Massachusetts General Hospital 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 15 inclusion and 15 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 8 Mar 2012. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Establish the maximally tolerated dose of bortezomib, up to 1.3 mg/m2/day, that can be administered in combination with lenalidomide in patients with primary and secondary non 5q del myelodysplasia who are untreated or previously treated. (time frame: 3, 6 and 9 months). 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 NCT00580242.

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 8 Mar 2012.

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