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Multiple MyelomaPhase 1/2RVDDNCT00724568

Combination Study of Revlimid®, Velcade® Dexamethasone and Doxil® (RVDD)for Newly Diagnosed Multiple Myeloma

A Phase 1/2 study testing Lenalidomide, Bortezomib and Dexamethasone in people with Multiple Myeloma, run by University of Michigan Rogel Cancer Center at 6 sites in 2 countries.

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 research study is evaluating an investigational combination of four drugs called Revlimid® (lenalidomide), Velcade® (bortezomib), Dexamethasone and Doxil® (RVDD) as a possible treatment for newly diagnosed multiple myeloma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Lenalidomide, Bortezomib and Dexamethasone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
6 sitesin 2 countries
Study dates
May 2008to 3 Sep 2014
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least 18 years of age at the time of consent
  • Measurable disease
  • All necessary baseline studies completed
  • LVEF (left ventricular ejection fraction) greater than or equal to 50 percent by MUGA (multigated acquisition scan) or ECHO (echocardiogram)
  • Must be able to adhere to study visit schedule

Who cannot join

  • Greater than or equal to grade 2 peripheral neuropathy on clinical examination within 14 days of enrollment
  • Renal insufficiency
  • Evidence of mucosal or internal bleeding and/ or platelet refractory.
  • Absolute neutrophil count less than 1000 cells/mm^2 within 14 days of enrollment.
  • Acceptable labs
  • Concomitant medications that include corticosteroids
Show all 21Show fewer
  • Myocardial infarction within 6 months prior to enrollment, uncontrolled angina, severe uncontrolled ventricular arrhythmias
  • Clinically relevant active infection or serious medical condition that places the subject at unacceptable risk
  • Any condition, including laboratory values that places the subject at an unacceptable risk
  • Another malignancy within 3 years of enrollment, with the exception of the complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low risk prostate cancer after curative therapy
  • Hypersensitivity to bortezomib, boron, or mannitol or any of the components of DOXIL
  • Female subject that is pregnant or breastfeeding.
  • Can not have received any other investigational drugs within 14 days of enrollment
  • Serious medical or psychiatric illness
  • Uncontrolled diabetes mellitus
  • Hypersensitivity to acyclovir or similar antiviral drug
  • POEMS (plasma cell dyscrasia with polyneuropathy)
  • Known HIV
  • Known hepatitis B or C
  • Known intolerance to steroid therapy
  • Known hypersensitivity to required prophylactic mediations

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

United States5 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Dana Farber Cancer Institute (and Massachusetts General)

    Boston, Massachusetts, 02115

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637

  • The Ohio State University Medical Center

    Columbus, Ohio, 43210

Other trials in United States

Canada1 site

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Multi-Institutional Phase I/II Study of Revlimid® (Lenalidomide), Velcade® (Bortezomib), Dexamethasone, and Doxil®, (RVDD) Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma

This research study is evaluating an investigational combination of four drugs called Revlimid® (lenalidomide), Velcade® (bortezomib), Dexamethasone and Doxil® (RVDD) as a possible treatment for newly diagnosed multiple myeloma.

Read the detailed description

During the Phase I portion of this clinical trial, the doses of Revlimid® and Doxil® will be increased until the best and safest amount (or dose) is identified in combination with Velcade® and Dexamethasone. "Investigational" means that the drug combination is still being studied and that research doctors are trying to find out more about it such as the safest dose to use, the side effects it may cause and how effective the Velcade®, Doxil®, Dexamethasone and Revlimid® investigational combination is for treating newly diagnosed multiple myeloma. In this clinical trial we are looking for the highest dose of the combination that can be given safely and see how well it works as a combination in newly diagnosed patients.

Each of these drugs, Velcade®, Doxil®, Dexamethasone and Revlimid® are approved by the FDA (U.S. Food and Drug Administration). They have not been approved in this combination for use for your type of cancer or any other type of cancer. Velcade® is currently approved by the United States Food and Drug Administration (US FDA) for the treatment of multiple myeloma patients who have received at least one prior therapy. Doxil® has recently been approved by the US FDA for multiple myeloma in combination with Velcade® in patients who have not previously received Velcade® and have received at least one prior therapy. Dexamethasone is commonly used, either alone, or in combination with other drugs, to treat multiple myeloma. Revlimid® is currently approved by the US FDA in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least 1 prior therapy.

After the Phase I clinical trial defines the safest doses of Velcade®, Doxil®, Dexamethasone and Revlimid® that can be taken together, the research study will move on to its second portion, a Phase II clinical trial. The Phase II portion of the clinical trial will test the clinical effectiveness of the best dose combination of the four drugs.

Keywords
Newly Diagnosed Multiple Myeloma
Medical subject headings
Multiple Myeloma

What participants receive

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

  • LenalidomideDrug

    Also called Revlimid

    Patients will be treated with Revlimid on days 1-14 in 3-week cycles for 4-8 cycles.

  • BortezomibDrug

    Also called Velcade

    Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11

  • DexamethasoneDrug

    Patients will be treated with Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels.

  • DoxilDrug

    Patients will be treated with Doxil on day 4.

Study groups in NCT00724568
Study groupRoleWhat they receive
Combination Drug TherapyExperimentalPatients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles. To determine the MTD of the combination of Revlimid, Velcade, dexamethasone, and Doxil, four dose levels are planned.
Receives: Drug: Lenalidomide; Drug: Bortezomib; Drug: Dexamethasone; Drug: Doxil

What is being measured

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

  1. Maximum Tolerated Dose (MTD) of Combination Therapy With VELCADE, Dexamethasone, and Doxil, (RVDD)

    Dose Level 1:

    15 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12* and 20 mg/m2 Doxil daily on day 4

    Dose Level 2:

    20 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12* and 20 mg/m2 Doxil daily on day 4

    Dose Level 3:

    25 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12* and 20 mg/m2 Doxil daily on day 4

    Dose Level 4:

    25 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12* and 30 mg/m2 Doxil daily on day 4

    Measured: 1 month post treatment

Secondary outcomes (1)

  1. The Percentage of Patients That Achieved Partial or Complete Response to Treatment.

    Partial Response:

    • 50% reduction in the level of serum monoclonal protein for at least two determinations six weeks apart.
    • If present, reduction in 24-hour urinary light chain excretion by either, greater than or equal to 90%, or to <200 mg for at least two determinations six weeks apart.
    • 50% reduction in the size of soft tissue plasmacytomas (by clinical or radiographic examination) for at least six weeks.
    • No increase in size or number of lytic bone lesions (development of compression fracture does not exclude response).

    Complete Response:

    • Disappearance of the original monoclonal protein from the blood and urine on at least two determinations for a minimum of six weeks.
    • <5% plasma cells in the bone marrow on at least two determinations for a minimum of six weeks.
    • No increase in the size or number of lytic bone lesions.

    Measured: 24 weeks (8, 21-day cycles)

Timeline

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

  1. First posted29 Jul 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionApr 2009
  4. Study completion3 Sep 2014

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00724568
Sponsor's protocol ID
UMCC 2007.098
Other IDs
HUM 12962
Acronym
RVDD
Status last verified
May 2017
First submitted
11 Apr 2008
Last updated
2 Jun 2017
Data monitoring committee
Yes

Publications

  • Jakubowiak AJ, Griffith KA, Reece DE, Hofmeister CC, Lonial S, Zimmerman TM, Campagnaro EL, Schlossman RL, Laubach JP, Raje NS, Anderson T, Mietzel MA, Harvey CK, Wear SM, Barrickman JC, Tendler CL, Esseltine DL, Kelley SL, Kaminski MS, Anderson KC, Richardson PG. Lenalidomide, bortezomib, pegylated liposomal doxorubicin, and dexamethasone in newly diagnosed multiple myeloma: a phase 1/2 Multiple Myeloma Research Consortium trial. Blood. 2011 Jul 21;118(3):535-43. doi: 10.1182/blood-2011-02-334755. Epub 2011 May 19.

    PubMed 21596852

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Lenalidomide, Bortezomib and Dexamethasone in people with Multiple Myeloma, run by University of Michigan Rogel Cancer Center at 6 sites in 2 countries.

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 5 inclusion and 21 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 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Canada. 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 combined 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.

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 10 Sep 2014). 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?

Maximum Tolerated Dose (MTD) of Combination Therapy With VELCADE, Dexamethasone, and Doxil, (RVDD) (time frame: 1 month post treatment). 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 NCT00724568, 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 2 Jun 2017.

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