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Multiple Myeloma and Plasma Cell NeoplasmPhase 1/2NCT00477750

Melphalan, Prednisone, and Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma

A Phase 1/2 study testing lenalidomide, melphalan and prednisone in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Mayo Clinic at 3 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

RATIONALE: Drugs used in chemotherapy, such as melphalan, prednisone, and lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
lenalidomide, melphalan and prednisone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
3 sitesUnited States
Study dates
Jun 2005to 5 Aug 2013
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

DISEASE CHARACTERISTICS:

  • Diagnosis of multiple myeloma
  • Newly diagnosed disease
  • Requires treatment, in the judgment of the treating physician
  • Not a candidate for (or patient declines) autologous stem cell transplantation
  • Meets 1 of the following criteria:
  • Measurable disease, defined by any of the following:
  • Serum monoclonal protein ≥ 1 g/dL
  • Urine protein monoclonal light chain ≥ 200 mg/24 hours by electrophoresis
  • Measurable serum free light chains ≥ 10 mg/dL, kappa or lambda, AND κ/λ ratio is abnormal (if serum and urine are not measurable as defined above)
  • Evaluable disease, defined as monoclonal bone marrow plasmacytosis ≥ 30%

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-3
  • Life expectancy > 3 months
  • ANC ≥ 1,500/mm³
  • Bilirubin ≤ 2.0 mg/dL
  • Alkaline phosphatase ≤ 3 times upper limit of normal (ULN)
  • AST ≤ 3 times ULN
  • Creatinine ≤ 3.0 mg/dL
  • Platelet count ≥ 100,000/mm³
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 effective methods of contraception, including ≥ 1 highly effective method, ≥ 4 weeks before and during study treatment
  • No uncontrolled infection
  • No peripheral neuropathy ≥ grade 2
  • No serious medical condition, laboratory abnormality, or psychiatric illness that would preclude study compliance
  • No other active malignancy except for nonmelanoma skin cancer or carcinoma in situ
  • Prior malignancy allowed if treated with curative intent and is free of disease for a period appropriate for that cancer
  • No known hypersensitivity to thalidomide
  • No known HIV positivity
  • No infectious hepatitis A, B or C
  • No history of deep vein thrombosis or other medical condition requiring the use of warfarin
  • Able to take daily prophylactic acetylsalicylic acid (81 or 325 mg)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy for treatment of multiple myeloma
  • No prior lenalidomide
  • No other concurrent anticancer agents or treatments
  • No concurrent steroids except prednisone ≤ 20 mg/day (or the equivalent) for concurrent illness or adrenal replacement therapy
  • No other concurrent investigational therapy or agent for treatment of multiple myeloma
  • No concurrent warfarin

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259-5499

Other trials in United States

About this study

Official title: Phase I/II Trial of Melphalan, Prednisone Plus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Stem Cell Transplant

RATIONALE: Drugs used in chemotherapy, such as melphalan, prednisone, and lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of melphalan and lenalidomide when given together with prednisone and to see how well they work in treating patients with newly diagnosed multiple myeloma.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of melphalan and lenalidomide in combination with prednisone in patients with newly diagnosed multiple myeloma.
  • Determine the response rate in patients treated with this regimen. Secondary
  • Determine the toxicity of this regimen in these patients. OUTLINE: This is a dose-escalation study of melphalan and lenalidomide followed by a phase II study.
  • Phase I: Patients receive oral melphalan and oral prednisone daily on days 1-4. Patients also receive oral lenalidomide daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of melphalan and lenalidomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

  • Phase II: Patients receive oral melphalan and oral lenalidomide as in phase I at the MTD. Patients also receive oral prednisone as in phase I. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 3 years.

Keywords
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.

  • lenalidomideDrug

    Phase I - dose escalating: 5mg level -1, 10mg level 0, 10mg level 1, 15mg level 2, 20mg level 3, 25mg level 4, orally days 1-21 every 28 days until progression

    Phase II - 10 mg orally days 1-21 every 28 days until progression

  • melphalanDrug

    Phase I - dose escalating: 5mg/m^2 dose level -1, 5 mg/m^2 dose level 0, 8 mg/m^2 dose level 1 - 4, daily x 4 orally days every 28 days until progression

    Phase II - 5mg/m^2 orally days 1-4 every 28 days until progression

  • prednisoneDrug

    60mg/m^2, orally days 1-4 every 28 days until progression

Study groups in NCT00477750
Study groupRoleWhat they receive
Treatment (Lenalidomide, Melphalan, Prednisone)ExperimentalIntervention: Drug: lenalidomide Dose determined by Phase I treatment schedule. Taken orally days 1-21 every 28 days until progression Intervention: Drug: melphalan Dose determined by Phase I treatment schedule. Taken orally days 1-4 every 28 days until progression Intervention: Drug: prednisone 60mg/m^2, orally days 1-4 every 28 days until progression
Receives: Drug: lenalidomide; Drug: melphalan; Drug: prednisone

What is being measured

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

  1. Patients With Overall Confirmed Response

    Response that was confirmed on 2 consecutive evaluations.>

    • Complete Response (CR): Complete disappearance of M-protein from serum and urine on immunofixations, normalization of Free Light Chain (FLC) ratio and <=5% plasma cells in bone marrow>
    • Very Good Partial Response (VGPR): >=90% reduction in serum M-spike, Urine M-spike <100mg per 24 hours>
    • Partial Response (PR): >=50% reduction in serum M-spike, Urine M-spike >=90% reduction or < 200mg per 24 hours, or >=50% decrease in difference between involved and uninvolved FLC levels or 50% decrease in bone marrow plasma cells

    Measured: Every cycle during treatment

Secondary outcomes (4)

  1. Progression-free Survival

    Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression was defined as any one or more of the following:

    An increase of 25% from lowest confirmed response in:

    • Serum M-component (absolute increase >= 0.5g/dl)
    • Urine M-component (absolute increase >= 200mg/24hour
    • Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl
    • Bone marrow plasma cell percentage (absolute increase of >=10%)

    Measured: registration to progressive disease (up to 3 years)

  2. Overall Survival (OS) at 3 Years

    OS was defined as the time from registration to death due to any cause. Patients who were alive were censored at date of last follow-up. The overall survival at 3 years (a percentage) is reported below.

    Measured: registration to death (up to 3 years)

  3. Duration of Response (DOR)

    Duration of response was calculated from documentation of first response to date of progression in the subset of patients who responded. Patients without progression were censored at the date of last tumor evaluation.

    Measured: from first response to progression or death (up to 3 years)

  4. Percentage of Participants With Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (v3)

    The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below.

    Measured: Every cycle during treatment up to 3 years

Timeline

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

  1. First posted24 May 2007 (estimated)
  2. Study startJun 2005
  3. Primary completionApr 2008
  4. Study completion5 Aug 2013

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
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00477750
Sponsor's protocol ID
CDR0000546642
Other IDs
P30CA015083, MC038A, 2387-04, RV-MM-PI-025
Status last verified
Oct 2015
First submitted
23 May 2007
Last updated
11 Oct 2019

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing lenalidomide, melphalan and prednisone in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Mayo Clinic at 3 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 11 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 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 13 Dec 2010). 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?

Patients With Overall Confirmed Response (time frame: Every cycle during 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 NCT00477750.

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 2019.

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