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Multiple Myeloma and Plasma Cell NeoplasmPhase 2NCT00305812

Lenalidomide and Melphalan in Treating Patients With Previously Untreated Multiple Myeloma

A Phase 2 study testing dexamethasone, lenalidomide and melphalan in people with Multiple Myeloma and Plasma Cell Neoplasm, run by NCIC Clinical Trials Group at 14 sites in Canada.

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: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. It may also stimulate the immune system in different ways and stop cancer cells from growing. Read more about this study

Who is it for?
Ages 18 to 120 years
What is being tested?
dexamethasone, lenalidomide and melphalan
How many people
51 participants
Where
14 sitesCanada
Study dates
9 Mar 2006to 30 Jun 2008
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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed multiple myeloma by one of the following:
  • Biopsy of an osteolytic lesion or soft tissue tumor composed of plasma cells
  • Bone marrow aspirate and/or biopsy demonstrating ≥ 10% plasmacytosis
  • Bone marrow < 10% plasma cells but with ≥ 1 bony lesion AND meets the M-protein criteria
  • Ineligible for stem cell transplantation due to any of the following:
  • Advanced age
  • Comorbid illness
  • Patient preference
  • Previously untreated disease
  • Measurable (i.e., quantifiable) serum M-component of IgG, IgA, IgD, or IgE at initial diagnosis OR, if only light-chain disease is present (urine M-protein only), urinary excretion of light-chain protein (Bence Jones) ≥ 1.0 g/24 hours at initial diagnosis
  • No nonsecretory myeloma

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 12 months
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 150,000/mm^3
  • Creatinine ≤ 3 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • AST and/or ALT ≤ 1.5 times ULN
  • Alkaline phosphatase ≤ 1.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 methods of effective contraception during and for 4 weeks after completion of study treatment
  • No other malignancies within the past 5 years, except adequately treated nonmelanoma skin cancer or curatively treated in situ cancer of the cervix
  • No hypersensitivity to thalidomide or its components, including the development of a desquamating rash
  • No other serious illness or medical condition that would preclude study participation
  • No history of significant neurologic or psychiatric disorder that would preclude informed consent
  • No known HIV positivity
  • No pre-existing cardiovascular conditions and/or symptomatic cardiac dysfunction, including any of the following:
  • Significant cardiac event (including symptomatic heart failure or angina) within 3 months prior to randomization
  • Any cardiac disease that increases risk for ventricular arrhythmia
  • History of ventricular arrhythmia that was symptomatic or required treatment, including any of the following:
  • Multifocal premature ventricular contractions
  • Bigeminy
  • Trigeminy
  • Ventricular tachycardia/fibrillation/flutter/arrhythmia NOS

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or corticosteroids for the treatment of multiple myeloma
  • Prior corticosteroids for the treatment of hypercalcemia or spinal cord compression allowed provided maximum levels have not been reached (i.e.,< 120 mg for dexamethasone or < 792 mg for prednisone)
  • Prior radiotherapy to single sites for pain control or local plasmacytoma allowed
  • Prior or concurrent bisphosphonates allowed
  • At least 28 days since prior investigational anticancer agents or therapy
  • No concurrent corticosteroids above physiologic replacement doses
  • Concurrent radiotherapy to sites of active myeloma with pain or neurologic compromise allowed
  • No concurrent filgrastim (G-CSF) on day 1 of course 1
  • No other concurrent anticancer therapy
  • No other concurrent investigational therapy

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Canada14 sites

  • Tom Baker Cancer Centre - Calgary

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute at University of Alberta

    Edmonton, Alberta, T6G 1Z2

  • Hopital Charles Lemoyne

    Greenfield Park, Quebec, J4V 2H1

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V7

  • Margaret and Charles Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • British Columbia Cancer Agency - Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • London Regional Cancer Program at London Health Sciences Centre

    London, Ontario, N6A 4L6

  • Moncton Hospital

    Moncton, New Brunswick, E1C 6Z8

  • Hopital Notre-Dame du CHUM

    Montreal, Quebec, H2L 4M1

  • McGill Cancer Centre at McGill University

    Montreal, Quebec, H2W 1S6

  • Allan Blair Cancer Centre at Pasqua Hospital

    Regina, Saskatchewan, S4T 7T1

  • Algoma District Cancer Program at Sault Area Hospital

    Sault Ste. Marie, Ontario, P6A 2C4

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • Humber River Regional Hospital - Weston

    Toronto, Ontario, M9N 1N8

Other trials in Canada

About this study

Official title: A Randomized Phase II Dose Finding Study of Revlimid™ and Melphalan in Patients With Previously Untreated Multiple Myeloma

RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. It may also stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with melphalan may kill more cancer cells.

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

Read the detailed description

OBJECTIVES:

Primary

  • Evaluate the tolerability of 2 different doses of lenalidomide when administered with melphalan in patients with previously untreated multiple myeloma who are not planning to undergo future autologous stem cell transplantation.

Secondary

  • Characterize the toxicity profile of lenalidomide in combination with melphalan.
  • Determine tumor response in these patients after 2 and 12 courses of induction therapy with lenalidomide and melphalan and after 6 months of maintenance therapy with dexamethasone.
  • Determine progression-free and overall survival of these patients.
  • Determine time to dose modification and time to dose discontinuation in these patients.

Tertiary

  • Examine wnt pathway inhibition in response to lenalidomide on pre- and post-treatment bone marrow and blood samples using enzyme-linked immunosorbent assay (ELISA), gene expression profiling, drosophila-based chemical genetics, and surface-enhanced laser desorption/ionization mass spectrometry (SELDI MS) proteomics.

OUTLINE: This is a multicenter, randomized, open-label, dose-finding study of lenalidomide.

Prior to randomization, 6 patients receive oral lenalidomide at a lower dose (same dose to be used in arm I) once daily on days 1-21 and oral melphalan once daily on days 1-4. Treatment repeats every 28 days for 3 courses. If no unacceptable toxicity occurs, the trial will proceed and randomization will occur.

  • Induction therapy: Patients are randomized to 1 of 2 dose levels of lenalidomide.
  • Arm I: Patients receive oral lenalidomide once daily on days 1-21 and oral melphalan once daily on days 1-4.
  • Arm II: Patients receive oral lenalidomide as in arm I, but at a lower dose, and melphalan as in arm I, but at a higher dose.

Treatment in both arms repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After 12 courses of induction therapy, patients in both arms without progressive disease proceed to maintenance therapy.

  • Maintenance therapy: Patients receive oral dexamethasone once daily on days 1-4. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 4 weeks and then every 2 months thereafter.

PROJECTED ACCRUAL: A total of 92 patients will be accrued for this study.

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.

What is being measured

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

  1. Incidence of dose-limiting toxicity within first 3 courses of treatment

Secondary outcomes (7)

  1. Toxicity

  2. Disease response after 2 courses, 6 courses, 12 courses, and 6 months of maintenance therapy

  3. Time to progression

  4. Overall survival

  5. Duration of disease-free interval

  6. Time to dose modification

  7. Time to dose discontinuation

Timeline

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

  1. First posted22 Mar 2006 (estimated)
  2. Study start9 Mar 2006
  3. Primary completion30 Jun 2008
  4. Study completion30 Jun 2008

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00305812
Sponsor's protocol ID
MY11
Other IDs
CAN-NCIC-MY11, CELGENE-CAN-NCIC-MY11, CDR0000466184
Status last verified
Mar 2020
First submitted
21 Mar 2006
Last updated
4 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • White DJ, Paul N, Macdonald DA, Meyer RM, Shepherd LE. Addition of lenalidomide to melphalan in the treatment of newly diagnosed multiple myeloma: the National Cancer Institute of Canada Clinical Trials Group MY.11 trial. Curr Oncol. 2007 Apr;14(2):61-5. doi: 10.3747/co.2007.107.

    PubMed 17576467

  • White DJ, Bahlis NJ, Marcellus DC, et al.: Phase II testing of lenalidomide plus melphalan for previously untreated older patients with multiple myeloma: the NCIC CTG MY.11 trial. [Abstract] Blood 112 (11): A-2767, 2008.

  • White DJ, Kovacs MJ, Belch A, et al.: Phase II testing of lenalidomide plus melphalan for previously untreated older patients with multiple myeloma: toxicity data from the NCIC CTG MY.11 trial. [Abstract] Blood 110 (11): A-189, 2007.

  • White DJ, Bahlis NJ, Marcellus DC, Belch A, Stewart AK, Chen C, Kovacs MJ, Macdonald DA, Reece DE, Reiman T, Harnett E, Meyer RM, Chapman JA, Couban S. Lenalidomide plus melphalan without prednisone for previously untreated older patients with multiple myeloma: a phase II trial. Clin Lymphoma Myeloma Leuk. 2013 Feb;13(1):19-24. doi: 10.1016/j.clml.2012.08.009. Epub 2012 Nov 7.

    PubMed 23141150

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing dexamethasone, lenalidomide and melphalan in people with Multiple Myeloma and Plasma Cell Neoplasm, run by NCIC Clinical Trials Group at 14 sites in Canada.

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 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in 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 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.

What does the primary outcome measure?

Incidence of dose-limiting toxicity within first 3 courses of 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 NCT00305812, which also lists 4 linked publications.

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 4 Aug 2023.

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