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Multiple MyelomaPhase 2/3NCT00177047

Autologous Transplant for Multiple Myeloma

A Phase 2/3 study testing Stem Cell Transplant, Cyclophosphamide + Mesna and Melphalan in people with Multiple Myeloma, run by Masonic Cancer Center, University of Minnesota at 1 site 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 is a study of a regimen of melphalan and autologous stem cells for patients with multiple myeloma. We hypothesize that this particular regimen will improve the survival of these patients. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Multiple Myeloma
What is being tested?
Stem Cell Transplant, Cyclophosphamide + Mesna and Melphalan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
363 participants
Where
1 siteUnited States
Study dates
20 Apr 2004to 1 Aug 2020
Phase
Phase 2/3
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients meeting the Durie and Salmon criteria for initial diagnosis of multiple myeloma, requiring therapy and meeting one of the following:
  • After initial therapy in either first complete or partial remission or no objective response
  • After achieving initial response and later disease progression, patient will be eligible after subsequent therapy upon achievement of either complete or partial response
  • Is not eligible or has refused any protocols of higher priority
  • 18 - 75 years of age
  • Adequate organ function defined as:
Show all 14Show fewer
  • Hematologic: hemoglobin ≥ 8 gm/dl (untransfused), white blood cells (WBC) ≥ 3000/μl, absolute neutrophil count (ANC) ≥ 1500/μl, platelets ≥ 100,000/μl (untransfused)
  • Cardiac: no active ischemia, left ventricular ejection fraction > 45% by MUGA scan
  • Hepatic: bilirubin < 2.0 mg/dl, ALT < 3x the upper limit of normal
  • Pulmonary: FEV1-Forced Expiratory Volume in One Second AND Forced vital capacity (FVC) >50% predicted and Carbon Monoxide Diffusing Capacity (DLCO) (corrected) > 50% predicted
  • Performance status: Karnofsky performance of > 80%.
  • Free of active uncontrolled infection at the time of study entry.
  • At time of study enrollment > 4 weeks from prior myelosuppressive chemotherapy; and > 6 weeks from prior nitrosoureas.
  • Patients must exercise informed voluntary consent and sign a consent form approved by the University of Minnesota IRB: Human Subjects Committee.

Who cannot join

  • Patients will be ineligible if they have advanced myeloma refractory and unresponsive to salvage chemotherapy regimens.
  • Female patients who are pregnant (positive b-HCG) or breastfeeding will be excluded from study entry. In addition fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment, particularly after thalidomide will also be excluded from study entry.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Masonic Cancer Center, University of Minnesota

    Minneapolis, Minnesota, 55455

Other trials in United States

About this study

Official title: Autologous Transplantation for Multiple Myeloma

This is a study of a regimen of melphalan and autologous stem cells for patients with multiple myeloma. We hypothesize that this particular regimen will improve the survival of these patients.

Read the detailed description

Before starting treatment in this study, the bone marrow transplant (BMT) doctor will check the subject's general health. Subjects will have the following tests and evaluations to find out if they can participate:--Medical history and physical examination, including height and weight.--Blood tests (approximately 4 - 5 tablespoons) --Urine tests--Chest x-ray--Electrocardiogram (ECG or EKG)--Heart Scan (MUGA)--Pulmonary Function Test (PFT)--Bone marrow biopsies and aspirates. --If Female subjects of child-bearing age will have a serum pregnancy test performed. After eligible patients have been completely staged and exercised consent, they may undergo one cycle of chemotherapy (cyclophosphamide and Mesna) and growth factor (G-CSF) to effect cytoreduction and mobilization of PBSC for collection. All patients will receive high-dose melphalan followed by an autologous stem cell transplant (SCT). Blood tests will be performed frequently to evaluate the subject's response to treatment and possible side effects of treatment. If necessary, platelet and red cell transfusions will be given to maintain adequate levels and antibiotics will be given to treat or prevent infection. Subjects may also require intravenous nutritional support and pain medications during or after transplantation. The study coordinators will collect health information over three years. They will collect information every week for 100 days, then at 6 months, 1 year, 2 years, and 3 years.

Being tested
Stem Cell Transplant, Cyclophosphamide + Mesna, Melphalan, Granulocyte-colony stimulating factor
Keywords
stem cell transplantation, chemotherapy, multiple myeloma, autologous
Medical subject headings
Multiple Myeloma

What participants receive

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

  • Stem Cell TransplantProcedure or surgery

    Also called Bone Marrow Transplant

    As part of the stem cell transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover.

  • Cyclophosphamide + MesnaDrug

    Also called Cytoxan

    Cyclophosphamide: 4mg/m^2 + Mesna. Mesna is used to reduce the undesired side effects of certain chemotherapy drugs.

  • MelphalanDrug

    Also called Alkeran

    Administered intravenously 200 mg/m^2

  • Granulocyte-colony stimulating factorBiological

    Also called G-CSF

    Administered intravenously 10 ug/kg/day pretransplant then 5 ug/kg/day post-transplant.

Study groups in NCT00177047
Study groupRoleWhat they receive
Chemotherapy and Transplant TreatmentExperimentalPatients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m^2). Post-transplant maintenance therapy is then prescribed if appropriate.
Receives: Procedure: Stem Cell Transplant; Drug: Cyclophosphamide + Mesna; Drug: Melphalan; Biological: Granulocyte-colony stimulating factor

What is being measured

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

  1. Number of Participants Achieving a Complete Response

    Myeloma Response Definitions - Using International Uniform Response Criteria:

    Stringent Complete Response (sCR)requires, plus CR:

    • Normal free light chain ratio
    • Absence of clonal cells in bone marrow

    Complete Response (CR):

    • Absence of the original monoclonal paraprotein
    • <5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy
    • No increase in size or number of lytic bone lesions
    • Disappearance of soft tissue plasmacytomas.

    Measured: 100 Days post transplant

  2. Number of Participants Achieving a Complete Response

    Myeloma Response Definitions - Using International Uniform Response Criteria:

    Stringent Complete Response (sCR)requires, plus CR:

    • Normal free light chain ratio
    • Absence of clonal cells in bone marrow

    Complete Response (CR):

    • Absence of the original monoclonal paraprotein
    • <5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy
    • No increase in size or number of lytic bone lesions
    • Disappearance of soft tissue plasmacytomas.

    Measured: 6 months post transplant

  3. Number of Participants Achieving a Complete Response

    Myeloma Response Definitions - Using International Uniform Response Criteria:

    Stringent Complete Response (sCR)requires, plus CR:

    • Normal free light chain ratio
    • Absence of clonal cells in bone marrow

    Complete Response (CR):

    • Absence of the original monoclonal paraprotein
    • <5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy
    • No increase in size or number of lytic bone lesions
    • Disappearance of soft tissue plasmacytomas.

    Measured: 12 months post transplant

Secondary outcomes (16)

  1. Number of Patients With Extended Disease-free Survival

    Extended disease free survival will be defined as percentage of patients surviving more than 36 months without relapse or disease progression.

    Measured: 36 Months

  2. Number of Participants With Overall Survival

    The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate.

    Measured: 1 year

  3. Number of Participants With Overall Survival

    The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate.

    Measured: 2 years

  4. Number of Participants With Overall Survival

    The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate.

    Measured: 3 years

  5. Count of Participants Experiencing Transplant Related Mortality

    In the field of transplantation, toxicity is high and all deaths without previous relapse or progression are usually considered as related to transplantation.

    Measured: 1 year

  6. Number of Participants Experiencing Incidence of Relapse

    The return of disease after its apparent recovery/cessation.

    Measured: 1 year

  7. Number of Participants With Disease Progression

    Myeloma Response Definitions - Using International Uniform Response Criteria:

    Progressive Disease (PD)

    For patients not in CR or sCR, progressive disease requires one or more of the following:

    • >25% increase in the level of the serum monoclonal paraprotein, which must also be an absolute increase of at least 0.5 g/dL.
    • >25% increase in 24-hour urine protein electrophoresis, which must also be an absolute increase of at least 200 mg/24 hours.
    • Absolute increase in the difference between involved and uninvolved FLC levels (absolute increase must be >10 mg/dl), only in patients without measurable paraprotein in the serum and urine.
    • >25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10%.
    • Definite increase in the size of existing bone lesions or soft tissue plasmacytomas.

    Measured: 1 year

  8. Time to Progression

    Mean number of days among patients progressing

    Measured: 1 year

  9. Time to Relapse

    Mean number of days among patients relapsing

    Measured: 1 year

  10. Number of Participants With Absolute Neutrophil Recovery

    Hematologic recovery is defined by absolute neutrophil count (ANC) >2500/μl and platelets > 100,000/μl

    Measured: Day 42

  11. Time to Attainment of CR

    Mean (STD) among patients achieving complete remission (CR)

    Myeloma Response Definitions - Using International Uniform Response Criteria:

    Complete Response (CR):

    • Absence of the original monoclonal paraprotein
    • <5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy
    • No increase in size or number of lytic bone lesions
    • Disappearance of soft tissue plasmacytomas

    Measured: 12 months post transplant

  12. Time to Attainment of CR+PR

    Mean (STD) among patients achieving complete remission (CR) and partial remission (PR)

    Myeloma Response Definitions - Using International Uniform Response Criteria:

    Complete Response (CR):

    • Absence of the original monoclonal paraprotein
    • <5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy
    • No increase in size or number of lytic bone lesions
    • Disappearance of soft tissue plasmacytomas.

    Partial Response (PR):

    • Greater than or equal to 50% reduction in the level of the serum monoclonal paraprotein and/or reduction in 24 hour urinary monoclonal paraprotein either by greater than or equal to 90% or to <200 mg/24 hours in light chain disease.
    • If the only measurable non-bone marrow parameter is FLC, greater than or equal to 50% reduction in the difference between involved and uninvolved FLC levels or a 50% decrease in level

    Measured: 12 months post transplant

  13. Duration of Maintenance Treatment

    Measured: During study

  14. Dropout Rate From Maintenance Therapy

    Measured: Post transplant phase

  15. Number of Participants With Toxicities

    Occurrence of toxicities by first 100 days of transplant

    Measured: By first 100 days

  16. Number of Participants With Infections

    Occurrence of infections in the patients by the first 100 days of transplant

    Measured: By first 100 days

Timeline

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

  1. First posted15 Sep 2005 (estimated)
  2. Study start20 Apr 2004
  3. Primary completion1 Aug 2020
  4. Study completion1 Aug 2020

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 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
363 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00177047
Sponsor's protocol ID
2004LS001
Other IDs
MT2003-13, 0312M54569
Status last verified
Nov 2021
First submitted
13 Sep 2005
Last updated
9 Nov 2021
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Stem Cell Transplant, Cyclophosphamide + Mesna and Melphalan in people with Multiple Myeloma, run by Masonic Cancer Center, University of Minnesota at 1 site 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 14 inclusion and 2 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 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 9 Nov 2021). 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?

Number of Participants Achieving a Complete Response (time frame: 100 Days post transplant). The study lists 3 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 NCT00177047.

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 9 Nov 2021.

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