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Refractory Multiple MyelomaPhase 2NCT00006244

Melphalan, Peripheral Stem Cell Transplantation, and Interleukin-2 Followed by Interferon Alfa in Treating Patients With Advanced Multiple Myeloma

A Phase 2 study testing melphalan, recombinant interferon alfa and aldesleukin in people with Refractory Multiple Myeloma and Stage I Multiple Myeloma, run by Fred Hutchinson Cancer Center 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 phase II trial studies the effectiveness of melphalan, peripheral stem cell transplantation, and interleukin-2 followed by interferon alfa in treating patients who have advanced multiple myeloma (MM). Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study

Who is it for?
Ages 18 to 69 years
What is being tested?
melphalan, recombinant interferon alfa and aldesleukin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
Feb 2000to Apr 2016
Phase
Phase 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 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient must be less than 70 years old
  • Patients with advanced Multiple Myeloma that meet the eligibility requirements for mobilization/debulking with Cytoxan/VP-16/G-CSF, Cytoxan/Taxol/G-CSF, or Cytoxan/G-CSF (according to protocol 506.03); if clinically indicated a lower dose of cytoxan than 4g/m2 may be used for mobilization based on the attending's discretion; also, if the patients had previously collected PBSC of sufficient number in the past and meet the other eligibility requirements, they may be entered on this study after approval by the PI
  • Patients with advanced Multiple Myeloma that have an identical syngeneic twin for donation of PBSCs
  • Patients have advanced Multiple Myeloma if they were diagnosed initially with stage II or III disease or had stage I disease that progressed after initial therapy or failed to respond to therapy
  • Syngeneic Donor Inclusion:
  • Donor and patient have adequate documentation that donor and recipient are syngeneic; including ABO typing, HLA typing and VNTR studies
  • Donor > 20 kg
  • Donor meets eligibility to donate according to Standard Practice Guidelines

Who cannot join

  • Patient's age >= 70
  • Karnofsky score less than 80
  • A left ventricular ejection fraction less than 50%; Patients with congestive heart disease, history of myocardial infarction (MI), coronary artery disease or any arrhythmia history
  • Total bilirubin > 1.5 mg/ml (unless history of Gilbert's disease)
  • Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) > 2 x upper limit of normal
  • Estimated creatinine clearance < 60 ml/min or creatinine serum > 2.0 mg/dl
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  • Pregnancy
  • Seropositivity for human immunodeficiency virus
  • Patients who cannot give informed consent
  • Secondary malignancies other than basal cell carcinoma of the skin or carcinoma in situ within the last five years
  • History of seizures or requirement for medicines, such as haldol, for controlling mental disorders
  • Concurrent need for corticosteroid therapy
  • Active connective tissue disease
  • Pleural effusion, pericardial effusion or ascites
  • Patients allergic to gentamicin
  • Patients with positive PCR for hepatitis C or hepatitis B
  • Patients with hypersensitivity to E. coli - derived preparations
  • Patients with systemic infection at time of IL2 therapy
  • Patients who previously have had more than 50% of their pelvic area irradiated
  • Patients with pulmonary function tests that show diffusion capacity (corrected) < 60%, and/or forced expiratory volume in 1 second (FEV1) < 65% of predicted

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: Immunotherapy for Autologous/Syngeneic Peripheral Blood Stem Cell (PBSC) Transplant Patients as Treatment for Advanced Multiple Myeloma

This phase II trial studies the effectiveness of melphalan, peripheral stem cell transplantation, and interleukin-2 followed by interferon alfa in treating patients who have advanced multiple myeloma (MM). Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Interleukin-2 (IL2) may stimulate a person's white blood cells to kill multiple myeloma cells. Interferon alfa may interfere with the growth of cancer cells

Read the detailed description

PRIMARY OBJECTIVES:

  1. Evaluate initial response to therapy, time to disease progression, and overall survival in MM patients treated with melphalan, IL2- incubated peripheral blood stem cells, and sequential IL2.

SECONDARY OBJECTIVES:

  1. Evaluate grade 3-4 toxicities encountered by younger (< 56 years old) and older (>56 years old) advanced multiple myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2.

OUTLINE:

Patients receive melphalan intravenously (IV) over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa subcutaneously (SC) 3 times a week in the absence of disease progression or unacceptable toxicity.

Being tested
melphalan, recombinant interferon alfa, aldesleukin, in vitro-treated peripheral blood stem cell transplantation
Medical subject headings
Multiple Myeloma

What participants receive

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

  • melphalanDrug

    Also called Alkeran, CB-3025, L-PAM, L-phenylalanine mustard

    Given IV

  • recombinant interferon alfaBiological

    Also called Alferon N, alpha interferon, IFN-A, Intron A

    Given SC

  • aldesleukinBiological

    Also called IL-2, Proleukin, recombinant human interleukin-2, recombinant interleukin-2

    Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion

  • in vitro-treated peripheral blood stem cell transplantationProcedure or surgery

    Also called in vitro-treated PBPC transplantation, in vitro-treated PBSC, in vitro-treated peripheral blood progenitor cell transplantation, PBPC transplantation, in vitro-treated

    Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion

Study groups in NCT00006244
Study groupRoleWhat they receive
Treatment (immunotherapy)ExperimentalPatients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.
Receives: Drug: melphalan; Biological: recombinant interferon alfa; Biological: aldesleukin; Procedure: in vitro-treated peripheral blood stem cell transplantation

What is being measured

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

  1. Overall Survival

    Overall survival in Multiple Myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2 and interferon maintenance.

    Measured: 12.9 Median Years

  2. Initial Response to Therapy

    Evaluate initial response to therapy (complete remission, partial remission, stable response, or progression of disease)

    Measured: Evaluated at Day +84-90 Post-Transplant

  3. Time to Disease Progression

    Measured: 12.9 years (median)

  4. Proportion of Patients Alive and in Remission

    Measured: 12.9 Median Years

Secondary outcomes (2)

  1. Number of Patients <56 Years Old Experiencing Grade 3-4 Regimen Related Toxicity

    Grade 3-4 toxicities by the Bearman common toxicity criteria, encountered by younger (< 56 years old) advanced multiple myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2.

    Measured: First 100 days post-transplant

  2. Number of Patients ≥56 Years Old Experiencing Grade 3-4 Regimen Related Toxicity

    Grade 3-4 toxicities by the Bearman common toxicity criteria, encountered by older (≥56 years old) advanced multiple myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2.

    Measured: First 100 days post-transplant

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startFeb 2000
  3. Primary completionApr 2016
  4. Study completionApr 2016

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006244
Sponsor's protocol ID
1461.00
Other IDs
NCI-2011-01313
Status last verified
Jun 2017
First submitted
11 Sep 2000
Last updated
12 Jul 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing melphalan, recombinant interferon alfa and aldesleukin in people with Refractory Multiple Myeloma and Stage I Multiple Myeloma, run by Fred Hutchinson Cancer Center 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 8 inclusion and 20 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 12 Jul 2017. 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 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?

Yes. Results are posted in the registry (first posted 16 May 2017). 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?

Overall Survival (time frame: 12.9 Median Years). The study lists 4 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 NCT00006244.

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 12 Jul 2017.

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