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Multiple MyelomaPhase 2NCT00028600

Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma

A Phase 2 study testing filgrastim, CD34+ cells and cyclophosphamide in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Alliance for Clinical Trials in Oncology at 15 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: Peripheral blood stem cell transplant using stem cells from the patient or a donor may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. The donated stem cells may also help destroy any remaining cancer cells (graft-versus-tumor effect). Read more about this study

Who is it for?
Ages Up to 64 years
Conditions the study is for
Multiple Myeloma, Plasma Cell Neoplasm
What is being tested?
filgrastim, CD34+ cells and cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
15 sitesUnited States
Study dates
Nov 2001to Feb 2010
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 Up to 64 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

DISEASE CHARACTERISTICS:

  • Diagnosis of active multiple myeloma that requires treatment
  • Durie-Salmon stage I, II, and III
  • No more than 1 progression after initial therapy
  • Must have HLA-identical sibling donor (6/6) by serologic typing (A, B, DR)
  • No syngeneic donors
  • Must also be enrolled on protocol CLB-8461 (Cytogenetic Studies in Acute Leukemia)

PATIENT CHARACTERISTICS:

Age:

  • Under 65

Performance status:

  • NCI CTC 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count greater than 500/mm^3
  • Platelet count greater than 50,000/mm^3

Hepatic:

  • Bilirubin less than 2 mg/dL
  • AST less than 3 times upper limit of normal (ULN)
  • Alkaline phosphatase less than 3 times ULN

Renal:

  • Creatinine less than 2 mg/dL
  • Creatinine clearance greater than 40 mL/min

Cardiovascular:

  • LVEF at least 30% by MUGA scan

Pulmonary:

  • DLCO greater than 40% of predicted
  • No symptomatic pulmonary disease

Other:

  • HIV negative
  • No uncontrolled diabetes mellitus
  • No active serious infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 4 weeks since prior chemotherapy
  • Prior alkylating-agent therapy allowed if no more than 12 months duration

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 4 weeks since prior radiotherapy

Surgery:

  • At least 4 weeks since prior surgery

Other:

  • All prior therapy no more than 18 months duration

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7295

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

    Columbus, Ohio, 43210-1240

  • Union Hospital Cancer Program at Union Hospital

    Elkton MD, Maryland, 21921

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1002

  • Tunnell Cancer Center at Beebe Medical Center

    Lewes, Delaware, 19958

  • Mount Sinai Medical Center

    New York, New York, 10029

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224-1791

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94115

  • Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis

    St Louis, Missouri, 63110

  • Cancer Institute of New Jersey at Cooper - Voorhees

    Voorhees Township, New Jersey, 08043

  • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Wake Forest University Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157-1096

Other trials in United States

About this study

Official title: Autologous Followed By Non-Myeloablative Allogeneic Transplant For Multiple Myeloma

RATIONALE: Peripheral blood stem cell transplant using stem cells from the patient or a donor may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. The donated stem cells may also help destroy any remaining cancer cells (graft-versus-tumor effect).

PURPOSE: This phase II trial is studying how well autologous peripheral stem cell transplant followed by donor peripheral stem cell transplant works in treating patients with multiple myeloma.

Read the detailed description

OBJECTIVES:

  • Determine whether autologous peripheral blood stem cell transplantation (PBSCT) followed by non-myeloablative allogeneic PBSCT is associated with no more than 20% treatment-related mortality rates at 6 months in patients with multiple myeloma.
  • Determine the response rate of patients treated with this regimen.
  • Determine the percent donor chimerism in patients treated with this regimen.
  • Determine the rate of graft-vs-host disease in patients treated with this regimen.
  • Determine the toxic effects of this regimen in these patients.
  • Determine the disease-free and overall survival of patients treated with this regimen.
  • Determine whether abnormal cytogenetics at presentation correlate with poor response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive cyclophosphamide IV over 1-2 hours on day 1 and filgrastim (G-CSF) subcutaneously (SC) beginning on day 5 and continuing until peripheral blood stem cell (PBSC) collection is complete.

Approximately 2-4 weeks after PBSC collection, patients receive melphalan IV over 15-30 minutes on day -2. Patients then undergo autologous PBSC transplantation (PBSCT) on day 0. Patients receive G-CSF SC beginning on day 5 and continuing until blood counts recover.

Approximately 2-4 months after autologous PBSCT, patients receive fludarabine IV over 30 minutes on days -7 to -3 and cyclophosphamide IV over 1 hour on days -4 to -3. Patients undergo allogeneic PBSCT on day 0. Patients receive G-CSF SC beginning on day 7 and continuing until blood counts recover.

Patients receive graft-vs-host disease (GVHD) prophylaxis comprising oral tacrolimus twice daily on days -1 to 90 followed by a taper on days 91-150 and methotrexate IV on days 1, 3, and 6.

After day 120, patients with stable or progressive disease and no evidence of active GVHD may receive donor lymphocyte infusion (DLI) over 2 hours. Patients may receive up to 3 DLIs every 8 weeks.

Patients are followed every 3 months for 3 years, every 6 months for 5 years, and then annually for 15 years.

PROJECTED ACCRUAL: A maximum of 63 patients will be accrued for this study.

Keywords
refractory multiple myeloma, 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.

  • filgrastimBiological

    Also called G-CSF

    PBSC collection: 10 ug/kg/d subQ inj D 5 until completion of collection Auto transpl: 5 ug/kg/d subQ inj D 5 until ANC >= 1500/uL for 2d or 5000/uL for 1 d Allo transpl: 5ug/kg/d subQ inj D 7 until ANC > 1000/uL for 3 days Donor pheresis: 10ug/kg/d subQ inj d -5 thru -2

  • CD34+ cellsBiological

    2-8,000,000/kg IV infusion allogeneic transplant 2,000,000/kg IV infusion autologous transplant

  • cyclophosphamideDrug

    4g/sq m IV infusion over 1-2 hrs D 1 for auto, and 1g/sq m/d IV infusion over 1 hr on D -4 thru -3 for allo, transplant prep

  • fludarabine phosphateDrug

    30mg/sq m/d IVPB over 30 min d -7 thru -3 allo transpl

  • melphalanDrug

    200mg/sq m IV infusion over 15-30 min D 2 auto transpl

  • methotrexateDrug

    5mg/sq m/d IV infusion D 1,3,\& 6: allo transpl

  • tacrolimusDrug

    0.03mg/kg PO bid starting dose, D -1 thru +90, then taper thru D +150

Study groups in NCT00028600
Study groupRoleWhat they receive
Autologous + Allogeneic TransplantExperimentalautologous PB stem cell transplant followed by non-myeloablative allogeneic transplant fr multiple myeloma
Receives: Biological: filgrastim; Biological: CD34+ cells; Drug: cyclophosphamide; Drug: fludarabine phosphate; Drug: melphalan; Drug: methotrexate; Drug: tacrolimus

What is being measured

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

  1. Treatment-related mortality

    Measured: 6 months

Secondary outcomes (6)

  1. Treatment Completion Rate

    Measured: post treatment

  2. Respone Rate

    Measured: 2-4 wks prior, and 3,6 mon then q 3 mon for 3 yrs, post allo transpl, then q 6 mon for max 15 yrs from study entry

  3. Chimerism Rate

    Measured: 1,2,3,4, & 6 mon post allo transpl, & 100 d post DLI

  4. GVHD Incidence

    Measured: post allo transpl, & pre & post DLI

  5. Survival

    Overall and disease free survival will be assessed

    Measured: 2 years

  6. Correlation of cytogenetics and response

    Measured: 6, 12 mon then q 1 yr for 3 yrs post allo transpl

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 startNov 2001
  3. Primary completionJun 2006
  4. Study completionFeb 2010

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00028600
Sponsor's protocol ID
CALGB-100001
Other IDs
U10CA031946, CALGB-100001, CDR0000069109
Status last verified
Jul 2016
First submitted
4 Jan 2002
Last updated
4 Jul 2016
Results posted
No
Data monitoring committee
No

Publications

  • Holstein SA, Suman VJ, Owzar K, Santo K, Benson DM Jr, Shea TC, Martin T, Silverman M, Isola L, Vij R, Cheson BD, Linker C, Anderson KC, Richardson PG, McCarthy PL. Long-Term Follow-up of CALGB (Alliance) 100001: Autologous Followed by Nonmyeloablative Allogeneic Transplant for Multiple Myeloma. Biol Blood Marrow Transplant. 2020 Aug;26(8):1414-1424. doi: 10.1016/j.bbmt.2020.03.028. Epub 2020 Apr 20.

    PubMed 32325171

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing filgrastim, CD34+ cells and cyclophosphamide in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Alliance for Clinical Trials in Oncology at 15 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 4 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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 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?

Treatment-related mortality (time frame: 6 months). 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 NCT00028600, 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 4 Jul 2016.

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