NCT00938626

Brief Summary

RATIONALE: Giving chemotherapy followed by treated T cells before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or by killing them. After treatment, stem cells are collected from the patient's blood and stored. High-dose chemotherapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. PURPOSE: This phase I trial is studying the side effects and best way to give treated T cells followed by stem cell transplant in treating patients with multiple myeloma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 14, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

September 23, 2013

Status Verified

September 1, 2013

Enrollment Period

2 years

First QC Date

July 11, 2009

Last Update Submit

September 20, 2013

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

refractory multiple myelomastage I multiple myelomastage II multiple myelomastage III multiple myeloma

Outcome Measures

Primary Outcomes (2)

  • Cell-based toxicities according to NCI CTCAE v3.0 criteria

    Up to week 4 after chemotherapy

  • Ability to mobilize the number of stem cells required for autologous peripheral blood stem cell transplantation (PBSCT)

    By day 30 after autologous stem cell transplant (ASCT)

Secondary Outcomes (3)

  • Engraftment of neutrophils

    At day 28 after autologous PBSCT

  • Functional changes in immune cell populations

    Prior to immunotherapy (IT), after IT, high dose chemotherapy (HDC)/ autologous stem cell transplant (ASCT) and boost infusion

  • Assess proportion of erythroid blast-forming unit (BFU)-E, colony forming unit-granulocyte-macrophage (CFU)-GM, CFU-GEMM (granulocyte, erythrocyte, monocyte, megakaryocyte) & erythroid colony forming (CFU-E)

    Prior to induction or salvage chemotherapy; Pre & post IT

Study Arms (1)

Armed-activated T cells/Immunotherapy

EXPERIMENTAL

At least 1-3 weeks after the second infusion, patients receive high-dose chemotherapy and then undergo autologous peripheral blood stem cell transplantation. Patients then undergo leukapheresis for G-CSF-mobilized autologous T-cells.

Biological: anti-CD3 x anti-CD20 bispecific antibody-armed activated T cellsProcedure: autologous hematopoietic stem cell transplantationProcedure: peripheral blood stem cell transplantation

Interventions

anti-CD3 x anti-CD20 bispecific antibody-armed activated T cellsBIOLOGICAL

After completion of induction or salvage chemotherapy, patients receive immunotherapy comprising anti-CD3 x anti-CD20-armed ATC IV weekly for 2 weeks.

Armed-activated T cells/Immunotherapy
autologous hematopoietic stem cell transplantationPROCEDURE

At least 1-3 weeks after the second infusion, patients receive high-dose chemotherapy and then undergo autologous peripheral blood stem cell transplantation. Patients then undergo leukapheresis for G-CSF-mobilized autologous T-cells.

Armed-activated T cells/Immunotherapy
peripheral blood stem cell transplantationPROCEDURE

At least 1-3 weeks after the second infusion, patients receive high-dose chemotherapy and then undergo autologous peripheral blood stem cell transplantation.

Armed-activated T cells/Immunotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of multiple myeloma * Candidate for high-dose chemotherapy and autologous stem cell transplantation * No definite morphologic evidence of myelodysplasia on pretreatment bone marrow PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-2 or Karnofsky PS 70-100% * ANC \> 500/mm\^3 * Platelet count ≥ 75,000/mm\^3 * Total bilirubin ≤ 2.0 mg/dL * AST and ALT ≤ 3 times upper limit of normal * Creatinine ≤ 2.0 mg/dL * LVEF ≥ 45% * Corrected pulmonary diffusion capacity ≥ 50% * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No uncontrolled infections or other severe medical problems such as adrenal dysfunction * No other active malignancy (except for nonmelanoma skin cancer) that requires myelosuppressive chemotherapy or radiotherapy * No HIV infection PRIOR CONCURRENT THERAPY: * See Disease Characteristics * On-chemotherapy induction with thalidomide or lenalidomide with dexamethasone is allowed * No prior stem cell transplantation * No more than 2 prior treatment regimens (including the one during which patients undergo leukapheresis for T-cells) * No more than 4 courses of lenalidomide in combination with other agents or as a single agent over a 1-year period * No other concurrent immunotherapy, radiotherapy, chemotherapy, or anti-myeloma therapy at the time of the anti-CD3 x anti-CD20-armed ATC infusion

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Interventions

Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Hematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Jeffrey A. Zonder, MD

    Barbara Ann Karmanos Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 11, 2009

First Posted

July 14, 2009

Study Start

October 1, 2009

Primary Completion

October 1, 2011

Study Completion

March 1, 2013

Last Updated

September 23, 2013

Record last verified: 2013-09

Locations

US(1)