NCT01296204

Brief Summary

The first step of this protocol called step pre-treatment study the biodistribution and pharmacokinetics of a tracer dose of radiolabeled antibody. The second step called step therapy study the toxicity and antitumor effects of antibody B-B4 coupled with increasing doses of iodine 131. At least 17 patients will be included for an estimated duration of 2 years to determine the maximum tolerated dose and dose limiting toxicity. The immediate side effects, medium and long terms will be analyzed. After determining the toxic dose limit, patients will be treated at the maximum tolerated dose, for a total of 15 patients at this level, which will measure the objective tumor response to treatment. These patients will be followed for 1 year after injection therapy. ÉcouterLire phonétiquement

Trial Health

80
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P50-P75 for phase_1 multiple-myeloma

Geographic Reach
1 country

2 active sites

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

February 11, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 15, 2011

Completed
Last Updated

March 22, 2011

Status Verified

February 1, 2011

First QC Date

February 11, 2011

Last Update Submit

March 21, 2011

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • The dose limiting toxicities (DLT) will be analysed in order to determine the maximal tolerated dose (MTD) in a dose escalation study design.

Study Arms (1)

BB4 antibody-Iodine 131

EXPERIMENTAL
Drug: BB4 antibody-Iodine 131

Interventions

BB4 antibody-Iodine 131DRUG

Injection of an antibody after labelling with Iodine 131

BB4 antibody-Iodine 131

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a confirmed diagnosis of multiple myeloma (\> 10% plasma cells on a previous myelogram)
  • Secretion of a monoclonal immunoglobulin
  • No myelodysplasia evaluated by myelogram
  • Disease refractory or relapsed after at least 3 lines of therapy
  • Patients with a dated and signed the consent form
  • Collection of autologous peripheral blood stem cells containing at least 2. 106 CD 34 + cells / kg
  • Age\> 18 years
  • Performance status \<2 (see Annex I), life expectancy of more than 3 months
  • No bisphosphonates within 2 weeks prior radioimmunotherapy, except for treatment started more than three months ago.
  • Normality of the biological assessment:
  • Creatinine less than or equal to 1.5 times the normal laboratory
  • Liver: less than or equal to 1.5 times the normal laboratory (free and conjugated bilirubin, SGOT, SGPT, gamma GT PAL)
  • Hemoglobin ≥ 8 g/mm3
  • ≥ 3 WBC 000/mm3
  • Neutrophils ≥ 1 500/mm3
  • +1 more criteria

You may not qualify if:

  • Patients with other cancers except uterine carcinoma in situ or basal cell skin carcinoma
  • Patients with other (s) condition (s) Severe (s) to prevent tolerance to study and conduct the study to completion
  • Patient is pregnant or unwilling to take a contraceptive treatment for three months after treatment
  • Collection of peripheral blood stem cells containing less than 2106 CD 34 + cells / kg
  • Patients enrolled in another experimental treatment protocol
  • Patients who already received treatment with radioimmunotherapy
  • Myelodysplasia assessed by myelogram
  • Patient with thyroid
  • Patient unable to sign informed consent ÉcouterLire phonétiquement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre René Gauducheau

Nantes, 44805, France

Location

Moreau

Nantes, France

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 11, 2011

First Posted

February 15, 2011

Last Updated

March 22, 2011

Record last verified: 2011-02

Locations

FR(2)