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Radioimmunotherapy (RIT) in MULTIPLE MYELOMA Using the Antibody B-B4 Radiolabelled With IODE 131 (BB4)

This study has been completed.
Sponsor:
Information provided by:
Centre René Gauducheau
ClinicalTrials.gov Identifier:
NCT01296204
First received: February 11, 2011
Last updated: March 21, 2011
Last verified: February 2011
History of Changes
  Purpose

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.

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Condition Intervention Phase
Multiple Myeloma
 Drug: BB4 antibody-Iodine 131
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I of Radioimmunotherapy (RIT) in MULTIPLE MYELOMA Using the Antibody B-B4 Radiolabelled With IODE 131

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre René Gauducheau:

Primary Outcome Measures:
  • The dose limiting toxicities (DLT) will be analysed in order to determine the maximal tolerated dose (MTD) in a dose escalation study design. [ Designated as safety issue: Yes ]

Estimated Enrollment: 33
Arms Assigned Interventions
Experimental: BB4 antibody-Iodine 131 Drug: BB4 antibody-Iodine 131
Injection of an antibody after labelling with Iodine 131

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 chemotherapy or radiotherapy within 4 weeks before inclusion
  • No major surgery within 4 weeks preceding the assessment of inclusion
  • 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
  • Platelets ≥ 100 000/mm3

Exclusion Criteria:

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01296204

Locations
France
Centre René Gauducheau
Nantes, France, 44805
Moreau
Nantes, France
Sponsors and Collaborators
Centre René Gauducheau
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01296204     History of Changes
Other Study ID Numbers: 04/1B
Study First Received: February 11, 2011
Last Updated: March 21, 2011
Health Authority: France : Afssaps

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
 Antibodies
Immunoglobulins
Iodine
Cadexomer iodine
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Trace Elements
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on June 17, 2013