Skip to main content
OpenTrials
Completed

NCT Number: NCT01296204

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre René Gauducheau, Nantes, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BB4 antibody-Iodine 131

Drug

Injection of an antibody after labelling with Iodine 131

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.

Sponsors and collaborators

Lead sponsor

Centre René Gauducheau

Other

Registry information

Official study title

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

Acronym: BB4

Important dates

First posted
Feb 15, 2011
Registry last updated
Mar 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.