A study for adults with Waldenstrom's macroglobulinaemia to investigate whether a new combination of 3 drugs (Bortezomib, Cyclophosphamide and Rituxumab) is safe and gives better response to treatment.

Phase 1

• Conditions: Waldenstrom's macroglobulinaemia (WM); MedDRA version: 14.1Level: LLTClassification code 10054695Term: Waldenstrom's macroglobulinemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2011-005156-34-GB
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-13
• Last Update Posted: 7 September 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

I. Age = 18 years
II. Confirmed diagnosis of WM with measurable IgM paraprotein
III.Previously untreated disease at any stage requiring therapy at the discretion of the treating physician. Suggested criteria for initiating treatment include:
a.haematological suppression to Hb <10 g/dl, or neutrophils <1.5x10(9)/l or platelets <150x10(9)/l
b.clinical evidence of hyperviscosity
c.bulky lymphadenopathy and/or bulky splenomegaly
d.presence of B symptoms
IV.No previous chemotherapy
V.Performance status grade 0 - 2
VI.Life expectancy of greater than 6 months
VII.Informed consent
VIII.Agreed compliance with recommended contraceptive precautions where appropriate

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

Exclusion Criteria

I. Lymphoplasmacytic lymphoma with no detectable serum IgM paraprotein
II. Severe pre-existing neuropathy (> grade 2)
III.Autoimmune cytopenias
IV. Evidence of active Hepatitis B or C infection
V. Serological positivity for HIV
VI. Pregnant or lactating women
VII.Life expectancy severely limited by other illness
VIII.Renal failure (creatinine clearance <30 ml/min)
IX. Severe impairment of liver function: alkaline phosphatase/bilirubin >2.5xULN, ALT/AST >2.5xULN not related to lymphoma
X. History of allergic reaction to compounds containing boron or mannitol
XI.Known hypersensitivity to murine compounds.
XII.Diagnosed or treated for a malignancy other than WM within 5 years with the exception of complete resection of basal cell carcinoma, squamous cell carcinoma of the skin or any other in situ malignancy
XIII.Active systemic infection requiring treatment
XIV. Concurrent treatment with another investigational agent
XV. Severe or life-threatening cardiac, pulmonary, neurological, psychiatric or metabolic disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified