A forward-looking study to assess disease remission in patients with newly diagnosed blood cancer (multiple myeloma) who will be treated with a combination of three drugs followed by transplantation of own blood stem cells and maintainance therapy with one of the drugs (lenalidomide). Disease remission is measured with a method which can determine the presence of cancer cells in the bone marrow.

Phase 1

• Conditions: Multiple myeloma; MedDRA version: 15.0Level: PTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-001051-39-FI
• Lead Sponsor: Kuopio University Hospital, Clinic of Internal Medicine/Center of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-26
• Last Update Posted: 26 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

- Age 18 - 70 years
- Written informed consent
- Patients with a symptomatic, previously untreated, ISS 1-3 multiple myeloma
- Measurable disease: serum paraprotein > 10g/l or urine paraprotein > 200mg/24 hours or abnormal free light chain ratio
- WHO performance status 0-3 (if WHO 3, must be related to myeloma, not due to comor-bidities)
- Eligible for ASCT
- Sufficient renal function, glomerular filtration rate (GFR) assessed by Modification of Diet in Renal Disease formula (MDRD) > 15 ml/min unless on hemodialysis
- Women of childbearing potential (WCBP) must have a negative serum or urine preg-nancy test prior to starting lenalidomide. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, patches, or implantable hormonal contraceptive methods; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasecomized partner) while on lenalidomide. WCBP must agree to have pregnancy tests every 4 weeks while on lenalidomide.
- Males (including those who have had a vasectomy) must use barrier contraception (latex condoms) when engaging in reproductive sexual activity with WCBP while on lenalidomide, when temporarily stopping lenalidomide and 28 days after the last dose of lenalidomide.

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

Exclusion Criteria

- Previous chemotherapy or radiotherapy except local radiotherapy (10-20 Gy) or corticos-teroids maximum dexamethasone 160 mg in two weeks before study inclusion for symptom control
- Peripheral neuropathy grade = 2
- Contraindication to use of thromboembolic prophylaxis
- Significant hepatic dysfunction (serum bilirubin 3 x >ULN, transaminases = 2,5 x upper limit), unless related to myeloma
- Severe cardiac dysfunction
- Severe renal failure, GFR < 15ml/min, if not in hemodialysis
- Other serious medical or psychiatric illness
- Uncontrolled infection
- Patients with a history of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma
- Pregnancy
- Lactating women
- HIV-positive patients, HBsAg or HCV positive patients
- Primary plasma cell leukemia
- Systemic AL amyloidosis or myeloma associated amyloidosis if not eligible for ASCT
- Allogeneic stem cell transplantation planned
- Participants receiving any other investigational agents
- Participants with known brain metastases

Study & Design

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