An open, randomized clinical phase I/II trial to investigate maximum tolerated dose, efficacy, and safety of lenalidomide/low-dose dexamethasone in combination with continuous oral cyclophosphamide compared to lenalidomide/low-dose dexamethasone combined with single cyclophosphamide doses IV in patients with relapsed/refractory multiple myeloma

Phase 1

• Conditions: relapsed multiple myeloma; MedDRA version: 18.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2008-003829-16-DE
• Lead Sponsor: GMIHO - Gesellschaft für medizinische Innovation Hämatologie und Onkologie mbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-11
• Last Update Posted: 11 December 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Understand and voluntarily sign an informed consent form
2. Age = 18 years at the time of signing the informed consent form.
3. Able to adhere to the study visit schedule and other protocol requirements.
4. Previously diagnosed with multiple myeloma based on standard criteria and requires therapy for primary refractory disease or 1st – 3rd relapse because of progressive disease (PD), defined as a 25% increase in M-protein, development of new or worsening of existing lytic bone lesions or soft tissue plasmacytoma, or hypercalcemia (serum calcium > 11.3 mg/dL), or clinical relapse from CR.
5. At least one measurable disease manifestation defined as follows:
• For secretory multiple myeloma, measurable disease is defined as any quantifiable serum monoclonal protein value (generally, but not exclusively, > 1g/dL IgG M-protein or > 0.5 g/dL IgA) and, where applicable, urine light-chain excretion of = 200 mg/24 h.
• For oligo- or non-secretory multiple myeloma, measurable disease is defined by the presence of soft tissue (not bone) plasmacytomas as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan) or a quantifiable plasma cell infiltration of the bone marrow as determined by bone marrow biopsy.
6. ECOG performance status of <= 2 at time of randomization/registration
7. Laboratory test results within these ranges within 1 week prior to randomization/registration:
• Absolute neutrophil count = 1.5 x 109/L without the use of colony stimulating factors within 14 days before the laboratory test.
• Platelet count = 75 x 109/L without transfusion support within 14 days before the laboratory test.
• Hemoglobin = 7.5 g/dL (regardless of transfusion support or prior medication with erythropoietin).
• Calculated creatinine clearance = 50 mL/minute.
• Total bilirubin <= 1.5 mg/dL.
• AST (SGOT) and ALT (SGPT) <= 2,5 x ULN.
• Corrected serum calcium < 14 mg/dL (< 3.5 mmol/L).
8. Contraception for females of childbearing potential and male subjects (For details see protocol)
9. Disease free of prior malignancies for = 5 years with exception of treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ” of the cervix or breast
10. Able and willing to take heparin (usually low-molecular weight - LMWH) or low acetylsalicylic acid (100 mg) daily as prophylactic anticoagulation.
11. Life-expectancy > 3 months.
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

1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
2. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
3. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
4. Patient currently is enrolled in another clinical research study or has been enrolled in such a study within 4 weeks before randomization/registration and/or is receiving an investigational agent for any reason or has received such an agent within 4 weeks before randomization/registration.
5. Known hypersensitivity to thalidomide, dexamethasone, or cyclophosphamide.
6. Any prior use of lenalidomide.
7. Concurrent use of other anti-cancer agents or treatments.
8. Known positive for HIV or currently active hepatitis, type A, B or C.
9. Any other chemotherapy or high-dose dexamethasone within 4 weeks before randomization/registration.
10. Immunotherapy or antibody therapy within 8 weeks before randomization/registration.
11. Major surgery within 4 weeks before randomization/registration.
12. Myocardial infarction within 6 months before randomization/registration, New York Heart Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
13. Cardiac amyloidosis.
14. Poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to the protocol.
15. Any systemic infection requiring treatment.
16. Cystitis.
17. Disturbance of urinary flow.
18. Unable or unwilling to take heparin (usually low-molecular weight - LMWH) or low acetylsalicylic acid (100 mg) daily as prophylactic anticoagulation.

Study & Design

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