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Multiple Myeloma and Plasma Cell NeoplasmPhase 2NCT00002630

High-Dose Melphalan, Total-Body Irradiation, and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma in First Relapse

A Phase 2 study testing filgrastim, cyclophosphamide and melphalan in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Mayo Clinic at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
filgrastim, cyclophosphamide and melphalan
Type of treatment
Surgery or procedure
How many people
50 participants
Where
2 sitesUnited States
Study dates
Jun 1993to May 2001
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS: Multiple myeloma confirmed by bone marrow plasmacytosis and with measurable M-component in the serum or urine by immunoelectrophoresis or immunofixation No Stage I myeloma No smoldering multiple myeloma Refractory to or in first relapse following an initial response to VAD (vincristine/doxorubicin/dexamethasone), with relapse defined as any of the following: 50% increase above the lowest remission level of serum or urine M-protein while on therapy 25-50% increase above the lowest remission level of serum or urine M-protein associated with either: Hypercalcemia (greater than 11 mg/dl) Hb decrease of 2 g/dl attributable to increasing marrow plasmacytosis Appearance of new lytic lesions Calcium no greater than 11 mg/dl No myeloma meningitis No plasma cell leukemia

PATIENT CHARACTERISTICS: Age: 18 to 65 Performance status: ECOG 0-2 Hematopoietic: WBC greater than 500 (after G-CSF) Platelets greater than 25,000 Hepatic: Bilirubin no greater than 2.0 mg/dl Renal: Creatinine no greater than 2.0 mg/dl Cardiovascular: No NYHA class II-IV disease Pulmonary: DLCO at least 50% of predicted FVC at least 75% of predicted FEV1 at least 60% of predicted Other: No uncontrolled infection No active fungal infection No fever No prior malignancy within 5 years except: Basal cell skin cancer In situ carcinoma of the cervix No pregnant or nursing women

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biological response modifiers allowed Chemotherapy: No time limit between cytotoxic therapy and protocol treatment Prior cumulative melphalan dose less than 300 mg Endocrine therapy: Corticosteroids for hypercalcemia allowed Radiotherapy: Prior radiotherapy allowed Prior pelvic radiotherapy allowed, but patients with such therapy are unlikely to have adequate PBSC harvested Surgery: Not specified

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: HIGH-DOSE MELPHALAN CHEMOTHERAPY AND TOTAL BODY RADIATION WITH PERIPHERAL BLOOD STEM-CELL RECONSTITUTION FOR PATIENTS WITH RELAPSING MULTIPLE MYELOMA

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining peripheral stem cell transplantation with chemotherapy and radiation therapy may allow the doctor to give higher doses of radiation and chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of high-dose melphalan plus total-body irradiation and peripheral stem cell transplantation in treating patients with multiple myeloma in first relapse.

Read the detailed description

OBJECTIVES: I. Assess bone marrow reconstitution and peripheral blood cell counts of patients with multiple myeloma treated with high-dose melphalan (L-PAM) and total-body irradiation (TBI) followed by peripheral blood stem cell (PBSC) rescue. II. Assess the efficacy of intravenous L-PAM and TBI for treatment of relapsing/refractory myeloma. III. Assess the tolerability and toxicity of this regimen in patients with relapsing multiple myeloma. IV. Assess response rate and survival of relapsing/refractory patients treated with this regimen.

OUTLINE: Prior to entry, patients will have received 3 monthly courses of standard VAD followed by PBSC collection on Regimen A; those who responded to VAD continue standard VAD to best response and upon relapse (on or off therapy) proceed to Regimen B. Patients with no response to 3 courses of VAD and those with no response to an alkylating-based regimen proceed immediately to Regimen B following PBSC collection. The following acronyms are used: CTX Cyclophosphamide, NSC-26271 G-CSF Granulocyte Colony Stimulating Factor (Amgen), NSC-614629 L-PAM Melphalan, NSC-8806 PBSC Peripheral Blood Stem Cells VAD Vincristine/Doxorubicin/Dexamethasone TBI Total Body Irradiation Regimen A: Stem Cell Mobilization/Harvest. CTX; G-CSF. Regimen B: Single-Agent Myeloablative Chemoradiotherapy with Stem Cell Rescue. L-PAM; TBI (Co60 or linear accelerators of 4 MV or greater); with PBSC.

PROJECTED ACCRUAL: If 9 or fewer or 20 or more responses are seen in the first 50 patients treated, the study will be discontinued.

Being tested
filgrastim, cyclophosphamide, melphalan, peripheral blood stem cell transplantation, low-LET cobalt-60 gamma ray therapy
Keywords
refractory multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
Medical subject headings
Multiple Myeloma, Neoplasms, Plasma Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2004 (estimated)
  2. Study startJun 1993
  3. Primary completionFeb 1999
  4. Study completionMay 2001

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002630
Sponsor's protocol ID
CDR0000064030
Other IDs
P30CA015083, 928003, V95-0613
Status last verified
May 2011
First submitted
1 Nov 1999
Last updated
11 May 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Porrata LF, Gertz MA, Inwards DJ, Litzow MR, Lacy MQ, Tefferi A, Gastineau DA, Dispenzieri A, Ansell SM, Micallef IN, Geyer SM, Markovic SN. Early lymphocyte recovery predicts superior survival after autologous hematopoietic stem cell transplantation in multiple myeloma or non-Hodgkin lymphoma. Blood. 2001 Aug 1;98(3):579-85. doi: 10.1182/blood.v98.3.579.

    PubMed 11468153

  • Rajkumar SV, Fonseca R, Dispenzieri A, Lacy MQ, Witzig TE, Lust JA, Larson D, Therneau TM, Kyle RA, Litzow MR, Greipp PR, Gertz MA. Effect of complete response on outcome following autologous stem cell transplantation for myeloma. Bone Marrow Transplant. 2000 Nov;26(9):979-83. doi: 10.1038/sj.bmt.1702640.

    PubMed 11100277

  • Gertz MA, Lacy MQ, Inwards DJ, Gastineau DA, Tefferi A, Chen MG, Witzig TE, Greipp PR, Litzow MR. Delayed stem cell transplantation for the management of relapsed or refractory multiple myeloma. Bone Marrow Transplant. 2000 Jul;26(1):45-50. doi: 10.1038/sj.bmt.1702445.

    PubMed 10918404

  • Gertz MA, Lacy MQ, Inwards DJ, Chen MG, Pineda AA, Gastineau DA, Greipp PR, Lust JA, Tefferi A, Witzig TE, Kyle RA, Litzow MR. Early harvest and late transplantation as an effective therapeutic strategy in multiple myeloma. Bone Marrow Transplant. 1999 Feb;23(3):221-6. doi: 10.1038/sj.bmt.1701559.

    PubMed 10084252

  • Rajkumar S, Fonseca R, Lacy M, Witzig T, Lust J, Greipp P, Therneau T, Kyle R, Litzow M, Gertz M. Abnormal cytogenetics predict poor survival after high-dose therapy and autologous blood cell transplantation in multiple myeloma. Bone Marrow Transplant. 1999 Sep;24(5):497-503. doi: 10.1038/sj.bmt.1701943.

    PubMed 10482933

  • Rajkumar SV, Fonseca R, Dewald GW, Therneau TM, Lacy MQ, Kyle RA, Greipp PR, Gertz MA. Cytogenetic abnormalities correlate with the plasma cell labeling index and extent of bone marrow involvement in myeloma. Cancer Genet Cytogenet. 1999 Aug;113(1):73-7. doi: 10.1016/s0165-4608(99)00009-6.

    PubMed 10459351

  • Rajkumar SV, Fonseca R, Lacy MQ, Witzig TE, Lust JA, Greipp PR, Therneau TM, Kyle RA, Litzow MR, Gertz MA. Autologous stem cell transplantation for relapsed and primary refractory myeloma. Bone Marrow Transplant. 1999 Jun;23(12):1267-72. doi: 10.1038/sj.bmt.1701805.

    PubMed 10414914

  • Rajkumar SV, Fonseca R, Lacy MQ, Witzig TE, Lust JA, Greipp PR, Therneau TM, Kyle RA, Litzow MR, Gertz MA. Beta2-microglobulin and bone marrow plasma cell involvement predict complete responders among patients undergoing blood cell transplantation for myeloma. Bone Marrow Transplant. 1999 Jun;23(12):1261-6. doi: 10.1038/sj.bmt.1701787.

    PubMed 10414913

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing filgrastim, cyclophosphamide and melphalan in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Mayo Clinic at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002630, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2011.

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